Dynavax 17.12.2008 zu 0.6€ gekauft
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http://www.businesswire.com/portal/site/home/...05272&newsLang=en
April 27, 2009 06:45 AM Eastern Daylight Time
Dynavax Presents Additional Phase 3 Data for HEPLISAV™ Hepatitis B Vaccine at EASL Medical Conference
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX)
............
BERKELEY, Calif., Apr 28, 2009 (BUSINESS WIRE) -- Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the first quarter ended March 31, 2009.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=380318
lala...
Dynavax Presents Data From Novel Universal Flu Vaccine Candidate
Proprietary Approach for Protection Against Influenza
http://www.businesswire.com/portal/site/home/...05250&newsLang=en
lala...
In reply to: _bbb_ who wrote msg# 212538 Post # of 212539
10x DVAX truth moment is due in a month...
http://files.shareholder.com/downloads/DVAX/...09%20-%20FINAL_4pm.pdf
This study successfully demonstrated that a short, 2 dose
regimen of HEPLISAV is superior to the current 3 dose
regimen of Engerix-B
• HEPLISAV demonstrated earlier protection and greater rate
of seroprotection at all time points in the study
• It is expected that the shorter schedule in association with
early protection will result in increased compliance and
better protection against Hepatitis B infection
• In the subjects evaluated to date, HEPLISAV has a safety
profile similar to Engerix-B
ANCA-Associated Vasculitis
• Two cases of ANCA-associated vasculitis occurred during
subject participation in this clinical trial, one in each treatment
group (1/1,820 vs. 1/608, p=0.4382)
• One subject developed p-ANCA vasculitis (MPA) in the
Engerix-B treatment group (0/1,820 vs. 1/608, p=0.2504)
• One subject developed c-ANCA vasculitis (WG) in the
HEPLISAV treatment group (1/1,820 vs. 0/608, p=1.0000)
• There is no apparent difference in the occurrence of ANCAassociated
vasculitis, MPA or WG, between treatment groups
phast study demonstrates that heplisav (dvax hepatitis b drug) is better than current lead drug, engerix b of glaxo.
if fda will lift clinical hold on heplisav, dvax will follow vnda trend...first for the approval of drug, then the sale of commercial rights to a major pharma...will glaxo buy dvax or heplisav right if it will confirmed that heplisav is better than engerix b?
fda will make its response at any time in the second quarter, june 30 is day after day closer...
dvax will end 2009 with at least 50 millions cash, or 1,26, it's trading below cash. If drug approved, 5/10 $ will be the trading range of dvax for
In reply to: _bbb_ who wrote msg# 418 Post # of 423
DVAX READ PHAST CONCLUSIONS...FDA WILL SOON REMOVE CLINICAL HOLD AND IF DRUG APPROVED, I SMELL BUYOUT BY GLAXO OR OTHER COMPETITOR, FDA APPROVED VNDA ILOPERIDONE (NO HOPE AND NO ADDITIONAL DATA) WHY DON'T APPROVE HEPLISAV THAT COULD BE BETTER OF ENGERIX B?
LINK HERE
http://files.shareholder.com/downloads/DVAX/...09%20-%20FINAL_4pm.pdf
May 13, 2009 06:45 AM Eastern Daylight Time
Dynavax Awarded Grant to Support Development of TLR Inhibitors in Skin Diseases
http://ih.advfn.com/...50930&article=37769493&symbol=N%5EDVAX
http://www.nytimes.com/2009/05/19/science/...wanted=2&ref=science
lala...
As flu fears loom, will niche vaccine makers cash in?
H1N1 scare gives stocks a sharp boost, but companies face challenges
http://www.marketwatch.com/story/...boost-from-flu-scare?siteid=yhoof
Dynavax Presents Additional Phase 3 Data for HEPLISAVTM Hepatitis B Vaccine at DDW Medical Conference
HEPLISAV Demonstrates Rapid, Increased Protection for Adults
Digestive Disease Week
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX) today presented additional Phase 3 clinical data for HEPLISAVTM hepatitis B vaccine in a poster session at the Digestive Disease Week (DDW) medical conference in Chicago. In addition to meeting its primary endpoint in this Phase 3 trial as previously reported, HEPLISAV provided more rapid and increased seroprotection against hepatitis B viral infection and with fewer doses than the licensed vaccine. The data show the differences to be particularly significant in the subset of subjects over 40 years of age who are usually less likely to respond to immunization.
“Vaccination is critical for the prevention of hepatitis B viral infection and its spread, but the lengthy dosing regimen of current vaccines leaves many unprotected,” commented Scott A. Halperin, M.D., Director Clinical Trials Research Center, Dalhousie University, IWK Heath Centre of Halifax, Nova Scotia and Lead Investigator in the Phase 3 trial. “The Phase 3 data demonstrate HEPLISAV’s superior immunogenicity and similar safety profile versus the licensed vaccine, particularly for adults over 40 who are more difficult to protect against this preventable viral infection.”
This Phase 3 trial referred to as PHAST (Phase 3 HeplisAv Short-regimen Trial) evaluated more than 2,400 adults. The seroprotection rate at the primary endpoint was 95% in subjects receiving 2 doses of HEPLISAV at 0 and 1 month, compared to 81% in subjects receiving 3 doses of licensed vaccine Engerix-B® at 0, 1, and 6 months.
In a subanalysis of subjects over 40 years of age, at each time point during the trial there was a statistically significant (p < 0.0001) difference in the seroprotection rate for subjects receiving HEPLISAV or Engerix-B.
Ages 40-55
Dosing Regimen
Seroprotection Rate (1)
Treatment Group
at Month
1 2 3 6 7
HEPLISAV 2 doses (0, 1 month) 18% 84% 92%(2) 97% 97%
Engerix-B 3 doses (0, 1, 6 months) 3% 21% 17% 27% 75%(2)
(1) Seroprotection rate – percentage of subjects with anti-HBsAg antibodies ≥ 10 mlU/mL
(2) Primary endpoint
A copy of the poster is available at http://investors.dynavax.com/newsevents.cfm. Dynavax’s abstract #587659 is titled “A Phase 3 Safety and Efficacy Study to Compare Immune Responses following Either Two Doses of Hepatitis B Surface Antigen Combined with Immunostimulatory Phosphorothioate Oligonucleotide (HBsAg-ISS) or Three Doses of Conventional Hepatitis B Vaccine.”
As previously reported, safety results from this trial demonstrated the safety profile of HEPLISAV and Engerix-B appeared similar. Subjects were randomized 3 to 1 to receive HEPLISAV or Engerix-B and one case of vasculitis was reported in each of the treatment groups. Following the report of the severe adverse event of Wegener's granulomatosis, an uncommon form of vasculitis, HEPLISAV was placed and remains on clinical hold by the U.S. Food and Drug Administration (FDA). Dynavax is in active discussions with regulatory agencies to resolve the FDA’s clinical hold on HEPLISAV and identify an appropriate path for its further development and approval in the United States, Europe, and the rest of the world.
About HEPLISAV
HEPLISAV is a Phase 3 hepatitis B vaccine aimed at unmet medical needs in the vaccination of adults and end-stage renal disease patients by providing rapid and increased protection with fewer doses. HEPLISAV combines a proprietary immunostimulatory sequence (ISS), which targets Toll-like Receptor 9, with hepatitis B surface antigen (HBsAg).
About Hepatitis B
Hepatitis B is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. There is no cure for hepatitis B and disease prevention through effective vaccines is critical to reducing the spread of the disease. Current hepatitis B vaccines for adults usually require 3 doses given over 6 months to provide seroprotection of approximately 30%, 75%, and 90% after the first, second, and third doses respectively. The effectiveness of current vaccines is further compromised because only 30% of people receive all 3 doses.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
About DDW
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 30 – June 4, 2009, at the McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
Forward Looking Statements
This press release contains “forward-looking statements,” that are subject to a number of risks and uncertainties, including statements related to the nature of communications with regulatory agencies regarding HEPLISAV. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the FDA will remove the clinical hold for HEPLISAV, whether HEPLISAV can be further developed, financed or commercialized, or even if further development is permitted, that successful clinical development and regulatory approval can occur in a timely manner or without significant additional studies and difficulties or delays in development, the Company's ability to obtain additional financing to support its operations; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Engerix-B® is a registered trademark of GlaxoSmithKline
Contacts
Dynavax Technologies Corporation
Amy Figueroa, 510-665-7211
Investor Relations and Corporate Communications
afigueroa@dynavax.com
Permalink: http://www.businesswire.com/news/home/20090603005196
MFG
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BERKELEY, Kalifornien, October 20 /PRNewswire/ --
Präklinische Studien zeigen: mit konservierten Virusproteinen gepaarte
TLR9 Agonisten bieten 30-fach verdünnte Dosierung von
Standardvackzinkomponenten
Dynavax Technologies Corporation (Nasdaq: DVAX) gab heute bekannt, dass
das Unternehmen auf der am morgigen Freitag, dem 20. Oktober in Wien
(Österreich) stattfindenden "Second International Conference on Influenza
Vaccines for the World" seine jüngsten präklinischen Daten vorstellen wird.
Diese zeigen, dass das Influenza (Grippe-) Vakzin des Unternehmens die
Immunisationskraft von Standard-Grippevakzinen verbessern kann. Dynavax liess
verlauten, dass die Daten aus dem Maus- bzw. Primatenmodell zeigten, dass die
gemeinsame Verabreichung des Grippevakzins von Dynavax mit einem
Standard-Vakzin die Immunreaktion des Standardvakzins stärkt, eine
Verringerung der Dosierung des Standardvakzins erlaubt und stammunabhängige
Extra Protection Layer bietet. Das Vakzin von Dynavax basiert auf der
unternehmenseigenen TLR9 Agonisten-basierten ISS-Technologie (ISS,
Immunostimulatory Sequence). Die Finanzierung der Arbeit wurde zu einem Teil
durch einen Zuschuss von 3,0 Mio. USD des National Institute of Allergy and
Infectious Disease (NIAID), eine Abteilung der National Institutes of Health,
für die Erforschung und Entwicklung eines pandemischen Influenza Vakzins
ermöglicht.
Auswirkungen für die Entwicklung von künftigen Grippevakzinen
"Unsere Ergebnisse bei der Grippe machen uns zuversichtlich, dass wir
bald in der Lage sein werden, den Schritt hin zu einem kommerziellen Produkt
zu machen. In den anderen Infektionskrankheits-Vakzinprogrammen von Dynavax,
sagten die präklinischen Daten genau die später in den klinischen
Humanstudien ermittelten Ergebnisse voraus", meint Gary Van Nest, Ph.D., Vice
President of Preclinical Research bei Dynavax.
Van Nest erläutert: "Standard-Grippevakzine bieten Schutz gegen eine
Virusinfektion, indem sie neutralisierende Antikörper gegen die
Virus-Oberflächenproteine (Hämagglutinin bzw. HA und Neuraminidase bzw. NA)
erzeugen. Sobald es zu einer unzulänglichen Antikörperproduktion oder einer
Nichtübereinstimmung zwischen dem Vakzin und dem zirkulieren Virus kommt,
kann die Wirksamkeit des Standardvakzins drastisch abnehmen. Das Dynavax
Universal Flu Vakzin verbessert nicht nur die Blockierung bzw.
Neutralisierung des Virus sowie die Wirkungen des koadministrierten
Standard-Grippevakzins. Es tötet auch auf eine vom Virenstamm unabhängige
Weise alle vom Virus infizierten Zellen und verhindert so dessen Ausbreitung,
was zu Lungenentzündung und oftmals anderen tödlichen Sekundärkrankheiten
führen kann."
"Unsere aufregenden Ergebnisse," fügt Van Nest hinzu, "werden produziert,
indem unsere TLR9 Agonisten (ISS) an die hochgradig konservierten
Virusproteine, Nucleoprotein (NP) und extrazelluläre Domain-of-Matrix Protein
2 (M2e), gekoppelt werden. NP-ISS induziert starke T-Helfer 1 (Th1) und
zytotoxische T-Zellen-Reaktionen (CTL), die die vom Virus infizierten Zellen
töten. M2e-ISS induziert starke zytotoxische Antikörperreaktionen, was
ebenfalls infizierte Zellen tötet und somit die Krankheitsschwere beschränkt.
Es ist tatsächlich so, dass - auch wenn ein Standard-Grippevakzin nicht mit
dem jahreszeitlichen Virus übereinstimmt - unser universelles Grippevakzin
potenziellen Schutz gegen Viruserkrankungen bietet, wenn es gleichzeitig mit
einem beliebigen Standardgrippevakzin angewendet wird."
Daten aus Wien
In der Präsentation in Wien mit dem Titel "Induction of Broadly
Protective Cellular Immune Responses Using an ISS Conjugate Vaccine"
beschreibt Debbie Higgins, Senior Manager, Preclinical Programs bei Dynavax,
die Arbeit von Dynavax und von deren Mitarbeitern am Influenza Research
Center am Baylor College of Medicine.
Die Studien lassen vermuten, dass durch Anfügen von ISS-gekoppelten
konservierten Antigenen an Standardvakzine es möglich ist, die Wirksamkeit
von beliebigen trivalenten Standard-Influenza-Vakzinen zu erhöhen bzw. die
Dosierung von Standardvakzinen bei gleichzeitiger Wirksamkeitssteigerung zu
verringern. Die Daten zeigen die Verbesserung von funktionalen
Antikörperreaktionen gegen die Vakzinstämme. Im Einzelnen:
Bei Mäusen ergab NP-ISS gemeinsam mit Standardvakzin (Fluzone(R),
sanofi-aventis) verabreicht, signifikant gestiegene
Antikörperreaktionen bei 30- fach weniger Fluzone.
Primate (Paviane), die mit NP-ISS und Standardvakzin immunisiert
wurden, entwickelten bessere Fluzone-specifische Antiköperreaktionen,
gemessen durch Analyse der Hämagglutination Inhibition und der
Viralneutralisation.
Die ISS-Koppelung an ein kurzes M2e-Peptid (M2e-ISS) generierte eine
starke M2e-spezifische Antikörperreaktion.
Im August 2006 präsentierte Dynavax auf der "Novel Vaccines: Bridging
Research, Development and Production" Konferenz in Cambridge, Massachusetts
(USA), Daten, die sowohl die Fähigkeit des Grippevakzins des Unternehmens zur
Verleihung von ´cross-protective´ Zellimmunität gegen grösstenteils
divergente Grippestämme bei Mäusen als auch dessen Potenzial als universelles
Grippevakzin, belegten. Die Daten liessen vermuten, dass das Vakzin das
Potenzial besitzt, jährliche Impfungen überflüssig zu machen und dass die
Bevorratung des Vakzins für den Pandemiefall möglich sein könnte. Es konnte
gezeigt werden, dass das Dynavax Grippevakzin spezifischen Schutz gegen
"Antigendrift" und "Antigenshift" bietet. Mit der NP-ISS-Paarung immunisierte
Mäuse, die anschliessend Drift- und Shift Virusstämmen ausgesetzt wurden,
zeigten statistisch signifikant geringere virale Titer und höhere
Überlebensraten verglichen mit Mäusen, die mit NP alleine oder einem
PBS-Placebo immunisiert waren.
MFG
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