BERKELEY, Calif., July 12 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation announced today the completion of enrollment of its Phase 3 pivotal clinical trial of HEPLISAV(TM), its novel hepatitis B virus (HBV) vaccine. Dynavax's U.S. safety and immunogenicity study - a second key clinical trial designed to support the licensure of HEPLISAV - is expected to complete enrollment before the end of this month. The multi-center pivotal Phase 3 trial in Canada and in Germany has enrolled over 2,000 subjects, as planned. The data from both trials, plus lot-to-lot consistency trials scheduled to begin in the second half of 2007, will contribute to a safety database of approximately 4,000 subjects for a planned BLA submission in 2008.
According to President and Chief Executive Officer Dino Dina, M.D., "By enrolling over 700 subjects at the German sites in only three weeks and 1,400 in Canada since December, we are one step closer to our goal of a BLA submission in the second half of 2008."
The multi-center Phase 3 pivotal trial, known as PHAST (Phase 3 HeplisAv Short-regimen Trial) began in Canada in late 2006 and in Germany on June 14, 2007. This trial enrolled subjects 11 through 55 years of age, and compares a two-dose regimen of HEPLISAV administered at 0 and 1 month to the conventional three dose regimen of Engerix-B marketed by GlaxoSmithKline.
In the U.S. study, consistent with the PHAST trial, subjects are receiving a two-dose regimen of HEPLISAV, at 0 and 1 month. The primary safety endpoint of this trial will be measured four weeks after the second dose.
The lot-to-lot consistency study, planned to start later this year, will compare three consecutive lots of HEPLISAV manufactured at Dynavax Europe. Approximately 2,000 subjects will be enrolled in this trial in the U.S., Canada, and Germany.
About HEPLISAV
Dynavax's HBV vaccine, HEPLISAV, is based on its proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to stimulate an innate immune response. HEPLISAV combines ISS with HBV surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection. Previously reported clinical trials results have shown 100% seroprotection after two doses in subjects 18 to 39 years of age, and after three doses in difficult-to-immunize subjects 40 to 70 years of age.
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 the initiation of clinical trials for HEPLISAV, the potential timing of the initiation of clinical studies and planned BLA filing, the potential safety and efficacy of HEPLISAV and the potential for HEPLISAV to meet regulatory requirements and achieve clinical and commercial success. 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.
Dynavax Technologies CorporationCONTACT: Melissa Malhame, HEPLISAV Project Leader of Dynavax TechnologiesCorporation, +1-510-665-7261, MMalhame@dynavax.com
Web site: http://www.dynavax.com//
