Navigation Links
Dynavax's HEPLISAV(TM) Hepatitis B Vaccine Maintains Full Immunogenicity at 50 Weeks in Phase 3 Trial
Date:9/19/2007

In Difficult-to-Immunize Population, Demonstrates Superior Long-Term

Seroprotection Compared to Conventional Vaccine

BERKELEY, Calif., Sept. 19 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) announced today that the seroprotection of HEPLISAV at 50 weeks after the first vaccination remained at 100% while the seroprotection of the comparator, GlaxoSmithKline's Engerix-B(R); vaccine declined.

The data show that after three doses, HEPLISAV provided seroprotection (anti-HBsAg antibodies greater than or equal to 10 mIU/mL) to 100% of subjects versus 68.6% for Engerix-B (p < 0.0001) as measured at 50 weeks.

These data were reported in a poster at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, IL. Primary endpoint data from this Phase 3 study in a difficult-to-immunize population of older adults were reported in November, 2006. The primary endpoint is seroprotection four weeks after the third vaccination.

According to Eduardo Martins, M.D., D.Phil., Vice President, Clinical Development, "These results demonstrate HEPLISAV's long-term superior immunogenicity over conventional hepatitis B vaccine as measured at 50 weeks. These data confirm earlier clinical studies showing that HEPLISAV has superior immunogenicity and comparable tolerability to Engerix-B. The overall results suggest that HEPLISAV elicits a faster immune response, higher rates of seroprotection and a more durable immune response than conventional vaccine."

The Phase 3 trial enrolled more than 400 seronegative subjects, 40 to 70 years of age, at study sites in Singapore, Korea and the Philippines. One group of subjects received three doses of Dynavax's HBV vaccine; the other group received three doses of Engerix-B.

Dynavax reported in mid-July 2007, that an international Phase 3 trial in Europe and Canada had completed enrollment. Data from the pivotal Phase 3 trial plus lot-to-lot consistency trials will contribute to a safety database of approximately 4,000 subjects for a planned BLA submission in 2008. Dynavax's HBV vaccine is based on its proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to stimulate an innate immune response. Dynavax's HBV vaccine combines ISS with HBV surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection. Dynavax indicates that as a result of its acquisition of Rhein Biotech in April 2006, the company has secured manufacturing capabilities in Dusseldorf, Germany for producing both clinical and initial commercial quantities of the hepatitis B surface antigen component of the vaccine.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Our product candidates include: HEPLISAV, a hepatitis B vaccine in Phase 3; TOLAMBA(TM), a ragweed allergy immunotherapy; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. The National Institutes of Health (NIH) partially funds our preclinical work on a vaccine for influenza. Symphony Dynamo, Inc. (SDI) funds our colorectal cancer trials and our preclinical hepatitis C therapeutic program. While the NIH and SDI provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com.

This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about clinical trials for HEPLISAV, the potential timing of the planned HEPLISAV BLA submission and the superiority of 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 difficulties or delays in development, initiation and completion of clinical trials, the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; achieving our collaborative and licensing agreement objectives and obtaining regulatory approval; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.


'/>"/>
SOURCE Dynavax Technologies Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Second Phase III Study Evaluating Gileads Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
2. Second Phase III Study Evaluating Gileads Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
3. Anadys Pharmaceuticals Nominates ANA598, a Small-Molecule, Non-Nucleoside Inhibitor of The NS5b Polymerase, as a Candidate for Clinical Development in Chronic Hepatitis C Virus Infection
4. Valopicitabine Combined with Standard of Care Cleared Hepatitis C Virus in 72% of Patients Who Completed 12 Weeks of Treatment in a Phase II Trial
5. Phase III Study Evaluating Gileads Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
6. Pegasys Study Authors Conclude that Patients Successfully Treated for Hepatitis C Can be Considered Cured
7. Intarcia Therapeutics Announces Presentation of Final Results From a Phase 2 Combination Study for the Treatment of Hepatitis C at the Digestive Disease Week Conference
8. Baraclude (Entecavir) Treatment Demonstrated Greater Viral Load Reduction Compared to Adefovir at 48 Weeks in Study of Antiviral-Naive Chronic Hepatitis B E-Antigen Positive Patients
9. InterMune Presents Research on ITMN-191 in Hepatitis C at Digestive Disease Week Meeting
10. Data Suggest that Pegasys May be an Option in Hepatitis C Patients Unable to Tolerate Peg-Intron
11. Schering-Plough Announces Hepatitis C Data Presentations at Digestive Disease Week (DDW) 2007 Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2017)... 2017 SW Safety Solutions, Inc., the industry,s ... the release of the latest advancement in workplace single-use ... of leading edge nitrile glove technology features SW,s patent ... tactile grip on wet and oily surfaces and the ... and a suite of other advanced SW technologies, the ...
(Date:4/21/2017)... , April 21, 2017 Halo Labs announces ... biopharmaceutical particle analysis system called the Horizon at PEGS ... 1st. The new system analyzes sub visible particulate matter ... rapid particle screening as early as candidate selection and ... leading biopharma contract research organization Elion Labs ...
(Date:4/20/2017)... Texas , April 20, 2017  Vivify Health, ... mobile devices, has been awarded a very significant patent ... via EMRs to continual care via digital health.  This ... key intellectual property and further secures Vivify,s position as ... launched in 2009, was the first company to apply ...
Breaking Medicine Technology:
(Date:4/25/2017)... ... April 25, 2017 , ... A recent report from ... performance for the 2015-16 school year across Wisconsin’s public schools, charter schools, and ... important patterns in student test score performance, the report’s limited analyses fail to ...
(Date:4/25/2017)... , ... April 25, 2017 , ... Lake Park Dental ... by using Invisalign® in Lutz, FL. With the help of this highly-effective, ... aesthetics with fewer potential complications, more discretion and less pain. , Drs. Sarah ...
(Date:4/25/2017)... ... April 25, 2017 , ... As pharmaceutical companies are ... help with process innovation in drug formulation and manufacturing. CoreRx offers its ... analytical equipment in support of their development and manufacturing goals. , The ...
(Date:4/25/2017)... ... , ... Back Pain Centers of America (BPC), which connects people ... their area, announces the launch of a new and proprietary customer relationship management (CRM) ... reputable physicians to help them with back or neck pain and helps to match ...
(Date:4/25/2017)... Plains, NJ (PRWEB) , ... April 25, 2017 , ... Saad B. Chaudhary, MD is ... the treatment of acute or chronic problems, I focus on preventative care with all my ... If you have any questions, always feel free to contact my office and my trained ...
Breaking Medicine News(10 mins):