Neues aus der Welt der Antikörper und Immunother.
Damit möchte ich einen Überblick gewinnen und schaffen über die derzeitige Entwicklung auf dem Gebiet der Antikörpertherapien + Immunotherapien, natürlich vorwiegend soweit börsennotierte Unternehmen involviert sind. Da es sich um einen neueren Threapieansatz handelt - derzeit sind laut 'Nature' 18 Medikamente zugelassen, die auf
Antikörpern basieren, wird die weitere kommerzielle Nutzung des Therapieansatzes und damit auch die Börsenkurse der betroffenen Unternehmen von weiteren Zulassungserfolgen abhängen.
Dieser Trend soll hier beobachtet und ggf. kommentiert werden. Ergänzungen willkommen.
http://www.eurekalert.org/pub_releases/2005-10/foec-nma103105.php
Public release date: 31-Oct-2005
[ Print Article | E-mail Article | Close Window ]
Contact: Kirsten Mason
kirsten.mason@toniclc.com
44-077-969-55353
Federation of European Cancer Societies
New monoclonal antibody therapies offer significant survival advantage for breast cancer patients
Paris, France, Monday 31 October 2005 - Results from the first and only interim analysis of an important trial assessing the potential of Herceptin (trastuzumab) to improve disease-free survival (DFS) in HER-2 positive breast cancer patients after adjuvant chemotherapy, have shown that Herceptin affords a significant survival advantage. These new findings were released at the 13th European Cancer Conference (ECCO) on the recommendation of the Independent Data Monitoring Committee.The study in question, an international, multicentre, randomised, 3-arm trial is being conducted by the Breast International Group (BIG) in collaboration with the pharmaceutical company Roche AG, manufacturers of Herceptin. In total, 5,090 early breast cancer patients have been enrolled into this trial by the 478 participating institutions from Europe, Canada, South Africa, Israel, the Asia Pacific Region, Japan and Latin America. All women accrued had HER-2 positive breast cancer (either node negative or positive) and had completed at least four cycles of an acceptable (neo) adjuvant chemotherapy regimen. For women with hormone receptor positive disease, adjuvant endocrine therapy (most commonly tamoxifen) followed chemotherapy. The average age of study participants is 49 years.
The aim of this trial is to compare the effect of 1 year of Herceptin infusions, given every 3 weeks, with one year of simple observation, on survival – primarily DFS but also overall survival (OS), relapse-free survival (RFS) and distant disease free survival (DDFS), as well as comparable assessment of overall and cardiac safety. The study also consists of a 2-year arm – where 2 years of 3-weekly Herceptin is being compared with observation.
Results from the 1-year arm of the study, showcased at ECCO 13, show that Herceptin is associated with a significant improvement in DFS in this group of patients. The difference in Herceptin treated women was 85.8% compared to 77.4% of women on observation alone. Patients receiving Herceptin therapy for 1 year also showed significant improvements in other survival measures – including RFS and DDFS. OS was also better in the Herceptin group versus observation, although the difference was not significant. In terms of safety, Herceptin-treated women experienced a higher incidence of cardiac side effects, which occurred in 0.5% of patients. In contrast, no observational patient experienced an adverse cardiac event.
These positive results are further supported by preliminary survival data from the 2-year Herceptin arm which also demonstrate a highly significant improvement in DFS compared with observation (p<0.0001). This important trial is continuing, gathering further data to assess and compare 2 years versus 1 year of Herceptin treatment, as well as carefully monitoring potential late-stage effects.
Professor Michael Untch, the study's Principle Investigator, from the Frauenklinik der LMU München Klinikum Grosshadern, Germany remarked: "These notable early findings show that Herceptin can provide significant improvements in survival for women with early HER-2 positive breast cancer who have completed initial chemotherapy cycles. By reducing the incidence of recurrences and metastasis by 50 % it means that patients have a significant gain in their chance to survive and a tremendous increase of their life quality. "
Another new monoclonal antibody, bevacizumab has recently completed Phase III clinical trials for the treatment of locally advanced or metastatic breast cancer. Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) and acts to inhibit tumour angiogenesis (process of diverting nutrients to the tumour).
The randomised Phase III trial was coordinated by the Eastern Cooperative Oncology Group to compare the efficacy and safety of paclitaxel with or without bevacizumab as first line therapy in patients with locally advanced or metastatic breast cancer. 722 patients were recruited between December 2001 and May 2004 and were divided into two groups receiving either paclitaxel alone or the combination of paclitaxel and bevacizumab. The primary endpoint was progression-free survival (PFS).
The results were positive and indicated that the combination of paclitaxel and bevacizumab improved overall survival of patients than receiving paclitaxel alone (no final data available yet). Importantly the progression-free survival was improved with combination therapy, 10.97 months vs 6.11 months for paclitaxel alone. In addition, the investigators noted that combination therapy did not cause significant toxicity effects.
Speaking at ECCO 13, Dr Kathy Miller from the Indiana University Cancer Centre, USA, commented, "This is the first study to confirm the benefit of anti-angiogenic therapy in patients with breast cancer. Importantly, the improvements in response rate and progression-free survival were obtained with minimal increase in side effects. Given the benefit of bevacizumab in patients with metastatic disease, we look forward to initiating trials in the adjuvant setting."
###
About Breast cancer
Breast cancer is a malignant tumour that usually begins in the milk ducts (ductal carcinoma) or lobules or milk producing tissue (lobular carcinoma) of the breast. Either type if diagnosed early enough, may be called 'in situ' which means the cancer has not spread or invasive if it has. Rarer breast cancers affect other types of breast tissue.
Breast cancer is the most commonly diagnosed cancer in women, nearly 1 in 3 of all cancers in women occur in the breast.1 80% of breast cancers appear in post-menopausal women. Although rarer, some men can suffer from breast cancer.
Associated risks of breast cancer can be attributed to genetics, early onset of menstruation, no pregnancies or first pregnancy after the age of thirty, previous breast disorders, alcohol, smoking and diet.2
Treatment depends on the staging of the disease, classified from I to IV (higher the number, the more advanced the cancer). Surgery and radiotherapy is usually first line treatment, however hormone or chemotherapy treatment can be given first to shrink the tumours. The majority of breast cancers are hormone responsive and can be treated with oestrogen blockers such as tamoxifen or the newer aromatose inhibitors which are normally administered after surgery to prevent the cancer returning.
In non-hormone responsive breast cancers, which includes those with a genetic predisposition to breast cancer and who are carrying the HER2 gene, the new drug Herceptin offers hope. It is successful in blocking the growth-promoting protein found on the surface of most breast cancers thereby preventing the spread of the cancer.3 Recently other types of biological therapies similar to Herceptin are starting to show promise in the treatment of advanced breast cancers.
For further information please contact:
Tonic Life Communications:
Stéphanie Makin: + 44 7769 673 973 or e-mail stephanie.makin@toniclc.com or
Kirsten Mason: + 44 7796 955 353 or e-mail kirsten.mason@toniclc.com
Press room:
Telephone: + 33 (0)1 40 68 27 45/ + 33 (0)1 40 68 27 46
Telefax: + 33 (01) 40 68 27 49/ + 33 (01) 40 68 27 52
For any enquiries after Thursday 3rd November 2005, please contact:
Stéphanie Makin: + 44 (0)20 7798 9905 or e-mail stephanie.makin@toniclc.com or
Kirsten Mason: + 44 (0)20 7798 9911 or e-mail kirsten.mason@toniclc.com
1 www.breastcancercare.org.uk
2 Information from breastcancercare.org.uk and Canadian Cancer Society
3 www.cancer.org
http://de.biz.yahoo.com/051004/217/4ppb3.html
PR Newswire
Patientenregistrierung für klinische Forschungsstudie zur Wirkung von REOPRO(R) (abciximab) bei akutem ischämischen Schlaganfall vorläufig ausgesetzt
Mittwoch 5. Oktober 2005, 01:06 Uhr
HORSHAM, Pennsylvania und INDIANAPOLIS, October 5 /PRNewswire/ -- Centocor, Inc. und Eli Lilly and Company gaben heute bekannt, dass die
Registrierung für die AbESTT II-Studie (Abciximab in Emergent Stroke
Treatment Trial-II) (AbESTT-II), die Studie der Phase III für REOPRO(R)
(abciximab) zur Behandlung eines akuten ischämischen Schlaganfalls, vorläufig
ausgesetzt wurde. Der unabhängige Ausschuss für die Studie SEMC (Safety and
Efficacy Monitoring Committee; Ausschuss zur Überwachung von Sicherheit und
Wirksamkeit) stellte anhand der bisher gesammelten Studiendaten
ANZEIGE
Sicherheitsbedenken fest und bewertet gegenwärtig das gesamte
Nutzen-Risiko-Profil von REOPRO für Patienten mit einem akuten ischämischen
Schlaganfall, bevor er endgültig entscheidet, ob die Studienregistrierung
fortgesetzt werden soll. Die zur Zeit für die Studie registrierten Patienten
erhalten das Medikament nicht weiter, die Daten für diese Patienten werden
überprüft, bevor der SEMC seine Empfehlung abgibt, wie mit der Studie
AbESTT-II weiter zu verfahren ist.
"Unsere erste Priorität ist die Sicherheit. Deshalb stoppen wir die
Registrierung, damit der SEMC die Daten sorgfältig auswerten und festlegen
kann, ob das Nutzen-Risiko-Profil für REOPRO zur Behandlung des akuten
ischämischen Schlaganfall zulässt, die Registrierung zur Studie
wiederaufzunehmen", sagte Dr. Jerome A. Boscia, Senior Vice President für
Klinische F&E bei Centocor, Inc. "Es ist jedoch wichtig anzumerken, dass
REOPRO für seine genehmigten Einsatzbereiche bei Patienten, die sich
Eingriffen am Herzen, wie einer Angioplastie oder Stent-Implantation,
unterziehen, über ein etabliertes positives Nutzen-Risiko-Profil verfügt."
REOPRO gilt gegenwärtig als Mittel zur Unterstützung einer perkutanen
Koronarintervention (PCI) zur Verhinderung von ischämischen
Herzkomplikationen bei Patienten, die sich einer PCI unterziehen, sowie bei
Patienten mit instabiler Angina, die auf herkömmliche medikamentöse Therapie
nicht ansprechen, wenn die perkutane Koronarintervention innerhalb von 24
Stunden geplant ist. Die Unternehmen unterstreichen noch einmal eindeutig,
dass sie keinerlei neue Daten kennen, die das positive Produktprofil für
REOPRO unter genehmigten Indikationen ändern, also unter Indikationen, die
durch über 14 randomisierte klinische Studien und durch ein ganzes Jahrzehnt
klinischer Erfahrungen unterstützt werden. Die gegenwärtige Studie AbESTT-II
bewertet die Sicherheit und Wirksamkeit von REOPRO bei Patienten mit akutem
ischämischen Schlaganfall.
Über AbESTT-II
AbESTT-II ist eine multinationale, multizentrische, randomisierte,
doppeltblinde, placebokontrollierte Studie der Phase 3, die die
Sicherheit und Wirksamkeit von REOPRO zur Verbesserung der neurologischen
Funktion und zur Minimierung der Behinderung bei Patienten bewertet, die
einen akuten ischämischen Schlaganfall erlitten haben. Vorläufige Ergebnisse
aus anderen Studien legen nahe, dass sich REOPRO für die
Schlaganfallbehandlung über das Zeitfenster von drei Stunden hinaus als
nützlich erweisen könnte, innerhalb dessen die einzige, zur Zeit genehmigte
Therapie eingesetzt wird, um bei Patienten mit ischämischen Schlaganfall
Blutgerinnsel aufzulösen. Die meisten Schlaganfallpatienten kommen erst
später als drei Stunden nach Einsetzen der Symptome in der Notaufnahme an.
Die Studie bewertet zwei Populationen: innerhalb von 4,5 Stunden
randomisierte Patienten mit einer geplanten Behandlung innerhalb von fünf
Stunden nach Beginn des Schlaganfalls (primäre Analysepopulation, n=1200) und
eine begleitende Population von Patienten, die 4,5 bis 5,5 Stunden nach dem
beginnenden Schlaganfall randomisiert werden und bei denen die geplante
Behandlung innerhalb von sechs Stunden begonnen wird oder die mit
Schlaganfallsymptomen aufwachen und innerhalb von 2,5 Stunden nach dem
Erwachen randomisiert werden (n=600). Im Mai 2005 wurde die Behandlung jenes
kleinen Segmentes an Patienten, die nach einem erlittenen Schlaganfall
aufgewacht sind, aufgrund eines erhöhten intrakraniellen Blutungsrisikos in
dieser Population eingestellt. Zu diesem Zeitpunkt empfahl der SEMC die
Fortführung der Registrierung, wobei die verbleibenden Gruppen in der Studie
bewertet werden sollten.
An dieser weltweiten klinischen Studie 'AbESTT-II', die 2003 begann,
nehmen ca. 150 Institutionen teilen. Ziel waren 1800 registrierte Teilnehmer.
Über den akuten ischämischen Schlaganfall
Ein akuter ischämischer Schlaganfall tritt ein, wenn im Gehirn ein
Blutgefäss blockiert wird. Diese Blockade verhindert, dass Sauerstoff und
Nährstoffe im Blut zu einem bestimmten Gehirnteil gelangen, wodurch dieses
abstirbt. Ungefähr 85 % aller Schlaganfälle gelten als ischämisch, werden
also durch ein Blutgerinnsel oder eine Ablagerung verursacht, das bzw. die im
Gehirn ein Blutgefäss blockiert. In den Vereinigten Staaten sind
Schlaganfälle die dritthäufigste Todesursache und führen jährlich zu über
150.000 Todesfällen.
Wichtige Sicherheitsinformationen
REOPRO kann potenziell - besonders bei anwesenden Antikoagulationsmitteln
, wie Heparin, oder anderer Gerinnungshemmer oder Thrombolytika - das Risiko
von Blutungen erhöhen. Das Risiko einer grösseren Blutung infolge einer
REOPRO-Therapie ist bei Patienten erhöht, die Thrombolytika einnehmen, und
sollte gegen die erwarteten Nutzeffekte abgewogen werden.
Zu den Richtlinien zur Verringerung von Blutungen zählen u. a.: der
Einsatz eines gering dosierten, an das Gewicht angepassten Heparinkur, die
Einstellung der Heparin-Einnahme bei Abschluss der Prozedur mit Entfernung
der Arterienscheide innerhalb von sechs Stunden, sorgfältige Beobachtung und
Behandlung der Gefässzugangsstelle und des Patienten insgesamt,
einschliesslich der nötigen Aufmerksamkeit für andere potenzielle
Blutungsstellen, Einsatz eines an das Gewicht angepassten Bolus und eine
kontinuierliche Infusionsdosis von REOPRO.
In klinischen Studien war die Wahrscheinlichkeit abnehmender
Thrombozytenmengen, einschliesslich schwerer Thrombozytopathien (siehe auch
unten: Erneute Verabreichung) bei Patienten, die mit REOPRO behandelt worden
waren, grösser als bei Patienten, die ein Placebo erhalten hatten.
Die Verabreichung von REOPRO kann zur Bildung humaner, antichimärer
Antikörper (HACA) führen, die potenziell allergische Reaktionen oder
Überempfindlichkeit, (einschliesslich Anaphylaxie), Thrombozytopenien oder
eine verringerte Wirkung bei erneuter Verabreichung hervorrufen kann. In
einer Registrierstudie zur erneuten Verabreichung von REOPRO (1342
Behandlungen bei 1286 Patienten) gab es keine Berichte über schwerwiegende
allergische Reaktionen oder Anaphylaxie. Fälle von Thrombozytopenien traten
in der Studie zur erneuten Verabreichung häufiger auf als in den Studien der
Phase 3 zur erstmaligen Verabreichung. Dies legt nahe, dass die erneute
Verabreichung u. U. mit einer gestiegenen Häufigkeit und Schwere von
Thrombozytopenien verbunden ist. Dieses erhöhte Risiko ging einher mit
Thrombozytopenien in der Vergangenheit bei vergangenen REOPRO-Zuführungen,
einer positiven HACA-Probe an der Basislinie und einer erneuten Verabreichung
innerhalb von 30 Tagen.
In Berichten über unerwünschte Wirkungen nach dem Vertrieb wurden seltene
Fälle von Anaphylaxie bei mit REOPRO behandelten Patienten gemeldet. Wenn
eine Überempfindlichkeit auftritt, ist die Verabreichung von REOPRO sofort
einzustellen, und es sind geeignete Wiederbelebungsmassnahmen einzuleiten.
Da REOPRO das Blutungsrisiko vergrössern kann, darf es in folgenden
klinischen Situationen nicht angewandt werden: aktive innere Blutungen,
kürzliche (innerhalb von sechs Wochen) Magen-Darm-Blutungen oder urogenitale
Blutungen von klinischer Bedeutung, Apoplexie in der Krankengeschichte
innerhalb der letzten zwei Jahre von oder Apoplexie mit einem bedeutenden
neurologischen Restdefizit, Blutungsdiathese, Verabreichung oraler
Gerinnungshemmer innerhalb von sieben Tagen, sofern die Prothrombinzeit
weniger oder gleich dem 1,2-fachen des Kontrollwertes liegt,
Thrombozytopenien (< 100.000 Zellen/pro Mikroliter), vor kurzem (innerhalb
der letzten sechs Wochen) erfolgte schwere Operationen oder Traumen,
intrakranielles Neoplasma, arteriovenöse Fehlfunktion oder Aneurysma, schwere
unkontrollierte Hypertonie, angenommene oder dokumentierte Vorgeschichte von
Vasculitis, Verwendung von intravenösem Dextran vor einem perkutanen
Herzeingriff oder bei geplanter Verwendung während des Eingriffs, bekannte
Überempfindlichkeit gegenüber einem Bestandteil dieses Produktes oder
gegenüber Mäuseproteinen.
REOPRO wurde von Centocor in Malvern, Pa., USA, entwickelt und von
Centocor, B.V. im niederländischen Leiden hergestellt. Eli Lilly and
Company vermarktet und vertreibt das Produkt weltweit, mit Ausnahme von
Japan.
Über Centocor
Centocor ist ein führendes biopharmazeutisches Unternehmen, das
kosteneffektive Therapien mit langfristigen Vorteilen für Patienten und
Gesundheitswesen entwickelt, akquiriert und vermarktet. Die Firma engagiert
sich in der Forschung und Entwicklung zur Behandlung einer breiten Palette an
Krankheiten, wie Krebs, Infektions-, Herz-Kreislauf- und Stoffwechsel- sowie
immunvermittelte Entzündungskrankheiten (I.M.I.D.), wie beispielsweise
Arthritis und Entzündungskrankheiten der Haut. Mit Centocors Produkten, die
vor allem durch monoklonale Antikörpertechnologie entwickelt werden, können
Ärzte innovative Behandlungsmöglichkeiten besser realisieren, um die
menschliche Gesundheit zu verbessern und die Lebensqualität der Patienten
wiederherzustellen. Centocor ist ein hundertprozentiges Tochterunternehmen
von Johnson & Johnson, dem weltweiten Hersteller von Gesundheitsprodukten.
Über Eli Lilly and Company
Lilly, ein führendes innovationsorientiertes Unternehmen, entwickelt ein
wachsendes Portfolio an pharmazeutischen 'First-In-Class'- und
'Best-In-Class'-Produkten, indem es die neuesten Forschungsergebnisse aus
firmeneigenen internationalen Laboratorien einsetzt und mit herausragenden
wissenschaftlichen Organisationen zusammenarbeitet. Das Unternehmen hat
seinen Hauptsitz in Indianapolis, Indiana, und bietet durch seine Medikamente
und Informationen Lösungen für einige der weltweit dringlichsten
medizinischen Probleme. Zusätzliche Informationen zu Lilly finden Sie unter
http://www.lilly.com.
Website: http://www.lilly.com
Centocor, Inc.; Eli Lilly and
UPDATE 1-Abbott's Humira promising for Crohn's Disease
Mon Oct 31, 2005 02:31 PM ET (Adds details, background, stock price)
NEW YORK, Oct 31 (Reuters) - Abbott Laboratories Inc. (ABT.N: Quote, Profile, Research) on Monday said its rheumatoid arthritis drug Humira showed positive results in a late-stage trial in treating the chronic intestinal condition Crohn's Disease.
The suburban Chicago company said 83 percent of patients who received the drug every week stayed disease-free for one year, while the rates of remission were 74 percent for those taking it every other week and 44 percent for those taking a placebo.
Abbott is presenting the results from its Phase 3 extension study, involving 55 patients whose moderate to severe disease went into remission after receiving Humira for four weeks, at a gastroenterology meeting this week.
William Sandborn of the Mayo Clinic's inflammatory bowel disease clinic called the results promising.
"There is no cure for Crohn's disease ... the next critical step is maintaining clinical remission, thereby preventing disease flares that may disrupt patients' lives," he said.
Crohn's Disease is a chronic inflammation of the intestinal wall that causes frequent diarrhea, cramping and abdominal pain.
Humira, which was recently approved to treat psoriatic arthritis, is Abbott's biggest product with global sales of $356 million during the third quarter.
Abbott shares were up 29 cents at $43.05 in afternoon trading on the New York Stock Exchange.
UCB Presents Positive Cimzia(TM) Results From Pivotal Phase III Crohn's Disease Trial at Major U.S. Medical Meeting
HONOLULU, Oct. 31 /PRNewswire/ -- A single 400 mg injection of Cimzia(TM) (certolizumab pegol, CDP 870) every four weeks was effective in maintaining control of the signs and symptoms of Crohn's disease following induction therapy, according to pivotal phase III research presented this week at the annual meeting of the American College of Gastroenterology.
The study, entitled PRECiSE 2, found that a significantly higher proportion of patients who responded to an induction regimen of 400 mg Cimzia(TM) at weeks zero, two and six, were able to maintain clinical response and achieve remission by week 26 when given a single injection every four weeks, compared to those treated with placebo. A regulatory submission for the treatment of Crohn's disease is planned in the US during the first quarter of 2006.
"As there is considerable unmet need in the treatment of Crohn's disease, it is important that the research community continue to explore new therapies," said William J. Sandborn, MD, professor of medicine, Mayo Clinic College of Medicine, Rochester, MN, PRECiSE study investigator. "These data are exciting because it shows that Cimzia(TM) holds significant promise in meeting many of these needs."
Crohn's disease is a chronic inflammatory bowel disorder that affects approximately one million people in the US and Europe alone.(1,2) Because there is no cure, treatment is focused on suppressing the inflammatory response that is at the root of its cause. Cimzia(TM) is a biologic agent that has been designed to inhibit the production of tumor necrosis factor alpha (TNF-alpha), a protein involved in the inflammation process.
Study Highlights -- 64 percent of the 668 patients enrolled in the trial responded to induction therapy by week 6. Those who responded were randomized to receive maintenance treatment with either Cimzia(TM) (n=216) or placebo (n=212). -- 62.8 percent of patients receiving Cimzia(TM) maintenance therapy sustained an overall clinical response throughout the 26-week study period, compared to 36.2 percent with placebo. -- The primary endpoints of PRECiSE 2 trial were met with statistical significance, irrespective of C-reactive protein (CRP, a marker of inflammation) status or prior exposure to anti-TNF therapy. -- 47.9 percent of patients receiving Cimzia(TM) maintenance therapy were in clinical remission at week 26, compared to 28.8 percent with placebo. -- Adverse events were mostly mild to moderate with the most common being headache (maintenance: certolizumab 6.9 percent; placebo 6.6 percent). Serious non-CD-related infections were observed in both the Cimzia(TM) (certolizumab pegol, CDP 870) (3 events) and placebo (2 events) treatment groups.
The PRECiSE clinical trial program is composed of four studies (PRECiSE 1, 2, 3 and 4). In addition to PRECiSE 2, the detailed results of which were presented at ACG, PRECiSE 1 is a 26-week double-blind, placebo-controlled trial, and represents the first long-term fully placebo-controlled clinical trial of a biologic in Crohn's disease. PRECiSE 1 successfully met its primary endpoints with statistical significance. As expected from a study with such a challenging trial design, top-line results were of lower magnitude than observed in the PRECiSE 2 trial. The detailed analysis of the PRECiSE 1 data is still ongoing, with results planned for presentation at a forthcoming gastroenterology congress. PRECiSE 3 and 4 are both 24-month, open-label trials for patients who participated in either PRECiSE 1 or 2, assessing the longer-term safety and tolerability of Cimzia(TM), and are currently ongoing.
Methods
The 26-week PRECiSE 2 study was designed to assess the safety and efficacy of Cimzia 400 mg for the maintenance of clinical response after open-label induction therapy in patients with mild to moderate Crohn's disease. Those who responded by week six were randomized to receive either a once-monthly maintenance dose of certolizumab 400 mg or placebo. Clinical response was defined as a 100 point drop in the Crohn's Disease Activity Index (CDAI), which measures the disease severity by taking into account a number of factors such as intensity of symptoms, medication and general well-being. The primary endpoint was the percentage of patients at week 26 with a C-reactive protein (CRP, a marker of inflammation) level greater than or equal to 10 mg who maintained a clinical response after successful induction. Major secondary endpoints included remission (CDAI less than or equal to 150) in those with a CRP level greater than or equal to 10mg, and response and remission in the overall treatment population.
About Crohn's Disease
Crohn's disease is a chronic disorder that causes inflammation of the gastrointestinal tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). Common symptoms include diarrhea, fever, abdominal pain and weight loss. Although it can occur at any age, it primarily impacts young adults between the ages of 15 and 35. Because it is a chronic illness, patients experience an ongoing cycle of symptom "flare-ups" and periods of remission, when symptoms disappear or are controlled.(1) This cycle can impact all aspects of a patient's life, including their pursuit of higher education and relationships with employers, friends and family members.(3)
About Cimzia(TM)
Cimzia(TM) is unique anti-TNF therapy in that it is a humanized antibody Fab' fragment chemically attached to polyethylene glycol (PEG, i.e. PEGylated). PEGylation increases the plasma half-life of certolizumab to approximately two weeks.
About UCB
UCB (http://www.ucb-group.com/) is a global biopharmaceutical leader dedicated to the research, development and commercialization of innovative products in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders and oncology. UCB employs over 8,500 people operating in over 40 countries, and achieved revenues of 2.1 billion euros (including net turnover, royalties, and fees) in 2004. UCB is listed on the Euronext Brussels with a market capitalization of approximately 5.5 billion euros. Worldwide headquarters are located in Brussels, Belgium.
UCB Pharma, Inc. is the North American subsidiary of UCB, with U.S. headquarters located in Smyrna, Georgia. UCB's key products in the U.S. are Keppra(R) (levetiracetam), Zyrtec(R)+ (cetirizine HCl), Tussionex(R) CIII
(hydrocodone polistirex/chlorpheniramine polistirex), and Metadate CD(TM) CII (methylphenidate HCl, USP).
+ Zyrtec is licensed to and co-promoted with Pfizer, Inc. in the United States. (1) Crohn's and Colitis Foundation of America. Disease Information page: http://www.ccfa.org/info/about/crohns. Accessed October 3, 2005. (2) European Federation of Crohn's & Ulcerative Colitis Associations. Newsletter, pg. 30, May 2005 (http://www.efcca.org/efcca_nl22.pdf). (3) Crohn's and Colitis Foundation of America and the Digestive Disease National Coalition. Voices of Crohn's Survey: http://www.crohnsresource.com/voices/key_findings.html. Accessed September 22, 2005.
UCB Pharmaceuticals Inc.
CONTACT: Lisa B. Garman, Head, U.S. Communications & Public Relations,Mobile, +1-404-291-4772, or Susan Thiele, Ketchum Public Relations,+1-646-935-4133, susan.thiele@ketchum.com; or Investor Relations -Jean-Christophe Donck, Vice President, Corporate Communication & InvestorRelations, +32-2-559-9588, Fax +32-2-559-9571, JC.Donck@UCB-Group.com
Web Site: http://www.ucb-group.com/http://www.ccfa.org/info/...ey_findings.html
Source: PRNewswire
Posted on: Monday, 31 October 2005, 09:00 CST
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FDA Accepts ERBITUX(R) (Cetuximab) sBLA Submission for the Treatment of Squamous Cell Carcinoma of the Head and Neck and Grants Priority Review
ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has notified ImClone Systems that it has accepted for filing the Company's supplemental Biologics License Application (sBLA) for ERBITUX(R) (Cetuximab), an IgG1 monoclonal antibody, in the treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN). The application seeks approval for use of ERBITUX in combination with radiation for locally or regionally advanced head and neck cancer, and as monotherapy in patients with recurrent and/or metastatic disease where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate.
The Companies also announced that the ERBITUX sBLA has been granted priority review. The FDA grants priority review to biologics that potentially offer a significant therapeutic advance over existing therapies for serious or life-threatening diseases. Based on the priority review designation, the FDA has six months from the submission date of August 30, 2005, to take action on the sBLA filing.
About Head and Neck Cancer
According to the American Cancer Society, approximately 40,000 Americans will be diagnosed with head and neck cancer this year, including cancers of the tongue, mouth, pharynx, and larynx. In addition, it is estimated that more than 11,000 will die from the disease in 2005 in the U.S.
About ERBITUX(R) (Cetuximab)
On February 12, 2004, the FDA approved ERBITUX for use in the United States in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. The effectiveness of ERBITUX for the treatment of colorectal cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX in metastatic colorectal cancer patients.
ERBITUX binds specifically to the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha. The EGFR is constitutively expressed in many normal epithelial tissues, including the skin and hair follicle. Over-expression of EGFR is also detected in many human cancers including those of the colon and rectum.
Important Safety Information
Severe infusion reactions, rarely fatal and characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and hypotension, have occurred in approximately 3% (20/774) of patients with the administration of ERBITUX. Most reactions (90%) were associated with the first infusion of ERBITUX despite the use of prophylactic antihistamines. Severe infusion reactions require immediate and permanent discontinuation of ERBITUX therapy. Caution must be exercised with every ERBITUX infusion as there were patients who experienced their first severe infusion reaction during later infusions. A 1-hour observation period is recommended following the ERBITUX infusion. Longer observation periods may be required in patients who experience infusion reactions.
Severe cases of interstitial lung disease (ILD), which was fatal in one case, occurred in less than 0.5% of 774 patients receiving ERBITUX.
Dermatologic toxicities, including acneform rash (11% of 774 patients, grade 3/4), skin drying and fissuring, inflammatory or infectious sequelae (e.g., blepharitis, cheilitis, cellulitis, cyst) and paronychial inflammation (0.4% of 774 patients, grade 3) were reported. Sun exposure may exacerbate any skin reactions.
Hypomagnesemia has been reported with ERBITUX when administered as a single agent and in combination with multiple different chemotherapeutic regimens. The incidence of hypomagnesemia (both overall and severe (NCI CTC grades 3 & 4)) was increased in patients receiving ERBITUX alone or in combination with chemotherapy as compared to those receiving best supportive care or chemotherapy alone based on ongoing, controlled clinical trials in 244 patients. Approximately one-half of these patients receiving ERBITUX experienced hypomagnesemia and 10-15% experienced severe hypomagnesemia. Electrolyte repletion was necessary in some patients, and in severe cases, intravenous replacement was required. Patients receiving ERBITUX therapy should be periodically monitored for hypomagnesemia, and accompanying hypocalcemia and hypokalemia during, and up to 8 weeks following the completion of, ERBITUX therapy.
Other serious adverse events associated with ERBITUX in clinical trials (n=774) were fever (5%), sepsis (3%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% in patients receiving ERBITUX plus irinotecan, 2% receiving ERBITUX as a single agent) and diarrhea (6% in patients receiving ERBITUX plus irinotecan, 0.2% with ERBITUX as a single agent).
Additional common adverse events seen in patients receiving ERBITUX plus irinotecan (n=354) or ERBITUX as a single agent (n=420) were acneform rash (88%/90%), asthenia/malaise (73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain (45%/26%), vomiting (41%/25%), fever (34%/27%), constipation (30%/26%) and headache (14%/26%).
Full prescribing information, including boxed WARNING regarding infusion reactions, is available upon request or by visiting www.Erbitux.com.
About ImClone Systems
ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments, designed to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.
Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
About Bristol-Myers Squibb
Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive exploration of innovative cancer fighting therapies that extend and enhance the lives of patients living with cancer. More than 40 years ago, Bristol-Myers Squibb built a unified vision for the future of cancer treatment. With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anti-cancer therapies that are an important cornerstone of care today. Hundreds of scientists at Bristol-Myers Squibb's Pharmaceutical Research Institute are studying ways to improve current cancer treatments and identify better, more effective medicines for the future.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that ERBITUX will receive regulatory approval for the treatment of SCCHN, or, if approved, will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2004 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Source: Business Wire
bizjournals.com
MedImmune files to test lupus drug in humans
Friday October 14, 3:07 pm ET
MedImmune and its New Jersey partner have filed with federal regulators to begin human testing on a drug for treating lupus and potentially other autoimmune disorders.
In November 2004, Gaithersburg-based MedImmune (NASDAQ: MEDI - News) and Princeton-based Medarex (NASDAQ: MEDX - News) formed a collaboration to develop antibody drugs targeting interferon-alpha.
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Preclinical data indicate that levels of interferon-alpha are elevated in many patients with lupus or other autoimmune disorders. The drug, called MEDI-545, binds to interferon-alpha and has been shown to neutralize its activity in preclinical studies.
To begin Phase I human tests on the lupus drug, MedImmune and Medarex filed an investigational new drug application with the Food and Drug Administration. Once that application is approved, the biotechnology companies begin the long, and costly, process of taking a product candidate through the development cycle.
Under the terms of their agreement, MedImmune currently has full responsibility for all ongoing development activities on the lupus drug.
The filing, says MedImmune Senior Director of Research of Anthony Coyle, "reflects MedImmune's commitment to the development of new treatments targeting inflammatory and autoimmune diseases and marks another milestone in our efforts to advance our pipeline of product candidates."
The Lupus Foundation of America estimates about 1.5 million people in the United States suffer from some form of lupus, which is a chronic inflammatory disease that causes the body to attack its own tissue and organs, including the skin, joints, blood and kidneys.
MedImmune has local competition in the race to bring new lupus drugs to market.
Rockville-based Human Genome Sciences (NASDAQ: HGSI - News) on Oct. 5 reported that a midstage clinical trial found its lupus drug to be safe and well tolerated, but the drug did not meet its primary efficacy goals. That news caused stock in Human Genome Sciences to fall about 30 percent.
Published October 14, 2005 by the Washington Business Journal
PR Newswire
Neue europäische Studie zum Einsatz von Cetuximab als adjuvante Therapie bei kolorektalem Karzinom
Montag 31. Oktober 2005, 09:04 Uhr
PARIS, Frankreich, October 31 /PRNewswire/ --
- 13. Annual European Conference on Clinical Oncology
In einer grossen europaweiten Zusammenarbeit wird ab heute untersucht,
ob Cetuximab in Kombination mit Oxaliplatin-haltiger Chemotherapie (FOLFOX-
4) bei völliger Resektion im Erkrankungsstadium III nach der Operation die
Anzahl der Krankheitsrückfälle reduziert und die Überlebenszeit verlängert.
Wissenschaftler der Fédération Francophone de Cancérologie Digestive (FFCD)
leiten diese Intergroup-Studie in Zusammenarbeit mit der European
Organisation for Research and Treatment ANZEIGE
of Cancer (EORTC) sowie mit den
nationalen Gruppen, die an den europaweiten Studien zur Krebsstruktur im
Verdauungskanal (PETACC) beteiligt sind. Diese von der FFCD finanzierte
Studie wird 2.000 Patienten rekrutieren und soll vor Ende dieses Jahres
beginnen.
Circa 25 Prozent der 370.000 Patienten in Europa, die jedes Jahr mit
kolorektalem Karzinom diagnostiziert werden, befinden sich im
Erkrankungsstadium III.(1,2) In diesem Stadium hat der Tumor bereits
begonnen, sich durch die Darmwand und in die angrenzenden Lymphknoten
auszuweiten. Eine Operation mit nachfolgender Chemotherapie hat die
Überlebenszeit zwar signifikant verbessert, jedoch werden etwa ein Drittel
der Patienten aller Wahrscheinlichkeit nach innerhalb der nächsten drei
Jahre einen Krankheitsrückfall erleiden. (3) Daher ist es wichtig, dass
neue Therapien untersucht werden, welche die Rückfallrate mindern und die
Überlebenszeit verbessern.
In der PETACC-8-Studie werden Patienten mit völlig resektiertem
kolorektalen Karzinom im Erkrankungsstadium III randomisiert ausgewählt und
erhalten entweder Cetuximab in Kombination mit FOLFOX-4 oder FOLFOX-4
alleine. Die Therapien werden für die Dauer von 6 Monaten durchgeführt.
Etwa 340 führende Zentren in ganz Europa, einschliesslich Frankreich,
Deutschland, Belgien, Spanien, Grossbritannien, Österreich, Italien,
Dänemark, Portugal, Schweden und andere Länder, werden Patienten
rekrutieren. Weitere Informationen erhalten Sie von
Martina Schneider, PETACC-8-Projektmanager (+33-3-80-39-34-83,
Martina.Schneider@u-bourgogne.fr).
"Mehr und mehr Menschen entwickeln kolorektales Karzinom und mindestens
30 Prozent der Patienten mit völliger Resektion im Erkrankungsstadium III
werden rückfällig. Daher müssen wir die Chancen der Patienten durch die
Aufnahme neuer gezielter Therapien in unsere Behandlungsstrategien
verbessern", sagte der leitende Prüfarzt der Studie, Dr. Julien Taïeb vom
Groupe Hospitalier Pitié Salpêtrière, Paris. "Wir hoffen sehr, dass die
Kombination Cetuximab und FOLFOX, die sich bereits bei Patienten im
fortgeschrittenen Erkrankungsstadium als wirksam erwies, auch die
krankheitsfreie Überlebenszeit nach der Operation signifikant verbessern
wird."
Cetuximab zielt speziell auf den epidermalen Wachstumsfaktorrezeptor
(EGFR) ab, der oft in Krebszellen vorhanden ist. Durch Blockieren des EGFR
wird verhindert, dass der Tumor weiter wächst und die Krebszellen sich auf
andere Organe im Körper ausweiten. Cetuximab hat auch eine verbesserte
Wirkung von Strahlen- und Chemotherapie gezeigt.
Die am häufigsten verschriebene adjuvante Chemotherapie (nach der
Operation) ist seit geraumer Zeit 5-Fluorouracil/Leucovorin (5-FU/LV).
Oxaliplatin ist eine neue Generation von Chemotherapie, die in Kombination
mit 5-FU/LV die dreijährige krankheitsfreie Überlebensrate im
Erkrankungsstadium III von 65,3 Prozent (5-FU/LV allein) auf 72,2 Prozent
(Oxaliplatin und 5-FU/LV; FOLFOX) erhöhen konnte.(3) Cetuximab zeigte
konsistent hohe Responseraten und längere progressionsfreie
Überlebenszeiten, wenn es in den späteren Stadien von kolorektalem Karzinom
verwendet wurde,(4) und es wird erwartet, das Oxaliplatin das Wachstum und
die Ausbreitung von Krebszellen in den früheren Erkrankungsstadien, in
denen die Chance für eine Heilung noch grösser ist, wirksam verhindert.
Daher erwarten die Prüfärzte, dass die zusätzliche Verabreichung von
Cetuximab einen Meilenstein bei der Heilung von noch mehr Patienten
darstellen wird, ohne deren Sicherheit zu kompromittieren.
Hinweise an die Redakteure:
Über PETACC (Pan-European Trials in Alimentary Tract Cancer)
Umfangreiche klinische Studien sind erforderlich, um die signifikanten
Vorteile einer neuen adjuvanten Chemotherapie für die Behandlung von
Darmkrebs aufzuzeigen. In Anbetracht der grossen Anzahl an Patienten, die
rekrutiert werden sollen, haben sich mehrere Kooperationsgruppen unter dem
Namen PETACC zusammengeschlossen. Dieses Konsortium besteht aus über einem
Dutzend europäischer nationaler und internationer Kooperationsgruppen. Jede
Gruppe kann Projekte vorschlagen, die dann von der PETACC-
Generalversammlung diskutiert und genehmigt werden. Der betriebliche Teil
der PETACC-Studien ist aus Gründen der Einheitlichkeit zentralisiert
(Verfahren, Qualitätssicherung usw.), aber jede Gruppe behält ihre
Individualität innerhalb des allgemeinen Rahmens bei.
Über die FFCD
Die Fédération Francophone de Cancérologie Digestive (FFCD) ist ein
französischer Akademikerverband, der 1991 von Fachpersonal für
Krebserkrankungen im Verdauungstrakt (Gastroenterologen, Onkologen,
Radiologen, Chirurgen, Pathologen usw.) gegründet wurde.
Zu den Forschungstätigkeiten zählen hauptsächlich das Design neuer
klinischer Studien durch das wissenschaftliche Kommitee der FFCD, die
Durchführung von klinischen Phase-II- und Phase-III-Studien sowie die
Errichtung eines biologischen Forschungszentrums für Translational Research
(Umsetzung von Erkenntnissen aus dem Labor zum Krankenbett).
Die FFCD ist der rechtliche Sponsor der PETACC-8-Studie.
Über kolorektales Karzinom
Das kolorektale Karzinom ist die dritthäufigste bösartige
Krebserkrankung weltweit.(5) Allein in Europa erkrankten im Jahr 2002 mehr
als 370.000 Menschen an diesem Leiden, was für 12 Prozent aller
Krebskranken und ca. 200.000 Tote verantwortlich war.(1)
Quellenhinweise:
1. Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and
Prevalence Worldwide IARC Cancer Base No. 5. Version 2.0, IARC Press, Lyon,
2004
2. Effective Health Care, NHS Center for Reviews and Dissemination,
University of York 1997; 3: ISSN: 0965-0288.
3. Andre T et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant
treatment for colon cancer. N Engl J Med 2004 Jun 3; 350 (23):2343-51.
4. Cunningham D et al. Cetuximab monotherapy and cetuximab plus
irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J
Med 2004; 22; 351(4): 337-45.
5. Parkin DM et al. Estimating the world cancer burden. GLOBOCAN 2000.
Int J Cancer 2001; 94(2): 153-156.
Federation Francophone de Cancerologie Digestive (FFCD)
http://www.rednova.com/news/health/289680/...dex.html?source=r_health
Dendreon's Second Randomized Phase 3 D9902A Trial of PROVENGE Extends Survival in Patients With Advanced Prostate Cancer
PARIS, Oct. 31 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that final results of its second Phase 3 study (D9902A) of PROVENGE(R) (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of prostate cancer, were presented here today during a late-breaking clinical trials session at ECCO 13-the European Cancer Conference. Researchers concluded that these results are consistent with the results from the Company's first Phase 3 study (D9901). The Company recently announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market PROVENGE based on discussions of these data with the FDA.
"The combined data from the trials of PROVENGE versus placebo demonstrate that active immunotherapy favorably impacts survival in men with asymptomatic, metastatic, androgen-independent prostate cancer," reported Celestia S. Higano, M.D., director and associate professor of the Genitourinary Oncology Clinical Research Group at the University of Washington, Seattle, who presented the data. "Given the favorable side effect profile, PROVENGE may provide a useful alternative for men prior to initiating chemotherapy."
Summary of PROVENGE Studies Study 1 Study 2 Studies 1 and 2 (D9901) (D9902A) Integrated N = 127 N = 98 N = 225 Median Survival in months: PROVENGE 25.9 19.0 23.2 Placebo 21.4 15.7 18.9 Median Survival Benefit: % (months) 21% (4.5) 21% (3.3) 23% (4.3) Hazard Ratio 1.7 1.3 1.5 p-value (log rank) p=0.010 p=0.331 p=0.011 Hazard Ratio 2.1 1.9 1.8 p-value (Cox regression, adj.) p=0.002 p=0.023 p=0.0006 36-Month Survival: % (patients) PROVENGE 34% (28) 32% (21) 33% (49) Placebo 11% (5) 21% (7) 15% (12) Study Results
In the D9902A study, the three-year final survival analysis in the intent- to-treat population of the double-blind, placebo-controlled study of PROVENGE in 98 men with asymptomatic, metastatic, androgen-independent (hormone- refractory) prostate cancer showed those patients who received PROVENGE had a 19.0 month median survival time compared with only 15.7 months for the patients who were randomized to receive a placebo. This represents a 3.3 month or 21 percent improvement in median survival for patients who were randomized to receive PROVENGE compared to placebo (p-value = 0.331, log-rank; HR = 1.3). This hazard ratio implies that patients receiving placebo have a relative risk of dying that is 30 percent higher than those patients receiving PROVENGE. A Cox multivariate regression analysis of overall survival, which adjusts for imbalances in prognostic factors known to influence survival, met the criteria for statistical significance (p-value = 0.023; adjusted HR = 1.9). The hazard ratio observed in this analysis was consistent with that seen in the Company's first Phase 3 study, D9901. In addition, at the three- year final follow up, 32 percent of the men in the PROVENGE group were alive compared to only 21 percent of the men in the placebo group, a 52 percent improvement in the survival rate.
As in previous studies, PROVENGE was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.
As reported earlier this year, the final three-year follow up of the D9901 study of PROVENGE in 127 men with asymptomatic, metastatic, androgen- independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.010; HR = 1.7). In addition, a Cox multivariate regression analysis was used to test the validity of the survival benefit seen in this study. The results showed that patients receiving placebo had a relative risk of dying that is more than twice as high as those patients receiving PROVENGE (p-value = 0.002; adjusted HR = 2.1).
Dr. Higano also presented an integrated analysis of the data from studies D9901 and D9902A, which showed a statistically significant survival benefit in the overall intent-to-treat population of 225 patients. In this analysis, patients receiving PROVENGE had a median survival of 23.2 months compared to 18.9 months for patients in the placebo group, a 4.3 month or 23 percent improvement in median survival. This analysis was statistically significant by both log rank (p-value = 0.011; HR = 1.5) and Cox multivariate regression analysis of overall survival (p-value = 0.0006; adjusted HR = 1.8). In addition, at the three-year final follow up, 33 percent of the men who received PROVENGE were alive compared to only 15 percent of the men who received placebo, a greater than 100 percent improvement.
"We were pleased to see a statistically consistent and meaningful survival benefit across the three analyses," said Robert M. Hershberg, M.D., Ph.D., Dendreon's chief medical officer. "We will be working closely with the FDA to complete our BLA and to bring PROVENGE to market for men with advanced stage prostate cancer who currently have few appealing treatment options available to them."
Conference Call Details
LIVE Access on October 31, 2005, 17:30 Paris time; 11:30 a.m. ET; 8:30 a.m. PT:
-- Phone 877-502-9274 (domestic) or +1-913-981-5584 (international) -- Webcast connection through the Dendreon website at http://www.dendreon.com/ in the Investors/Webcast section. REPLAY Access: -- Phone replay available at 2:00 p.m. ET for 3 days by calling 888-203-1112 (domestic) or +1-719-457-0820 (international); Passcode: 6720485 -- Webcast replay will be available for 90 days from the Dendreon website at http://www.dendreon.com/ in the Investors/Webcast section. About Prostate Cancer
More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease. Prostate cancer is the most commonly diagnosed non-skin cancer in the United States and the third most common cancer worldwide.
About PROVENGE (sipuleucel-T)
The generic name "sipuleucel-T" has been approved by the United States Adopted Names (USAN) Council for Dendreon's investigational active cellular immunotherapy (ACI) for prostate cancer, previously known as APC8015. If approved, sipuleucel-T will be marketed as PROVENGE.
PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95% of prostate cancers. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit http://www.dendreon.com/.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, including collaborators, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov/.
Dendreon Corporation
CONTACT: Monique M. Greer, Sr. Director, Corporate Communications ofDendreon Corporation, 206-829-1500
Web site: http://www.dendreon.com/
Source: PRNewswire-FirstCall
Phase III MabThera maintenance trial in lymphoma shows positive results earlier than expected
Category: Lymphoma/Leukemia News
Article Date: 31 Oct 2005
Roche has been informed by the European Organisation for Research and Treatment of Cancer (EORTC) that a phase III study[1] in relapsed indolent non-Hodgkin's lymphoma (NHL) evaluating the use of MabThera (rituximab) as maintenance treatment has shown positive results earlier than expected. MabThera maintenance therapy is administered over two years and aims to prevent disease recurrence.
“Our study confirms that MabThera maintenance therapy is beneficial for patients that have already received MabThera as part of their initial therapy” said lead investigator, Professor Marinus van Oers M.D., from the Academic Medical Center of the University of Amsterdam. “The full results of the trial will be presented as an oral presentation at this year's annual conference of the American Society of Hematology (ASH) in Atlanta.”
Non-Hodgkin's lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system.
“We look forward to the presentation of the full trial results in December“, said Eduard Holdener, Head of Pharma Development at Roche. “Based on this new information MabThera maintenance therapy could well become the new standard treatment in this disease.”
Roche is currently preparing an application to the European Authorities to request a label extension for maintenance therapy, expected to be submitted in the fourth quarter 2005, making this treatment option available to all patients.
About the study
The international cooperative group phase III trial was conducted in 18 countries and recruited 465 patients with relapsed indolent NHL. Patients were randomized to receive either six cycles of MabThera in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy, or CHOP chemotherapy alone. Patients who responded to initial treatment were then randomised to MabThera maintenance therapy (one infusion every three months for two years) or no further treatment.
A pre-planned analysis in early 2004 showed that induction treatment with MabThera plus CHOP was significantly superior to CHOP alone and that two years of MabThera maintenance therapy substantially improved progression-free survival compared to observation. Therefore, the trial was suspended as it had reached both primary endpoints. At that time the results were not mature enough to determine if MabThera maintenance therapy also prolongs progression-free survival for the subgroup of patients who already had received MabThera plus CHOP as initial treatment. The EORTC therefore originally decided to amend the study to evaluate this outstanding question.
An updated analysis of the study data with additional follow-up of approximately 18 months has now demonstrated a significant benefit of MabThera maintenance therapy for patients who initially received MabThera plus CHOP. Consequently, the EORTC, following the recommendation by the Independent Data Monitoring Committee, has stopped the study and decided to report the results at the ASH meeting in December.
About MabThera
MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
MabThera was initially indicated as a single-agent treatment for relapsed or refractory indolent NHL, and received European approval in March 2002 for the treatment of aggressive NHL in combination with CHOP chemotherapy. In August of 2004 MabThera received European approval for first line treatment of Indolent NHL in combination with CVP chemotherapy. MabThera is known as Rituxan in the United States, Japan and Canada. More than 700,000 patients have been treated with MabThera worldwide to date.
Genentech and Biogen Idec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (http://www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Further Information:
- About Roche in Oncology
- About Genentech
- About BiogenIdec
- About cancer
- About Lymphoma
[1] European Organization for Research and Treatment of Cancer (EORTC) Study 20981
basel.mediaoffice@roche.com
Multi-million dollar deal to benefit medical research
Category: Biology/Biochemistry News
Article Date: 29 Oct 2005
The drug, HUMIRA®, is so far used to treat rheumatoid arthritis but has other applications in the pipeline. The Scripps Research Institute and the American company, Stratagene will share US$64m as part of the agreement.
The technology, developed by the MRC Laboratory of Molecular Biology, was the basis for the setting up of Cambridge Antibody Technology Ltd in 1990 as a business.
The American pharmaceutical company, Abbott has agreed to pay (via Cambridge Antibody Technology) US$255 million in place of the future royalties the MRC, Scripps Research and Stratagene would have received on sales of HUMIRA®. In addition, Cambridge Antibody Technology will pay the MRC a further US$7.5m over five years from 2006, providing that HUMIRA® remains on the market.
The MRC patents cover a series of inventions made by Sir Gregory Winter and his colleagues at the MRC Laboratory of Molecular Biology during the late 1980s and early 1990s for making 'human monoclonal antibodies'.
Sir Gregory commented "Our inventions originated from pure curiosity-driven and long-term basic research funded at the Laboratory of Molecular Biology by the MRC. Provided such research is intelligently and quickly exploited, it can pay handsome dividends for medicine, UK industry and human health. It can also generate considerable royalty income, which ploughed back into science will help generate the medicines and industries of the future."
Professor Colin Blakemore, the MRC Chief Executive added "This deal is great news for British science. It shows the wonderful achievements that can be won for human health when the Medical Research Council works with industry. It also gives the UK an opportunity to reap the rewards from our past discoveries to make the fullest possible investment in future science. The agreement will help us give our scientists new research facilities and the best laboratories. We also want to invest in initiatives which will help us to translate cutting-edge scientific research into healthcare for all".
The related Scripps Research patents cover inventions which hailed from the laboratory of Dr. Richard A. Lerner, president of the Institute. Dr. Lerner said, "It is wonderful to see the work from our two laboratories come together to benefit so many patients suffering from a variety of serious conditions."
Although the scientists from MRC and Scripps Research were scientific competitors in earlier years, they pooled their inventions in Cambridge Antibody Technology to facilitate exploitation of the technology for creation of new medicines.
Monoclonal Antibodies. These are often referred to as 'magic bullets'. They are custom-made protein molecules that have been designed to home in on specific targets. Dr César Milstein and Dr George Köhler discovered how to make monoclonal antibodies at the MRC Laboratory of Molecular Biology in Cambridge. Their work earned them the Nobel prize in Physiology or Medicine in 1984. It has led to therapeutic products for breast cancer, leukaemia, asthma and transplant rejection; many more are in late stage clinical trials.
HUMIRA® is the first fully human monoclonal antibody to be approved by the American Food and Drug Administration and was developed using combinatorial antibody libraries, on which the founding of Cambridge Antibody Technology was based. It is currently approved only for treatment of rheumatoid arthritis, but it is also in clinical trials for use in other indications including Phase III trials for use in juvenile rheumatoid arthritis, Crohn's disease, psoriatic arthritis and ankylosing spondylitis.
The Medical Research Council (MRC) is a national organization funded by the UK tax-payer. Its business is medical research aimed at improving human health; everyone stands to benefit from the outputs. The research it supports and the scientists it trains meet the needs of the health services, the pharmaceutical and other health-related industries and the academic world. MRC has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. About half of the MRC's expenditure of approximately £500 million is invested in its 40 Institutes, Units and Centres. The remaining half goes in the form of grant support and training awards to individuals and teams in universities and medical schools. Web site at: http://www.mrc.ac.uk
Keith McKeown
kmckeown@scripps.edu
Scripps Research Institute
http://www.scripps.edu
Presseschau dazu
http://biz.yahoo.com/ap/051103/amgen_colon_cancer.html?.v=3
AP
Amgen: Cancer Therapy Slows Tumor Growth
Thursday November 3, 2:50 pm ET
By Heidi Vogt, AP Business Writer
Amgen Says Its Experimental Colon Cancer Therapy Slowed Tumor Growth in Late-Stage Study
NEW YORK (AP) -- Biotech drug maker Amgen Inc. said Thursday that its experimental colon cancer therapy, a potential rival to ImClone Inc.'s Erbitux, significantly slowed tumor growth in a late-stage study.
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Amgen shares rose $3.33, or 4.5 percent, to $77.23 in afternoon trading on the Nasdaq while shares of Abgenix Inc., its partner in the drug, jumped $3.73, or 40 percent to $13.10. Shares of New York-based ImClone dove $7.39, or 20 percent, to $28.72.
Amgen said tumors grew 46 percent more slowly in patients taking its Panitumumab drug than in those who received palliative care -- a standard that can include a number of treatments but did not include chemotherapy drugs in this study. The 463-patient trial consisted of patients with colon cancer that had spread and who had failed standard chemotherapy.
The results exceeded the company's target for a 33 percent decrease in tumor growth.
Thousand Oaks, Calif.-based Amgen said the study results mean its drug is the first of its class to improve the likelihood that patients will live without their disease getting worse. ImClone's Erbitux approval is based on a different measure -- tumor shrinkage. Amgen said its drug also decreased tumor size, a measure it had set as a secondary endpoint, and that those results were comparable with mid-stage trials.
Panitumumab and Erbitux work in generally the same way, by binding to a protein that is associated with tumor growth. However, Panitumumab is derived solely from human antibodies, while Erbitux is partly made up of mouse antibodies.
"The benefit with a fully human antibody is that a human's body is less likely to reject it," said Citigroup analyst Elise Wong. "With Panitumumab you have very low infusion reactions and very low rates hypersensitivity."
Though she cautioned that the broad top-line data make firm conclusions difficult, Wong said the results appear "very robust," adding that "it should prove to be a very competitive product to Erbitux" if just based on the safety advantage and its less-frequent dosing regimen (every other week versus once a week).
Wong also noted that Amgen's study group consisted of patients that had more advanced cancer than those that Erbitux used to gain its approval last February.
Merrill Lynch analyst Eric Ende had said that ImClone shares would be worth between $28 and $31 if the Amgen trial met its endpoint, arguing that a positive study result could lead to Panitumumab dominating the colon cancer market despite Erbitux's head start.
Amgen said it plans to start the process of applying for approval from the Food and Drug Administration by the end of the year with the aim of completing its submission in the first quarter of 2006.
Abgenix of Fremont, Calif., helped develop panitumumab with its animal research technology -- a method of genetically engineering mice for use in creating antibody therapies. The company stands to get a share of the drug's profits if it is approved.
Panitumumab is also in clinical trials for lung and kidney cancer, while ImClone is investigating Erbitux for head and neck cancer.
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http://www.marketwatch.com/news/yhoo/...456A%2DA3AD%2DC4D0ED803767%7D
Abgenix, Amgen rally on drug news
Therapy seen as potential rival to ImClone's Erbitux
By Val Brickates Kennedy, MarketWatch
Last Update: 5:02 PM ET Nov. 3, 2005
Disable MW live quotes | E-mail it | Print | Alert | Reprint |
BOSTON (MarketWatch) -- Shares of Abgenix Inc. jumped Thursday, while Amgen Inc. scored more modest gains, as they said that a drug they've been developing has been shown to be highly effective in slowing the progression of advanced colorectal cancer.
ABGXABGX, , ) rocketed 38% to close at $12.90, while Amgen shot up 5% to $77.51.
Amgen and Abgenix announced that patients in a Phase III clinical trial who took the drug panitumumab, an antibody-based therapy, had a 46% decrease in the progression of their cancerous tumors as opposed to those who didn't receive the therapy.
The companies tested the drug in 463 patients with advanced colorectal cancer who had already failed standard chemotherapy treatment.
Amgen and Abgenix said they hope to finish filing for regulatory approval of panitumumab during the first quarter of 2006.
Shares of rival ImClone Systems (IMCL:
sank on the news, dropping as much as 19%. Imclone and partner Bristol-Myers Squibb (BMY: BMY
market Erbitux as an antibody-based colorectal cancer drug.
ImClone shares had been on a roll in recent days after it announced it had filed to have Erbitux approved for the treatment of head and neck cancers. Erbitux is currently ImClone's only drug on the market.
Dieses posting hänge ich beispielhaft an Abgenix....
Grüße
ecki
Optionen
| Boardmail an "ecki" |
Wertpapier: Medarex |
Info- und Nachrichtenseiten Biotech - Antikörper
(Linksammlung wird laufend erweitert und nach einiger Zeit wieder reingestellt)
Übersichtstabellen Aktivitäten therapeutische Antikörper /Unternehmen/Partnerschaften (4 Tabellenseiten)
Online Magazin Nature Focus Antibody Engineering and Manufacture / Zahlreiche Artikel zum Thema:
Guter Einstiegs/Übersichtsartikel:
hier
Infoseite:
Lamerie
News zur Technologie im pdf-format zum Download
Newszu Therapie im pdf Format zum Download
US-Infoseite ->Auf health gehen
Allgemeines rund um Ak-Therapien (leicht zu lesen):
Darmkrebs 1
Darmkrebs 2
Warum Antikörper?
Technologie Hintergrund der Morphosys Technik: Antikörper ohne Tiere (sog. humane AK's)
Diashow
Homepages einiger Firmen, die therapeutische Antikörper herstellen und Ak-Medikamenten in der Pipeline haben.
Die Firmenseiten enthalten zum Teil auch Basisinfos über Antikörper und Beschreibungen spezieller Technologien zur Herstellung.
Europa: Homepages
Morphosys
Micromet
Genmab
Cambridge Antibody (CAT)
Cytos
Biotest
Allgemeines zu Antikörpern v. der Biotest HP :
Autoimmunerkrankungen
Antikörper
Aktivitäten zu therapeutischen - Aks (Pipeline inbes. AK zu Rheum. Arthritis ) von Biotest sind in PDF-Files (Rede zur HV, Herbstkonferenz) hier dargestellt:
hier
USA
Medarex Homepage (MEDX)
Finanzporträt + News MEDX
Abgenix HP (ABGX)
Finanzporträt ABGX
HP Protein Design Labs (PDLI)
Finanzporträt + News PDLI
Finanzporträt + News PDLI
Web Site: HP Human Genome Sciences (HGSI)
Finanzporträt + News HGSI
Lupus Medikament Studienziel nicht erreicht
Abbott HP (ABT News zu Humira)
Eli Lilly (LLY, Reopro)
Roche Pipeline zu Alzheimer
(Diskussionen zu den Werten im finance-yahoo message board)
Firmen (teilweise nur in den Links erwähnt)
Roche Novartis Schering Pfizer Eli Lilly Abgenix Protein Design Medarex Genmab Morphosys Micromet Biotest
Cambridge Antibody Genmab
dpa-afx
Hugin-News: GPC Biotech AG
Mittwoch 9. November 2005, 09:31 Uhr
Deutsche Zulassungsbehörde erteilt GPC Biotech (Xetra: 585150 - Nachrichten) die Genehmigung den monoklonalen Krebs-Antikörper 1D09C3 in zusätzlicher klinischer Phase-1-Studie zu testen
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin. Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
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Martinsried/München und U.S.-Forschungs- und Entwicklungsstandorte in Waltham/Boston, Mass., und Princeton, N.J., 9. November ANZEIGE
2005 - Die GPC Biotech AG (Frankfurt: GPC; TecDAX 30; NASDAQ (NASDAQ: Nachrichten) : GPCB) gab heute bekannt, dass das Paul-Ehrlich-Institut (PEI) die Genehmigung erteilt hat, in Deutschland die klinischen Studien im Menschen mit dem monoklonalen Krebsantikörper 1D09C3 zu beginnen. Das PEI ist die deutsche Zulassungsbehörde für biologische und hämatologische Arzneimittel. Die offene Phase-1-Studie untersucht 1D09C3 bei Patienten, die an einem resistenten B-Zell-Tumor leiden oder nach einer zuvor durchgeführten Standardtherapie einen Rückfall erlitten haben. Sie untersucht ein anderes Verabreichungsschema als die bereits in der Schweiz und Italien laufende Phase-1-Studie. Ziel der klinischen Studie ist es, die Sicherheit und Verträglichkeit des Antikörpers bei Patienten zu ermitteln und eine Empfehlung für die Dosierung sowie für das Verabreichungsschema für weiterführende Phase-2-Studien zu geben. Diese zweite Phase-1-Studie wird an der Universitätsklinik Köln durchgeführt und von Prof. Dr. Michael Hallek, Direktor der Abteilung für Innere Medizin, geleitet. Dr. Marcel Rozencweig, Senior Vice President, Drug Development von GPC Biotech, sagte: "Ich freue mich, dass wir die Genehmigung des Paul-Ehrlich-Instituts erhalten haben, mit dieser Studie beginnen zu können. Dies ermöglicht es uns, das Phase-1-Studienprogramm für unseren monoklonalen Krebsantikörper auszuweiten. Wir freuen uns sehr darüber mit Professor Hallek zusammen arbeiten zu können. Er ist ein weltweit anerkannter Experte in der Behandlung von Leukämien und Lymphomen und arbeitet bereits seit mehreren Jahren mit GPC Biotech an der Entwicklung von 1D09C3." Dr. Rozencweig sagte weiter: "Trotz der Fortschritte in der Behandlung von Lymphomen gibt es noch immer einen großen medizinischen Bedarf an Therapien für Patienten, die einen Rückfall erlitten haben oder bereits resistent gegen andere Behandlungen geworden sind. 1D09C3 scheint einen anderen Wirkmechanismus zu haben als die Medikamente, die derzeit gegen Blutkrebs eingesetzt werden. Deshalb hat 1D09C3 das Potenzial zu einer wichtigen neuen Behandlungsmöglichkeit zu werden." Über 1D09C3: 1D09C3 ist ein Anti-MHC (Major Histocompatibility Complex) Klasse II monoklonaler Antikörper. Er bindet an spezifische Zelloberflächenrezeptoren und führt so zum gezielten Absterben aktivierter, sich vermehrender MHC-Klasse-II-positiver Tumorzellen, darunter B-Zell- und T-Zell-Lymphome sowie weitere Blutkrebsarten. Im Jahr 2004 erkrankten schätzungsweise über 54.000 Menschen in den USA und ungefähr 64.000 Menschen in der EU am Non-Hodgkin-Lymphom, der häufigsten Lymphomart. Daten belegen, dass 1D09C3 den programmierten Zelltod auslöst, ohne hierfür ein voll funktionsfähiges Immunsystem zu benötigen. 1D09C3 befindet sich derzeit in einem klinischen Phase-1-Studienprogramm, in welchem der Antikörper in wichtigen europäischen Krebszentren bei Patienten getestet wird, die an einem resistenten B-Zell-Lymphom leiden oder nach einer zuvor durchgeführten Standardtherapie einen Rückfall erlitten haben. Zu den B-Zell-Lymphomen zählen auch die Hodgkin- und Non-Hodgkin Lymphome. GPC Biotech wurde von der europäischen Zulassungsbehörde EMEA für 1D09C3 zur Behandlung von Hodgkin-Lymphom der Orphan-Drug-Status zugesprochen. Weiterführende Informationen zu 1D09C3 sind in der Rubrik "Anti-Krebs-Programme" auf der Webseite des Unternehmens unter www.gpc-biotech.com abrufbar.
Die GPC Biotech AG ist ein biopharmazeutisches Unternehmen, das in der Entdeckung und Entwicklung neuartiger Krebsmedikamente tätig ist. Nach der Durchführung eines "Special Protocol Assessment" bei der U.S.-Zulassungsbehörde FDA und dem Erhalt eines "Scientific Advice" der europäischen Zulassungsbehörde EMEA, befindet sich der am weitesten in der Entwicklung fortgeschrittene Produktkandidat Satraplatin in einer Phase-3-Zulassungsstudie als Zweitlinien-Chemotherapie zur Behandlung von Patienten mit hormonresistentem Prostatakrebs. Die FDA hat Satraplatin für diese Indikation zudem den "Fast-Track-Status" erteilt. GPC Biotech entwickelt außerdem einen monoklonalen Antikörper mit neuartigem Wirkmechanismus gegen verschiedene Blutkrebsarten, der sich derzeit in der klinischen Phase 1 befindet, und betreibt mehrere Medikamentenentdeckungs- und -entwicklungsprogramme im Bereich der Kinase-Hemmer. GPC Biotech hat eine mehrjährige Allianz mit der ALTANA Pharma AG in deren Rahmen GPC Biotech mit dem ALTANA Research Institute in den USA zusammenarbeitet. Diese Allianz bildet für GPC Biotech eine Umsatzbasis bis Mitte 2007. Sitz der GPC Biotech AG ist Martinsried/Planegg. Die U.S.-Tochtergesellschaft, GPC Biotech Inc., hat Forschungs- und Entwicklungseinrichtungen in Waltham/Boston (Massachusetts) und Princeton (New Jersey). Weitere Informationen sind unter http://www.gpc-biotech.com verfügbar.
Diese Pressemitteilung kann Prognosen, Schätzungen und Annahmen über unternehmerische Pläne und Zielsetzungen, Produkte oder Dienstleistungen, zukünftige Ergebnisse oder diesen zugrunde liegende oder darauf bezogene Annahmen enthalten. Jede dieser in die Zukunft gerichteten Angaben unterliegt Risiken und Ungewissheiten, die nicht vorhersehbar sind und außerhalb des Kontrollbereichs der GPC Biotech AG liegen. Viele Faktoren können dazu führen, dass die tatsächlichen Ergebnisse wesentlich von denen abweichen, die in diesen zukunftsgerichteten Angaben enthalten sind. Hierzu zählen insbesondere: der Zeitpunkt und die Auswirkung der Maßnahmen von Behörden, die Ergebnisse klinischer Prüfungen, der relative Erfolg der GPC Biotech AG im Hinblick auf die Entwicklung sowie die Marktakzeptanz jedweder neuer Produkte und die Wirksamkeit des Patentschutzes. Es kann weder gewährleistet werden, dass die SPARC-Studie mit Satraplatin oder die Studie mit 1D09C3 abgeschlossen wird, noch dass diese Medikamente in absehbarer Zeit - wenn überhaupt - die Marktzulassung erhalten. Die Gesellschaft übernimmt keine Verpflichtung dafür, diese in die Zukunft gerichteten Aussagen oder die Faktoren, die sich auf die zukünftigen Ergebnisse, Leistungen oder Erfolge der Gesellschaft auswirken könnten, fortzuschreiben oder an zukünftige Ereignisse anzupassen, selbst wenn in der Zukunft neue Informationen verfügbar werden.
Kontakte: GPC Biotech AG Fraunhoferstr. 20 82152 Martinsried / München Tel./Fax: +49 (0)89 8565-2600/-2610 Martin Brändle (Durchwahl -2693) Associate Director, Investor Relations & Corporate Communications ir@gpc-biotech.com In den USA: Laurie Doyle Associate Director, Investor Relations & Corporate Communications Tel.: +1 781 890 9007 (Durchwahl -267) Fax: +1 781 890 9005 usinvestors@gpc-biotech.com Zusätzlicher Medienkontakt für Europa: Maitland Noonan Russo In London: Brian Hudspith Phone: +44 (0)20 7379 5151 bhudspith@maitland.co.uk --- Ende der Mitteilung --- WKN: 585150; ISIN: DE0005851505; Index: CDAX, MIDCAP, Prime All Share, TecDAX (Xetra: Nachrichten) , HDAX, TECH All Share; Notiert: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in Börse Berlin Bremen, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover, Geregelter Markt in Frankfurter Wertpapierbörse;
http://www.gpc-biotech.com/
Copyright © Hugin ASA 2005. All rights reserved.
http://de.biz.yahoo.com/051109/36/4r9f3.html
dpa-afx
ots news: Genmab A/S / Genmab gibt Ergebnisse für die ersten neun Monate ...
Mittwoch 9. November 2005, 07:51 Uhr
Kopenhagen, Dänemark, November 9 (ots/PRNewswire) - Genmab A/S (CSE: GEN) gab heute die Ergebnisse für den Neumonatszeitraum bis einschliesslich 30. September 2005 bekannt. Für diesen Zeitraum meldete Genmab (Kopenhagen: GEN.CO - Nachrichten) die folgenden Ergebnisse:
- Die Nettoverluste in Höhe von 293 Millionen DKK (ungefähr 47 Millionen USD) entsprachen den Nettoverlusten von 293 Millionen DKK (ungefähr 47 Millionen USD) im selben Zeitraum im Jahr 2004. In den ersten neun Monaten des Jahres 2005 betrug der Nettoverlust pro Aktie ANZEIGE
damit 9,57 DKK (ungefähr 1,54 USD) im Vergleich zu 11,57 DKK (ungefähr 1,87 USD) im entsprechenden Vorjahreszeitraum. - Der Betriebsverlust belief sich auf 323 Millionen DKK (ungefähr 52 Millionen USD). Der Betriebsverlust für den gleichen Zeitraum im Jahr 2004 betrug dagegen 318 Millionen DKK (ungefähr 51 Millionen USD). - Das Nettofinanzeinkommen erreichte eine Gesamthöhe von 30 Millionen DKK (ungefähr 5 Millionen USD) gegenüber einem Nettofinanzeinkommen in Höhe von 25 Millionen DKK (ungefähr 4 Millionen USD) in den ersten neun Monaten im Jahr 2004. - Genmab schloss den Neunmonatszeitraum mit einem Kassenstand von 1,394 Milliarden DKK (ungefähr 225 Millionen USD) ab. Dies entspricht einer Nettosteigerung von 236 Millionen DKK (ungefähr 38 Millionen USD) in den ersten neun Monaten des Jahres 2005. - Die Erlöse in den ersten neun Monaten dieses Jahres beliefen sich auf insgesamt 45 Millionen DKK (ungefähr 7 Millionen USD). Im Vergleichszeitraum des Jahres 2004 wurden dagegen keine Erlöse erwirtschaftet.
Höhepunkte
Im dritten Quartal konnten die folgenden geschäftlichen und wissenschaftlichen Leistungen erzielt werden:
- Einleitung einer zweiten Phase in der Untersuchung von HuMax-CD20 für die Behandlung von Patienten mit chronischem Gelenkrheumatismus (rheumatoide Arthritis/RA), bei denen die Behandlung mit einer oder mehreren DMARD-Mitteln (Disease Modifying Anti-Rheumatic Drugs) versagt hat. - Genmab gewährte Serono (Virt-X: SEO.VX - Nachrichten) im August die exklusiven weltweiten Rechte zur Entwicklung und Kommerzialisierung von HuMax-CD4. Genmab erhielt Lizenzgebühren in Höhe von 20 Millionen USD, und Serono investierte 50 Millionen USD in Stammaktien von Genmab mit 18 % Agio. Die Zahlungen an Genmab einschliesslich aller Meilensteine können sich auf insgesamt 215 Millionen USD belaufen, und Genmab stehen Tantiemen für den weltweiten Verkauf von HuMax-CD4 zu. - Im September wurden positive Zwischenergebnisse für die erste und zweite Phase der HuMax-CD20-Untersuchung bezüglich des Einsatzes bei Patienten mit chronischer Lymphozytenleukämie (CLL) vorgelegt. Bei Patienten, die mit der höchsten Dosis behandelt wurden, konnte eine Reaktionsrate von 52 % beobachtet werden. - Bo Kruse wurde mit Wirkung vom Oktober 2005 zum Vice President, Chief Financial Officer von Genmab ernannt.
Finanzprognose
Genmab überarbeitet derzeit seine Finanzprognose für das Jahr 2005. Aufgrund der verbesserten Betriebseffizienz und günstiger Entwicklungen in den Devisenkursen haben wir unsere Vorhersage für den Kassenstand zum Jahresende 2005 auf ungefähr 1,225 Milliarden DKK revidiert, was einer Steigerung von ungefähr 67 Millionen DKK gegenüber dem Kassenstand zum Jahresende 2004 entspricht.
Zusätzlich haben wir unsere Prognosen für Betriebs- und Nettoverluste angepasst und gehen jetzt davon aus, dass diese Werte ungefähr 440 Millionen DKK bzw. 410 Millionen DKK betragen werden. Wir haben zwar von Serono die gesamten Lizenzgebühren für HuMax-CD4 in Höhe von 20 Millionen USD im dritten Quartal erhalten, haben uns jedoch zu einer konservativen Verbuchung unserer Erlöse entschlossen, die höchsten Buchhaltungsnormen gerecht wird. Aus diesem Grund haben wir die Anrechnung eines Teils dieser Lizenzgebühren verschoben und werden diesen Anteil bis zum Jahresende 2007 linear abschreiben.
Änderungen der Prognosen können vor allem aufgrund der Terminierung und der Vielfältigkeit klinischer Aktivitäten, damit zusammenhängender Kosten und der Schwankungen in den Devisenkursen notwendig werden. Bei den Prognosen wird ausserdem davon ausgegangen, dass im verbleibenden Zeitraum des Jahres 2005 keine weiteren Vereinbarungen getroffen werden, die die Ergebnisse wesentlich beeinflussen könnten.
Konferenzschaltung
Genmab wird morgen, am Mittwoch, den 9. November 2005, eine Telefonkonferenz abhalten, bei der die Ergebnisse des dritten Quartals besprochen werden. Die Konferenzschaltung findet zu folgenden Ortszeiten statt:
15:30 MEZ (mitteleuropäische Zeit) 14:30 WEZ (britische Zeit) 09:30 EST (amerikanische Ostküstenzeit) Die Telefonkonferenz wird auf Englisch abgehalten. Folgende Einwahlnummern stehen zur Verfügung: +1-800-946-0786 (in den USA) +1-719-457-0786 (von ausserhalb der USA) -- verlangen Sie die Genmab-Konferenzschaltung
Wichtige Präsentationsfolien für die Konferenz stehen bereits vorab unter http://www.genmab.com zur Verfügung.
Informationen zu Genmab A/S
Genmab A/S ist ein Biotech-Unternehmen, das sich mit der Herstellung und Entwicklung menschlicher Antikörper zur Behandlung lebensbedrohlicher und beeinträchtigender Krankheiten befasst. Genmab entwickelt derzeit zahlreiche Mittel zur Behandlung von Krebs, Infektionskrankheiten, chronischem Gelenkrheumatismus und anderen Entzündungskrankheiten und hat sich zum Ziel gesetzt, sein breites Portfolio neuer therapeutischer Produkte kontinuierlich zu erweitern. Genmab unterhält derzeit eine Reihe von Partnerschaften (u.a. mit Roche (Virt-X: ROG.VX - Nachrichten) , Amgen (NASDAQ: AMGN - Nachrichten) und Serono), um Zugang zu krankheitsrelevanten Targets zu erhalten und neue menschliche Antikörper zu entwickeln. Durch eine breitgefächerte Allianz hat Genmab Zugang zu den Technologien von Medarex Inc., u.a. zur UltiMAb(R )-Plattform für die schnelle Entwicklung und Herstellung menschlicher Antikörper für praktisch jedes krankheitsrelevante Target (NYSE: TGT - Nachrichten) . Genmab verfügt über Niederlassungen in Kopenhagen (Dänemark), Utrecht (Niederlande) und Princeton (New Jersey/US). Weitere Informationen zu Genmab erhalten Sie unter http://www.genmab.com.
Diese Pressemitteilung enthält zukunftsgerichtete Aussagen. Zukunftsgerichtete Aussagen können an Begriffen wie "glauben", "erwarten", "vorhersehen", "beabsichtigen" und "planen" oder ähnlichen Ausdrücken erkannt werden. Tatsächliche Ergebnisse bzw. Leistungen können wesentlich von den durch diese Erklärungen ausgedrückten oder implizierten zukünftigen Ergebnissen bzw. Leistungen abweichen. Die Hauptfaktoren, die zu wesentlichen Abweichungen der tatsächlichen Ergebnisse oder Leistungen führen können, umfassen unter anderem Risiken im Zusammenhang mit der Entdeckung und Entwicklung von Medikamenten, Ungewissheiten in Verbindung mit dem Ergebnis und der Durchführung klinischer Studien, darunter unvorhergesehene Sicherheitsrisiken, Ungewissheiten bezüglich der Herstellung eines Mittels, mangelnde Marktakzeptanz unserer Produkte, Schwierigkeiten beim Management des Wachstums sowie des Konkurrenzumfelds in unserem Geschäftsbereich und auf unseren Märkten, unsere eingeschränkte Fähigkeit, qualifiziertes Personal anzuwerben und dauerhaft zu halten, die Nichtdurchsetzbarkeit oder mangelnder Schutz unserer Patente und Urheberrechte, unsere geschäftlichen Beziehungen mit angeschlossenen Unternehmen, technologische Veränderungen und Entwicklungen, die unsere Produkte überholen können, sowie weitere Faktoren. Genmab ist nicht dazu verpflichtet, diese Prognosen nach Veröffentlichung dieser Pressemitteilung zu aktualisieren bzw. in Bezug auf die tatsächlich eingetretenen Ergebnisse zu bestätigen, es sei denn, es gibt eine gesetzliche Verpflichtung hierfür.
UltiMAb(R) ist eine Marke von Medarex (NASDAQ: MEDX - Nachrichten) , Inc.
Genmab(R), HuMax(R), HuMax-CD4(TM) und das Y-förmige Genmab-Logo sind Marken von Genmab A/S.
Website: http://www.genmab.com
Originaltext: Genmab A/S Digitale Pressemappe: http://presseportal.de/story.htx?firmaid=17265 Pressemappe via RSS : feed://presseportal.de/rss/pm_17265.rss2 ISIN: DE0005651327
Pressekontakt: Helle Husted, Director, Anlegerbetreuung, Genmab A/S, +45-33-44-77-30 oder mobil unter +45-25-27-47-13, hth@genmab.com
http://yahoo.reuters.com/...78197_2005-11-16_06-44-04_l1688240_newsml
Roche's MabThera helps arthritis patients
Wed Nov 16, 2005 01:44 AM ET
ZURICH, Nov 16 (Reuters) - Cancer drug MabThera improves the symptoms of patients with rheumatoid arthritis who had failed to benefit from other forms of treatment, Roche Holding AG (ROG.VX: Quote, Profile, Research) said on Wednesday.
In data released at a medical meeting in San Diego, Roche said that its MabThera drug significantly improved all measures of efficacy for rheumatoid arthritis patients for six months following a single course of two infusions of the drug.
The patients tested had previously failed to benefit from so-called anti-TNF therapies which are designed to block an inflammation-causing protein.
The drug is already indicated as a treatment for non-Hodgkin's lymphoma, or lymph cancer. It was developed by Genentech Inc. (DNA.N: Quote, Profile, Research) , majority-owned by Roche, and Biogen Idec (BIIB.O: Quote, Profile, Research) and is marketed in the U.S. as Rituxan.
CORRECTED - UPDATE 1-J&J, Schering-Plough RA drug shows promise in trial
Wed Nov 16, 2005 04:02 PM ET
(In story headlined "Update 1-J&J, Schering-Plough RA drug shows promise in trial," please read in paragraph 9, "An FDA advisory panel backed Bristol-Myers Squibb Co.'s treatment, Orencia, for rheumatoid arthritis ..." instead of "Bristol-Myers Squibb Co. won approval for its rheumatoid arthritis drug Orencia ..." (Correcting to show drug has not yet received FDA approval.)
BOSTON, Nov. 16 (Reuters) - Johnson & Johnson (JNJ.N: Quote, Profile, Research) and Schering-Plough Corp. (SGP.N: Quote, Profile, Research) said on Wednesday that their experimental rheumatoid arthritis drug showed promise in a mid-stage trial.
The companies said that more than 60 percent of patients taking the drug, golimumab, combined with the common treatment methotrexate, saw an improvement in their symptoms of at least 20 percent after 16 weeks.
Results of the phase II trial, presented this week at the annual meeting of the American College of Rheumatology, showed that a quarter of patients receiving the combination treatment achieved remission of their symptoms.
Schering-Plough's shares rose about 1 percent to $19.31 in early trading on the New York Stock Exchange. Johnson & Johnson's shares rose a similar amount to $63.44.
Golimumab is designed to work by blocking an inflammation-causing protein known as tumor necrosis factor. Johnson & Johnson already has a drug on the market -- Remicade -- that blocks the same protein. Amgen Inc.'s (AMGN.O: Quote, Profile, Research) Enbrel and Abbott Laboratories Inc.'s (ABT.N: Quote, Profile, Research) Humira attack the same target.
TNF-inhibitors have been among the most successful of all biotechnology drugs and rheumatoid arthritis, which affects more than 2 million people in the United States, is one of the most hotly-contested disease areas.
Genentech Inc. (DNA.N: Quote, Profile, Research) and Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) recently filed for marketing approval to sell their cancer drug Rituxan as a treatment for rheumatoid arthritis in patients who have failed to respond to TNF blockers.
Roche Holding AG (ROG.VX: Quote, Profile, Research) , which is developing a drug called MRA together with Chugai Pharmaceutical Co Ltd (4519.T: Quote, Profile, Research) sees rheumatoid arthritis as a major area for potential future growth.
An FDA advisory panel backed Bristol-Myers Squibb Co.'s (BMY.N: Quote, Profile, Research) treatment Orencia for rheumatoid arthritis earlier this year to treat patients who fail to respond to one or more other therapies. The FDA is still considering the panel's recommendation that the agency approve the drug.
Orencia is the first of a new class of drugs know as T-cell co-stimulation modulators. The drug works by inhibiting activation of T-cells, components of the immune system involved in inflammation.
Golimumab is being co-developed by Schering-Plough and J&J's Centocor unit.
(Nasdaq ALXN) ließen gestern den Kurs der Aktie um 27% einbrechen.
Details :
Zum Artikel
Alexion sinks on failed drug trial
By MarketWatch
Last Update: 4:52 PM ET Nov. 23, 2005
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BOSTON (MarketWatch) -- Shares of Alexion Pharmaceuticals sank early Wednesday after the company reported disappointing late-stage clinical data for its coronary drug pexelizumab.
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Alexion shares plunged 27% to close at $21.53 on Wednesday.
Cheshire, Conn.-based Alexion (ALXN:
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FinancialsMore ALXNALXN, , ) said a Phase III clinical trial of pexelizumab found that while the drug appeared to reduce the incidence of heart attack or death in some patients who had just undergone coronary bypass surgery, those results were statistically insignificant.
The company plans to present the clinical data at an upcoming scientific meeting. The drug trial, which consisted of about 4,250 heart patients, was cosponsored by the pharmaceuticals division of Procter & Gamble.(PG:
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Alexion also said it will assess what impact the results might have on a second Phase III clinical trial currently testing pexelizumab in patients who had just undergone angioplasty.
"We are clearly disappointed that pexelizumab did not meet its primary endpoint," said Leonard Bell, Alexion's chief executive officer, in a release. "We look forward to completing an analysis of the data and obtaining a more in-depth understanding of these results."
In related news, Alexion also said it was expecting initial results from a Phase III clinical trial for its drug eculizumab for the treatment of a rare blood disorder during the first quarter 2006.
The timing of Alexion's announcement made a research note from Banc of America Securities seem a bit prescient, although the firm's initiation of the stock with a neutral rating may be in jeopardy following the Wednesday's results.
Banc of America asserted that Wall Street didn't fully appreciate the challenges facing Alexion, commercially and clinically. The analysts said they believed the pexelizumab trial for bypass surgery had only about a 50% chance of being successful. They added they believed the on-going Phase III trial for eculizumab had about a 70% chance of success.
Prior to the news, the firm projected pexelizumab would have peak sales of $500 million, if approved. It estimated peak sales of eculizumab would be around $150 million.
--------------------------------------------------
Alexion : HP http://www.alexionpharm.com
Alexion Pharmaceuticals, Inc., together with its subsidiaries, engages in the discovery and development of biologic therapeutic products for the treatment of severe diseases. It develops therapeutic products for the treatment of hematologic and cardiovascular disorders, autoimmune diseases, and cancer; and additional antibody therapeutics for other medical needs. The company primarily develops two lead product candidates, eculizumab and pexelizumab, which address specific diseases that arise when the human immune system produces inflammation in the human body. Eculizumab is in phase III clinical development for treatment of Paroxysmal Nocturnal Hemoglobinuria, a chronic hematologic disease. Pexelizumab is in clinical development for the reduction of the incidence of death, myocardial infarction or heart attack, and other complications associated with coronary artery bypass graft surgery; and for acute myocardial infarction. Alexion Pharmaceuticals has a strategic alliance with Procter and Gamble Pharmaceuticals for the development of pexelizumab. The company was co-founded by Leonard Bell, Stephen P. Squinto, Scott A. Rollins, and Joseph A. Madri in 1992. Alexion Pharmaceuticals is headquartered in Cheshire, Connecticut.
Technologie
Interessante Pipeline:
Pipeline
U.A. auch Kooperation mit Abgenix.
Anmerkung: Die Technologie von AVII ist möglicherweise auch für Entwicklung eines Medikamentes gegen Vogelgrippe geeignet, behauptet jedenfalls das Unternehemen selbst. Auf diesen Zug springen ja derzeit viele auf. ;)
Artikel dazu
Today From Barron's
Virus Killer
By Andrew Bary Published: November 14, 2005
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GROWING GLOBAL CONCERN about a possible pandemic stemming from avian flu have put the spotlight on several drug companies that may have treatments, notably Switzerland's Roche, maker of the highly sought-after anti-viral, Tamiflu.
AVI BioPharma (AVII), a little-known U.S. biotechnology firm, also could be a beneficiary of flu fears because its novel "antisense" drugs may be effective in combating the flu virus, as well as hepatitis C and a range of bio-terror threats, including the dreaded Ebola virus.
Antisense drugs potentially offer an elegant antidote to viral diseases because they're designed to enter cells and eliminate viruses by preventing their replication. The drugs, which act by blocking critical viral genetic sequences, may be more potent than anti-virals such as protease inhibitors, which seek to inhibit a protein needed for viral replication. AVI's specialty is single-strand RNA viruses, which include Ebola, hepatitis C and the flu.
Based in Portland, Ore., AVI has developed a drug, now in early clinical trials, to treat hepatitis C. Its drug to prevent restenosis, or the reclogging of arteries that can occur after angioplasty, is undergoing a clinical trial in Europe. The results from the hepatitis C trial are expected late this year or early in 2006, and the restenosis-trial data are likely next year.
The hepatitis trial, combining the first and second phases of the three trials typically required by the Food and Drug Administration, admittedly is small, involving about 40 sick patients. But, if that trial proves a success, AVI would stand a good chance of forming a potentially lucrative partnership with a major drug maker. Such a pact could help lift the company from obscurity and power its stock, which now languishes around $3 a share.
While AVI has little support on Wall Street, its fans believe it could be a big winner. "AVI has created and patented a core technology that has multiple applications that span everything from infectious disease to restenosis to muscular dystrophy and cancer," says Richard Macary, a managing partner at Corporate Insights, an independent research firm in New York. Macary owns AVI shares.
AVI clearly is a speculative stock. It has no drugs on the market, and minimal revenues other than government grants. As such, it has had to rely on dilutive equity financings, including a $24 million deal earlier this year, to fund itself. AVI has a modest market value of about $140 million, based on 44 million shares outstanding. It has $31 million of cash, enough to last more than a year, given its current annual cash-burn rate of about $22 million.
Unlike most other biotech companies with depressed shares, AVI hasn't had any failures in clinical trials. The company arguably has too much on its plate, and its management has been faulted for not telling its story well to investors and for not moving quickly enough with clinical trials in order to commercialize its products.
E = Estimate
Sources: Company Reports; Legg Mason
What attracts Macary is AVI's technology and the broad range of diseases its drugs presumably could treat, including avian flu. Once AVI's technology is "proven in one area," he says, Wall Street and the drug industry will take notice. That could come with the Phase I/II trial involving AVI's hepatitis C drug. AVI is taking on a difficult disease — a leading cause of liver failure — that may affect 200 million to 300 million people worldwide, including as many as four million in the U.S.
Hepatitis C represents a multibillion-dollar opportunity for any company that can come up with a better treatment than the current standard, a long, toxic and costly regimen involving Interferon and ribavirin that is ineffective in about half of patients. Many drug companies are working on hepatitis C drugs, including Vertex Pharmaceuticals (VRTX
Page 2 of 2)
AVI has developed treatments for a range of bio-terror threats, including the Ebola and Marburg viruses, anthrax and ricin, as well as West Nile virus and dengue fever. A U.S. Senate committee has approved an appropriation of $22 million to the company to pursue these drugs.
If the funds materialize in 2006, it will help AVI move forward with the testing necessary to seek FDA approval. The company has a strong relationship with the U.S. Defense Department and its top lab, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), at Fort Detrick, Md. AVI's Ebola and Marburg treatments have been effective in animals, including primates, but haven't yet been tested in humans.
AVI also has had success in preclinical experiments with a drug to combat the flu. The company now wants to expand its research to animals, and later to humans.
Wall Street analysts generally are cool to AVI, partly because the history of antisense drugs hasn't been a happy one for investors. The FDA failed to approve antisense cancer drugs from Genta (GNTA) and Isis Pharmaceuticals (ISIS) in the past two years, casting a pall over any biotech company pursuing such therapies.
One of AVI's biggest critics on the Street is Legg Mason biotech analyst Edward Nash, who has a Sell rating on the stock. "So we ask ourselves, why would investors invest in AVI with no near-term hope of profitability when they could invest in other biotech companies that have near-term, late-stage clinical, and/or commercialization milestones," Nash wrote in a recent note, titled "AVII: AVI (an) is for the birds."
AVI's situation could change dramatically if its hepatitis C drug trial meets the company's goal of substantially reducing the viral count in diseased patients. Major drug companies are desperate for products, and hepatitis C is considered one of the largest opportunities. Biotech firms with promising drugs, even those not yet in Phase III trials, are reaching lucrative deals with Big Pharma. AVI's chief executive, Denis Burger, says the company is likely to partner with one of several big drug makers if the hepatitis C trial goes well.
AVI was formed in 1980, and its drug platform is supported by more than 100 patents. The company's top executives and directors have significant experience in the drug and biotech industries. Burger, who has been AVI's CEO since the company went public in 1997, acknowledges it's a show-me story. "With the high-profile antisense failures, the Street is leery of the word antisense. Pharmaceutical companies and investors are leery," he says.
Burger says AVI's third-generation Neugene technology differs fundamentally from antisense drugs developed by rivals. AVI drugs use a patented, synthetic chemical backbone to deliver their gene-blocking payload. This structure is designed to prevent the human body's tendency to break them down before they reach target cells.
Antisense drugs also have to overcome other biochemical hurdles, including the ability to cross cellular barriers and then block specific genetic targets. The drugs need to work without causing severe side effects, as safety has been a problem with rivals' drugs. "We've completed 11 human clinical trials involving 250 patients, and we've not had a single drug-related adverse event," Burger says.
AVI can develop a drug quickly once it knows the genetic code of the target virus. With the flu, it strives to target a critical section of the virus that is common to multiple strains. Because the flu virus mutates, a new vaccine must be developed yearly.
Small Firm, Big Targets
AVI Biopharma is developing drugs based on its patented anti-viral technology to combat hepatitis C, which lacks strong existing treatments, and a variety of bioterrorist threats, including Ebola.
Sources: Company Reports
If its technology works, AVI could develop drugs for a host of ailments that have a genetic cause. GlaxoSmithKline (GSK), for instance, is using AVI's technology to develop a treatment for muscular dystrophy. Other applications could include diabetes and multiple sclerosis.
In 2004, a worker at the USAMRIID lab was stuck by a needle while working with Ebola, prompting fears the worker might contract the deadly disease. AVI formulated a drug within days that got special FDA approval, though the worker proved to be unharmed. AVI was then able to test the drug in primates who were given a fatal dose of Ebola, and 75% survived.
The U.S. government is eager for drugs to combat a range of bio-terror threats because few treatments now exist. Ebola, which causes a hemorrhagic fever that is usually fatal, largely has been confined to central Africa. It is transmitted through direct contact with the blood or bodily secretions of those afflicted. The fear is that terrorists could produce an airborne form of Ebola and then seek to infect a city.
If AVI's Ebola and other bio-terror treatments are deemed sufficiently promising, the government could commission the company to produce a significant amount of the drugs for stockpiling. The government already has an $877 million contract with VaxGen (VXGN), a California biotech, to make 75 million doses of an anthrax vaccine. The advantage of AVI's treatment over a vaccine is that it can be used immediately when an outbreak of the disease occurs. Vaccines typically aren't effective for those who already have contracted a disease, and they can take weeks to provide immunity to healthy people. The chief of immunology at USAMRIID, Sina Bavari, said recently that favorable animal tests involving AVI drugs "represent important progress for the potential treatments of these deadly bio-threats," according to an AVI press release.
The Bottom Line
AVI BioPharma's shares trade for $3, but could soar if the company's flu, hepatitis and restenosis drugs move toward FDA approval. That could also lead to a deal with Big Pharma.
One of the knocks against AVI is that it lacks a major drug partner. In 2001, AVI traded up to $12 share after it partnered with Medtronic (MDT), which planned to use AVI's restenosis drug for a new stent. That partnership lapsed in 2004 without producing a drug-coated stent, and its failure has been interpreted as a sign that the AVI drug isn't effective. Drug-coated stents from Boston Scientific (BSX) and Johnson & Johnson (JNJ) now dominate the market. Stents are used as scaffolding to hold open arteries after they've been cleared of blockages. Drug-coated stents have reduced the incidence of restenosis, or the reclogging of arteries, compared with bare-metal stents.
In Europe, AVI is testing its drug in conjunction with bare-metal stents, commonly used on the continent, to see if the combination can achieve similar success at much lower cost. The AVI drug is injected.
A U.S. Phase II trial in 2003 found that AVI's Resten drug, when delivered via catheter, was effective in preventing restenosis. "It's a very good drug," says Dr. Nicholas Kipshidze, a physician and researcher at Lenox Hill Hospital in New York, which conducted the 2003 trial. "We got very good results with inferior delivery. It's less toxic than any other drug we are using. I still believe that Resten will play a role in the stent" market. Kipshidze consults for AVI, but doesn't own stock.
The Street has written off AVI's restenosis drug, just as it has downplayed the potential of its other products. The biotech industry is full of hype, hope and frequent disappointment. Like most biotechs, AVI amounts to a lottery ticket. But, in this case, the payoff just might be huge.
http://www.campath.com/
PR Newswire
Behandlung mit subkutanem (SC) MabCampath(R) (Alemtuzumab) bei Patienten mit fludarabin-refraktärer CLL effektiv und unbedenklich
Montag 12. Dezember 2005, 09:09 Uhr
Atlanta, December 12 /PRNewswire/ --
- Laut Zwischenanalyse ist SC MabCampath so effektiv und gut verträglich
wie IV-Therapie
Gemäss den Zwischenergebnissen der Phase-II-UKCLL02-Studie ist
MabCampath(R) (Alemtuzumab) in subkutaner (SC) Form sowohl effektiv wie auch
gut verträglich im Vergleich zu historischen Patientengruppen, die sich
intravenösen (IV) Behandlungen für fludarabin-refraktäre, chronisch
lymphatische Leukämie (CLL) unterzogen. Die Ergebnisse, die bei der 47.
Jahrestagung der American Society of Hematology (ASH) vorgestellt wurden,
bewiesen, dass fast Anzeige
die Hälfte aller mit SC MabCampath behandelten Patienten
entweder mit partiellem oder vollständigen Ansprechen reagierten, wobei
manche Patienten die MRD-Negativität erreichten (MRD = minimale
Resterkrankung).
"Obwohl MabCampath IV erfolgreiche Ansprechraten zwischen 33 und 50
Prozent erzielt hat, können die Infusionsreaktionen und zweistündigen
Behandlungen, die dreimal pro Woche während eines Zeitraums von 12 Wochen
stattfinden, sowohl in Hinblick auf Nebenwirkungen wie auch den Zeitaufwand
für die Patienten problematisch werden", so Peter Hillmen, M.B, Ch.B,
Facharzt für Hämatologie am Allgemeinkrankenhaus Leeds in Leeds,
Grossbritannien. "Diese Ergebnisse sind für Patienten und Ärzte
gleichermassen sehr ermutigend, da sie zu der Annahme führen, dass SC
MabCampath so effektiv wie die herkömmliche IV-Behandlung sein könnte. Bei
diesen Patienten, deren Behandlung sich als überaus schwierig erwiesen hat,
wird die SC-Behandlung besser vertragen, wobei die einfachere
Verabreichungsmethode ein zusätzlicher Bonus ist."
Ergebnisse der Studie
Von den bis dato 44 ersten untersuchten Patienten haben 36 die Therapie
vollständig abgeschlossen. Die Gesamtansprechrate für MabCampath und die
Fludarabin-Therapie lag bei 44 Prozent (39 Prozent bei ausschliesslich
Campath), wobei drei Patienten in der MabCampath-Monotherapiephase ein
vollständiges Ansprechen (zwei MRD-negativ und eines MRD-positiv) und 11
Patienten ein partielles Ansprechen (einschliesslich einem MRD-negativen
Patienten, der zytopenisch blieb) erreichten. Zwei Nicht-Responder erzielten
partielles Anspechen, als sie mit einer Kombinationstherapie von MabCampath
und oral verabreichtem Fludarabin behandelt wurden, während ein Nicht-
Responder vollständiges Ansprechen erreichte (MRD-positiv). Darüberhinaus
sprachen 20 Patienten mit einer genetischen Disposition zu schlechtem
Ansprechen auf Chemotherapie (p53-Dysfunktion oder Deletion) gut auf die
Behandlung mit MabCampath an.
Die häufigsten Nebenwirkungen, die während der anfänglichen Verabreichung
von MabCampath beobachtet wurden, waren örtlich begrenzte, erythematöse
Hautreaktionen, Fieber und Starre, wobei alle Reaktionen innerhalb von 48
Stunden nach der Behandlung nachliessen. Thrombozytopenie Grad 3+ und
Neutropenie wurden bei je 16 und 25 Patienten beim Monotherapiearm von
MabCampath, bzw. bei einem und zwei Patienten beim kombinierten Therapiearm
beobachtet. Zu den potenziell gravierenden Infektionen, die bei der
MabCampath-Monotherapie auftraten, gehörten die CMV-Reaktivation
(Zytomegalovirus), febrile Neutropenie, invasive Pilzkrankheiten und
Lungenentzündung. Bei den Kombinationstherapie-Patienten trat lediglich
CMV-Reaktivation auf, und alle CMV-Reaktivationen konnten erfolgreich mit
antiviraler Therapie behandelt werden.
Im Vergleich hierzu wurden gewisse ungünstige Prozesse, die mit der
intravenösen Verabreichung einhergingen, insbesondere Schüttelfrost,
Hautausschläge und Übelkeit/Erbrechen, durch die subkutane Verabreichung von
MabCampath drastisch reduziert oder gar eliminiert.
Das mittlere Alter der Patienten lag bei 66 Jahren (zwischen 41 und 79),
wobei 36 Patienten dreimal pro Woche bis zu 24 Wochen (abhängig von der alle
6 Wochen erfolgenden Knochenmark-Beurteilung) eine 30mg-Dosis von SC
MabCampath erhielten. Patienten, die während der subkutanen Verabreichung
kein Ansprechen erreichten, konnten für je drei Tage alle vier Wochen 40mg/m2
orales Fludarabin in Kombination mit SC MabCampath bekommen.
Näheres über chronisch lymphatische Leukämie (CLL)
CLL ist die häufigste Form der Leukämie bei Erwachsenen und befällt
jährlich etwa 120.000 Menschen in Europa und den USA, wobei Patienten im
Alter von 50 Jahren und darüber am häufigsten betroffen sind.
Charakteristisch für CLL ist die Ansammlung funktionell nicht ausgereifter
weisser Blutkörperchen (Lymphozyten) im Knochenmark, dem Blut, Lymphgewebe
und anderen Organen. Es befinden sich zwei Arten von Lymphozyten im Blut, die
B-Zellen und die T-Zellen. Bei etwa 95 Prozent der CLL-Fälle sind krebsartige
B-Zellen im Spiel. Da diese B-Zellen eine längere Lebensdauer als normal
haben, beginnen sie, sich aufzubauen und die normalen, gesunden
Blutkörperchen zu "verdrängen". Die Anhäufung funktionell nicht ausgereifter
Zellen im Knochenmark schliesst die Bildung von gesunden Zellen aus und kann
sich tödlich auswirken. Zu den Symptomen zählen Müdigkeit, Knochenschmerzen,
Nachtschweiss sowie Appetit- und Gewichtsverlust. Wenn das Knochenmark
betroffen ist, kann dies aber auch zu einer Schwächung des Immunsystems
führen, wodurch der Patient einer höheren Infektionsgefahr ausgesetzt ist.
Informationen zu MabCampath(R) (Alemtuzumab)
MabCampath, das in den USA auch unter dem Namen Campath(R) vertrieben
wird, ist der erste und einzige für CLL zugelassene humanisierte monoklonale
Antikörper und das erste Medikament mit bewährter Wirkung bei CLL-Patienten,
die weder auf Alkylantien noch die Behandlung mit Fludara (
Fludarabinposphaten) ansprechen. Keine andere Therapie hat bei dieser
Patientengruppe ähnliche Wirkung gezeigt. Die Wirkungsweise von
MabCampath/Campath und herkömmlichen Behandlungsmethoden ist vollkommen
unterschiedlich, da sich ersteres gezielt gegen das CD52-Antigen der malignen
Lymphozyten richtet. Die hierdurch in Gang gesetzten Prozesse führen zur
Lysis, also dem Tod oder der Auflösung der bösartigen Zellen. Diese Prozesse
führen dann zur Entfernung der malignen Lymphozyten aus dem Knochenmark, dem
Blut und anderen betroffenen Organen, was dann wiederum eine gesteigerte
Lebenserwartung nach sich ziehen kann.
Die bei dieser Indikation auftretenden Nebenwirkungen von MabCampath
können gut unter Kontrolle gebracht werden, wenn das eventuelle Auftreten
opportunistischer Infektionen genau überwacht und entsprechende
prophylaktische Massnahmen dagegen getroffen werden. Diese Nebenwirkungen
sind vorhersehbar, kontrollierbar und reversibel. Darüberhinaus können
Patienten wieder ihre eigenen gesunden Blutkörperchen bilden, da MabCampath
die Stammzellen im Knochenmark nicht angreift.
Ansprechpartner:
Greg Moulds
Leiter der Medienabteilung
Leeds Teaching Hospitals
+44-0113-2066244
Leeds Teaching Hospitals
http://de.biz.yahoo.com/12122005/36/...biets-mabthera-beantragen.html
dpa-afx
Roche will Erweiterung des Anwendungsgebiets von MabThera beantragen
Montag 12. Dezember 2005, 19:12 Uhr
BASEL (dpa-AFX) - Roche (Virt-X: ROG.VX - Nachrichten) wird bei den europäischen Behörden ein Zulassungsgesuch zur Erweiterung des Anwendungsgebiets seines Krebsmittels MabThera einreichen. Wie der Schweizer Pharmakonzern unter Berufung auf neue klinische Daten an diesem Montag mitteilte, bewirkt eine zweijährige Erhaltungstherapie mit dem Präparat eine drastische Verbesserung der Überlebenschancen von Patienten mit indolentem Non-Hodgkin-Lymphom (NHL). Die Erhaltungstherapie soll das Wiederauftreten dieser bösartigen Erkrankung des ANZEIGE
Lymphsystems verhindern. Der Pharmachef von Roche, William Burns, sprach von einem "bislang ungekannten Überlebensvorteil bei dieser als unheilbar geltenden Krebskrankheit". Allein in Westeuropa werde das indolente NHL jährlich bei 20.000 Patienten neu diagnostiziert und rund 40.000 Patienten mit dieser Erkrankung werden behandelt./hi/zb
| 14.12.2005 22:44 |
Amgen will Abgenix für 22,50 Dollar je Aktie in bar plus Schulden kaufen |
Der weltgrößte Biotechnologiekonzern Amgen <AMGN.NAS> <AMG.FSE> (Nachrichten/Aktienkurs) will den Konkurrenten Abgenix <ABGX.NAS> <ANX.ETR> (Nachrichten) für 22,50 US-Dollar je Aktie in bar übernehmen. Der Kaufpreis liege damit bei 2,2 Milliarden Dollar, teilte Amgen am Mittwoch in Thousand Oaks nach Börsenschluss mit. Zudem sollen die Schulden des Biotechnologie-Spezialanbieters übernommen werden. Die Abgenix-Aktie schloss am Mittwoch mit einem Plus von 3,24 Prozent bei 14,65 Dollar. Nachbörslich legte sie 41,23 Prozent auf 20,69 Dollar zu, bevor sie vom Handel ausgesetzt wurde. Amgen-Anteile verbilligten sich unterdessen etwas. Durch die Akquisition, die im ersten Quartal des kommenden Jahres abgeschlossen sein soll, erhalte Amgen den vollen Zugang zum gemeinsam entwickelten Krebsmedikament Panitumumab. Amgen schätzt, dass der jährliche Spitzenumsatzes des Medikaments, dessen Entwicklung den Angaben zufolge weite fortgeschritten ist, bis zu zwei Milliarden Dollar betragen könnte. Das Unternehmen geht davon aus, dass die Übernahme den Gewinn je Aktie vor Sonderposten in den Jahren 2006 und 2007 zwischen fünf und zehn Cent belasten wird. Danach werde die Akquisition im Falle eines kommerziellen Erfolgs von Panitumumab den Gewinn je Aktie vor Sonderposten positiv beeinflussen. Zur Höhe der Schulden, die Amgen übernimmt, machten die Unternehmen keine Angaben. Den zuletzt veröffentlichten Zahlen zufolge hatte Abgenix per Ende September neben einer ausstehenden Wandelanleihe von knapp 450 Millionen Dollar rund 85 Millionen Dollar ausstehende Schulden./zb/hi ISIN US0311621009 US00339B1070 AXC0182 2005-12-14/22:39  |
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