Healthcare Industry News: HEPLISAV
News Release - December 20, 2006
Dynavax Initiates Pivotal Phase 3 Trial for HEPLISAV(TM), Hepatitis B VaccineCanadian Site First to Dose in Multi-National Trial
BERKELEY, Calif., Dec. 20 (HSMN NewsFeed) -- Dynavax Technologies Corporation (Nasdaq: DVAX ) announced today the initiation of a pivotal Phase 3 clinical trial of HEPLISAV, its hepatitis B virus (HBV) vaccine in Canada. Sites in the United States and in Europe are scheduled to participate in the study and are expected to begin dosing patients in early 2007. The multi- center Phase 3 trial, known as PHAST (Phase 3 HEPLISAV Short-regimen Trial), will compare a two-dose regimen of HEPLISAV administered at 0- and 1-month to the conventional three-dose regimen of Engerix-BŪ. The enrollment target of the study is 1,740 subjects, ages 11 to 55 years.
"In several previous clinical studies, HEPLISAV has been shown to provide seroprotection against hepatitis B faster and with fewer doses than conventional hepatitis B vaccines. Additionally, HEPLISAV has provided 100% seroprotection in all fully vaccinated patients, including those who are difficult-to-treat. We believe our drug's shorter, more convenient vaccination schedule and proven efficacy position HEPLISAV to significantly change the standard for HBV adult vaccination. Equally important, the initiation of the Canadian study sites reinforces our confidence in our regulatory strategy, and keeps us on track regarding the timing of our pivotal studies and our plans to file for product licensure," noted Dr. Eduardo Martins, Vice President, Clinical Development.
Dynavax anticipates that the trial will be completed in 2008 and intends to use the data to support registration of HEPLISAV. Previously reported clinical trial results have shown 100% seroprotection after two doses in subjects 18 to 39 years of age, and after three doses in subjects 40 to 70 years of age. Recently reported data from a Phase 3 study show that after three doses, HEPLISAV provided seroprotection to 100% of subjects versus 73.1% for Engerix-B (p < 0.0001), and that after two doses, HEPLISAV provided seroprotection to 98.5% of subjects versus 25% for Engerix-B (p< 0.0001).
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. 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 commercial quantities of the vaccine.
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent allergies, infectious diseases, 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 pipeline includes: TOLAMBA(TM), a ragweed allergy immunotherapeutic, for which a major safety and efficacy trial (DARTT) is currently underway, and that is in a supportive clinical trial in ragweed allergic children; HEPLISAV(TM), a hepatitis B vaccine in Phase 3; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2; and a therapy for metastatic colorectal cancer in Phase 1. Our pre- clinical asthma and COPD programs are partnered with AstraZeneca. NIH funds our preclinical work on a vaccine for influenza; Symphony Dynamo, Inc., funds our colorectal cancer trial and our preclinical programs in hepatitis B and C therapies. While the NIH and Symphony 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 potential safety and efficacy of HEPLISAV, whether successful results may be shown in additional clinical studies, whether HEPLISAV may show similar or supportive results in the Phase 3 clinical studies and the potential for HEPLISAV to 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, achieving the objectives of our collaborative and licensing agreements and obtaining regulatory approval for our products; the scope and validity of patent protection for our products; possible claims against us on the patent rights of others; competition from other companies; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K and 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
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