Novelos Therapeutics
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Eröffnet am: | 21.01.07 12:30 | von: Gretel | Anzahl Beiträge: | 52 |
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Gruß Gretel
NOV-002, Cancer
NOV-002, the lead compound acts as a chemoprotectant and an immunomodulator, in combination with chemotherapy. In the U.S., Novelos received a "green light" from the FDA for Phase 3 development of NOV-002 for treatment of lung cancer, under a Special Protocol Assessment (SPA) and Fast Track. NOV-002 is approved and marketed in the Russian Fereration by Pharma BAM under the trade name Glutoxim®. It has been administered to over 5,000 patients, demonstrating clinical efficacy and excellent safety data.
In the U.S.
The Russian preclinical and clinical data have been sufficiently compelling that the United States Food and Drug Administration (FDA) has accepted them as part of the Investigational New Drug Application (IND) that Novelos has filed for NOV-002.
The U.S.-based Phase 1/2 clinical trial of NOV-002 for non-small cell lung cancer (NSCLC) has been completed, with positive results. Forty-four chemotherapy-naive Stage IIIb/IV NSCLC patients (late-stage lung cancer patients who have not received prior chemotherapy) were randomized to one of three groups for six months of treatment:
Group A: NOV-002, administered intravenously (IV) and intramuscularly, in combination with cytotoxic chemotherapy.
Group B: NOV-002, administered IV and subcutaneously (SC), in combination with cytotoxic chemotherapy.
Group C: Cytotoxic chemotherapy alone was administered to this control group.
Based on the trial protocol, the intent-to-treat analysis of the best overall objective tumor response (i.e. complete or partial tumor shrinkage) showed that eleven out of sixteen (69%) NOV-002 treated patients in Group B demonstrated greater than 50% tumor shrinkage versus only five out of fifteen (33%) in the control group (C). This difference was statistically significant (p=0.044 in a stratified analysis). Six out of thirteen (46%) patients in Group A demonstrated an objective response.
Further, NOV-002 treated patients better tolerated cytotoxic chemotherapy as evidenced by their ability to receive more cycles of chemotherapy compared to the control group (C). 100% of patients in Group B and 85% in Group A were able to complete four cycles of chemotherapy, while only 50% of control group patients (C) were able to do so. These differences were statistically significant (p=0.004). In addition, NOV-002 was well tolerated in this patient population, adding to NOV-002’s already extensive safety database.
During the End-of-Phase 2 meeting, the FDA agreed that advancing NOV-002 into a pivotal Phase 3 trial in advanced NSCLC, in combination with first-line chemotherapy, is warranted. In May 2006, Novelos finalized a SPA with the FDA for a single pivotal Phase 3 trial, and obtained Fast Track designation in August 2006.
Novelos\' randomized, open-label, international Phase 3 trial will evaluate NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in 840 patients with Stage IIIb/IV NSCLC. The trial, with a primary efficacy endpoint of improvement in overall survival, will be conducted across approximately 10 countries and 100 clinical sites. Novelos expects commencing the trial in November 2006, and anticipates reaching full enrollment in the first quarter of 2008.
NOV-002 is also being developed to treat chemotherapy-resistant ovarian cancer. A U.S. Phase 2 trial is ongoing at Mass General Hospital and Dana Farber Cancer Institute.
NOV-002 is also being developed to treat early-stage breast cancer. These patients are often treated with chemotherapy to minimize or avoid surgical intervention. A planned U.S. Phase 2 trial will evaluate the ability of NOV-002 to enhance the effectiveness of such chemotherapy while diminishing dose-limiting side-effects.
NOV-002 is in addition being developed to treat acute radiation injury.
Click below for:
Poster Presentation of NOV-002 Phase 1/2 Lung Cancer Trial
Poster Presentation of NOV-002 Mechanism of Action
In Russia
Numerous clinical studies have been concluded in the Russian Federation over the last decade, and NOV-002 was approved as an adjunct to chemotherapy in the Russian Federation in 1998. The Russian approval was obtained by demonstrating clinical efficacy and excellent safety in 340 patients with various types of cancers, including: non-small cell lung, colorectal, breast, ovarian, pancreatic, etc.
Overall, the studies revealed that NOV-002 could be safely and effectively added to various chemotherapy regimens. The treated patients had a better quality of life and more rapid restoration of hematological and immunological indices. They tolerated the combination therapy better than standard chemotherapy alone, as evidenced by receiving greater number of chemotherapy cycles. Further, in a controlled Russian lung cancer trial, when used in combination with chemotherapy, NOV-002 increased the one year survival rate of patients from 17% to 63%, a result that represents an 80% improvement over the 35% survival rate seen with the current standard of care in the U.S..
NOV-002 also sensitized previously platinum-resistant ovarian cancer patients to chemotherapy in a Russian-based trial. In combination with NOV-002, 80% of the treated women responded favorably to the same chemotherapy that they previously failed.
NOV-205, Hepatitis
NOV-205 is being developed to treat chronic hepatitis C in the U.S. NOV-205 acts as a hepatoprotective agent with immunomodulating and antiinflammatory properties. The FDA accepted Novelos\' Investigational New Drug Application (IND) for NOV-205. The initial U.S.-based Phase 1b trial will evaluate NOV-205 as monotherapy for chronic hepatitis C genotype 1 patients who have failed pegylated interferon plus ribavirin therapy. The trial commenced in September 2006.
NOV-205 is approved for use in the Russian Federation under the trade name Molixan®. Commercialization of NOV-205 is commencing in Russia. Clinical studies in 178 Russian hepatitis patients have demonstrated that NOV-205 is effective and safe. The Russian clinical studies in hepatitis B and C patients showed that after relatively short treatment periods (1 to 2 months) with NOV-205, viral load was undetectable in a high proportion of patients and serum biochemical markers of liver damage were significantly decreased. Overall, more than 700 Russian hepatitis patients have been treated successfully with NOV-205. Preclinical studies also support NOV-205\'s anti-viral and hepatoprotective effects.
Tschau Gretel
Novelos Therapeutics Announces $15 Million Private Placement
NEWTON, Mass.--(BUSINESS WIRE)--
Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has entered into a definitive agreement with institutional investors to raise $15 million in gross proceeds through the sale of shares of a new series of its convertible preferred stock and warrants to purchase its common stock. Novelos has agreed to sell 1,500 shares of Series B convertible preferred stock, having a stated value equal to $10,000 per share, a cumulative annual dividend of 9% of stated value and a conversion price of $1.00 per share of common stock. The investors will also receive warrants, callable in certain circumstances, expiring in five years to purchase an aggregate of 7,500,000 shares of common stock at an exercise price of $1.25 per share. The transaction is expected to close in seven to ten days, subject to the satisfaction of certain closing conditions.
The investors include Xmark Opportunity Funds, OrbiMed Advisors, and other selected institutional investors. Rodman & Renshaw, LLC is serving as the placement agent, and Emerging Growth Equities, Ltd is serving as the sub-placement agent for the transaction, and will receive a placement agent fee consisting of cash and warrants to purchase Novelos common stock at the closing of the transaction. The preferred stock and warrants will be issued in a private placement transaction under Regulation D of the Securities of Act of 1933. Novelos is required to file a registration statement covering the common stock underlying the preferred stock purchased by the investors and the common stock underlying the warrants within 30 days of the closing and to use its best efforts to obtain effectiveness within 90 days of the closing.
"We are very pleased to have these excellent institutional investors participate in the financing, which will provide funds for Novelos' current development program through mid-2008," said Harry Palmin, President and CEO of Novelos. "Furthermore, if all the warrants are exercised for cash, Novelos would receive about $10 million of additional proceeds. Fundamentally, we continue to anticipate that our pivotal Phase 3 lung cancer trial will be fully enrolled by the end of the first quarter of 2008. Meanwhile, we expect earlier stage clinical trial results later this year."
Tschau Gretel
Novelos Therapeutics: Blockbusterpotenzial durch neuen Krebswirkstoff
00:17 16.04.07
Mehr und mehr wird das US-Biotechnologieunternehmen Novelos Therapeutics auch in Deutschland bekannt. Nach einem Tief zur Jahreswende von ca. 0,60 US-$ notieren die Aktien jetzt ungefähr doppelt so hoch. Novelos hat interessante Wirkstoffansätze gegen Krebs in der Hinterhand: Grund genug also, sich das Unternehmen auf die Watchlist zu setzen.
Programmierter Zelltod
Die Bostoner verfolgen einen ganz eigenen Ansatz, Krebszellen zu bekämpfen. Dabei wird an den Selbstzerstörungsmechanismus von Zellen appelliert, die von Krebs befallen sind, den so genannten „programmierten Zelltod“. Hintergrund ist, dass sich veränderte Zellen durch einen hohen Anteil an Proteinsträngen auszeichnen und auch nicht die ansonsten vorhandenen typischen Faltungen zeigen. Schlüsselwirkstoff ist Novelos’ NOV-002.
Zulassung in Russland
In Russland gab es dafür bereits die Freigabe von den dortigen Behörden. Angeblich werden damit bereits tausende Patienten behandelt und zeigten überwiegend signifikante Besserung beim nicht-kleinzelligen Lungenkrebs. Eine Placebo-Gruppe hatte auf Sicht von 12 Monaten eine Überlebensrate von nur 17 %, dagegen kam die mit NOV-002 behandelte Gruppe auf 63 % (Phase II-Studie mit 340 Patienten). Diese Ergebnisse wurden durch eine Phase I/II-Untersuchung in den USA vor einiger Zeit bestätigt. Dabei ist der wirksame Bestandteil, Gluthathione, schon seit fünf Jahrzehnten Gegenstand klinischer Forschung mitsamt 10.000 wissenschaftlicher Veröffentlichungen dazu, doch erst Novelos scheint die richtige Variation gefunden zu haben.
Dreifach-Wirkung
Doch es kommt noch besser. NOV-002 weist gegenüber anderen, „normalen“ Krebsmedikamenten gleich drei Vorteile auf. Zum einen verhindert es, dass Krebszellen giftige Stoffe freisetzen können. Zweitens scheint NOV-002 dem Anschein nach auch die Toleranz bei Chemotherapien heraufzusetzen, z.B. indem mehr rote Blutkörperchen gebildet werden. Und schließlich werden drittens auch vermehrt weiße Blutkörperchen gebildet, die das Immunsystem stärken, was für behandelte Patienten oftmals ein Flaschenhals ist. Diese Dreifachwirkung sucht innerhalb der Universums für Krebsmedikamente ihresgleichen.
Blockbuster-Potenzial für NOV-002
Derzeit läuft eine placebokontrollierte randomisierte Phase III-Studie, deren Registrierung Anfang nächsten Jahres erwartet wird, Ergebnisse im weiteren Jahresverlauf. Zusätzlich wurden quasi Machbarkeitskonzepte für chemotherapieresistenten Eierstock- und Brustkrebs entworfen, um die Indikationen auszuweiten. Dies alles zusammen macht NOV-002 zu einem potenziellen Blockbuster-Medikament mit jährlichen Umsätzen von über 1 Mrd. US-$ bis zum Jahr 2018.
Derzeit ein Schnäppchen
Weil das eben noch ein wenig Zukunftsmusik ist, notiert Novelos mit einer Marktkapitalisierung von ca. 50 Mio. US-$. Analysten des Researchhauses Rodman & Renshaw preisen eine 40%-ige Erfolgswahrscheinlichkeit von NOV-002 ein, was jedoch angesichts der bereits in Russland erfolgten Zulassung und der durchschlagenden Ergebnisse recht konservativ erscheint, zumal die meisten Wirkstoffe nicht in Phase III, sondern in Phase II scheitern. Der risikoadjustierte Net Present Value liegt diesen konservativen Annahmen zufolge bei rund 3 US-$ die Aktie, also beim mehr als Doppelten des aktuellen Kurses.
Mit Wirkstoffen gegen Hepatitis B und C (NOV-005) ist Novelos weniger weit fortgeschritten. Versucht wird aber der selbe Behandlungsansatz wie beim Krebswirkstoff, basierend auf der Dreifachwirkung, was im Erfolgsfall wiederum den allermeisten bisherigen Wirkstoffen überlegen wäre.
Fazit
Novelos ist ein typisches Biotechnologie-Unternehmen, allerdings ein besonders viel versprechendes: Lead-Produkt NOV-002 verfügt über Blockbusterpotenzial. Geht man von der von Rodman & Renshaw veranschlagten Erfolgswahrscheinlichkeit von 40 % aus, so haben Sie eine 40 %ige Wahrscheinlichkeit auf mindestens eine Kursverdopplung.
Wir denken, dass diese Chance das Risiko lohnt: Erstens halten wir die 40 % für konservativ, zweitens zeigen die bisherigen Ergebnisse, dass hinter NOV-002 mehr stecken könnte als bislang im Markt bekannt. Der Kurs liegt aktuell bei ziemlich genau 1,00 Euro. Versuchen Sie, ein paar Stücke aufzugabeln, sofern Sie eine gewisse Biotechnologie-Affinität mitbringen.
Für die Inhalte ist die Redaktion des Performaxx-Anlegerbriefs verantwortlich. Der Performaxx-Anlegerbrief zählt mit einer Musterdepotperformance von über 710 % (seit 1.1.2001) zu Deutschlands erfolgreichsten Börsenbriefen. Weitere Informationen finden Sie unter www.performaxx-anlegerbrief.de.
Tschau Gretel
NVLT: To Present Data re NOV-002 Phase III Trial for Lung Cancer
By Fain Hughes, fhughes@knobias.com
Novelos Therapeutics, Inc. (NVLT) announced that the company, in collaboration with Dr. Kenneth Tew and Dr. Danyelle Townsend of the Medical University of South Carolina (MUSC), is making two poster presentations at the ongoing American Association for Cancer Research annual meeting. These presentations will highlight in vivo and in vitro findings with NOV-002, which is currently in a pivotal Phase 3 trial for non-small cell lung cancer and Phase 2 trials for other oncology indications.
http://www.novelos.com/docs/...hrotox%20and%20s-glutathionylation.pdf
Da wird also im Kurs nicht viel passieren.
Tschau Gretel
was mich schon seit einiger Zeit wundert, dass es Biotech-Aktien gibt, die eine bedeutend schlechter Pipeline haben und die mit Traumkursen an der Börse gehandelt werden.
Beispiel: GPC Biotech die Aktie wurde monatelang mit 27€ gehandelt und hatte gerade mal ein einziges Preparat im Visier. Das ging dann vor ca. 4 Wochen den Bach herunter und die Aktie ist immernoch 1,90€ am Kurssturztag und jetzt 3,19€ wert! Die Aktie hat fehlgeschlagene Ergebnisse die Testgruppe mit dem Preparat und die ohne hatten genau die gleichen Ergebnisse!! Wie tot soll eine Aktie noch sein???
Damit im Hinterkopf muss man mal vergleichen: Novelos hatte noch nie über 3€ gelegen und hat zum einen NOV002, dass nicht nur eine Anwendbarkeit hat sondern momentan 4 verschieden und dann auch noch die Hepatitis-Geschichte. Die Test für die NOV002 haben gute Ergebnisse gebracht. Die Gruppen haben mit Medikament 3 x so hohe Überlebenschancen wie die ohne. Sicher die 3. Phase läuft erst im März nächstes Jahr an, aber die Perspektive ist eine vollkommen Andere und im übrigen fragt Euch mal warum deutsche Biotech-Firmen in USA so schwer die Zulassung bekommen?? Für NOV 002 haben die sogar schon den Fasttrack, den Kandidaten wie GPC und Paion nie bekommen hätten.
Einstiegskurse bis 0,50 Cent sind für mich persönlich alles Gewinner. Habe selber gemicht in kleinen Päckchen gekauft. Klar ist auch auf kurze Sicht ist hier kein großes Geld zu verdienen, aber mit Blick auf 1 Jahr Liegezeit und langfristige Erwartung ...
Das sind meine persönlichen Gedanken und Infos von den amerikanischen Veröffentlichungen und ich hoffe eine interessante Diskussion angestoßen zu haben. Vielleicht auch eine Antwort für Gretel!
Gruß, Manfred
Lee’s Pharmaceutical ("Lee’s Pharm") will be responsible for the cost of all clinical development, regulatory submissions and commercialization of NOV-002 and NOV-205 in China. In addition to upfront and milestone payments, Novelos will receive 20-25% royalties from Lee’s Pharm on net sales of NOV-002 and 12-15% royalties on net sales of NOV-205.
“I am very pleased to be collaborating with Lee’s Pharm, a vibrant public company that has a proven track record of developmental and commercialization expertise in China,” said Harry Palmin, President and CEO of Novelos. “The significant royalties allow Novelos greater participation in China’s rapidly growing marketplace, particularly in critical disease areas of cancer and hepatitis. This deal also marks the commencement of Novelos’ ex-US partnering initiative.”
“We are excited about the opportunity to work with Novelos on its two exciting compounds NOV-002 and NOV-205,” said Dr. Benjamin Li, CEO of Lee’s Pharm. “With over 1.7 million people being diagnosed with cancer each year and over 120 million people being infected with hepatitis B virus, both cancer and hepatitis B are major health problems facing China today. Better treatment options are badly needed in those areas and the market potential for innovative and effective treatment will be enormous.”
About Lee’s Pharmaceutical Holdings Ltd
Lee’s Pharmaceutical Holdings Limited is a Hong Kong listed (Stock code: 8221) biopharmaceutical company with over 13 years operation in China’s pharmaceutical industry. It is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, marketing and sales in China with global perspective and it currently markets five products in China. The Group focuses on several different areas such as cardiovascular and infectious diseases, dermatology, oncology and gynecology with more than 10 products under different development stages stemming from both internal R&D as well as from the recent acquisition of licensing and distribution rights from various US and European companies. For additional information about Lee’s Pharm, please visit www.leespharm.com
About Sigma Tau
Sigma-Tau Group is a leading research-based Italian pharmaceutical group founded in 1957. Sigma-Tau Group had annual revenues equivalent to approximately US$1 billion in 2006 with 2,500 employees worldwide. Therapeutic areas in which Sigma-Tau Group’s research and development are focused include cardiovascular disease, metabolism, oncology, immunology, central and peripheral nervous system with 47 projects, 30 clinical indications studied with 17 proprietary molecules, most of which are new and original. Sigma-Tau Group has operating subsidiaries throughout Europe and the United States and maintains a presence in all of the world’s major pharmaceutical markets, including in the rapidly growing Chinese market through its significant shareholding in Lee’s Pharm. For additional information about Sigma Tau, please visit www.sigma-tau.com – www.sigma-tau.it
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, the lead compound currently in Phase 3 development for lung cancer under a SPA and Fast Track, acts together with chemotherapy as a chemoprotectant and an immunomodulator. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is in addition being developed for acute radiation injury. NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were originally developed. For additional information about Novelos please visit www.novelos.com
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.
Novelos Therapeutics, Inc.
COMPANY
Harry S. Palmin, 617-244-1616 x11
President and CEO
hpalmin@novelos.com
or
INVESTOR RELATIONS
Stephen Lichaw, 201-240-3200
slichaw@novelos.com