Dynavax to Report New Heplisav Data In Diabetics
BERKELEY, CA, Oct 11, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today said that Dr. William L. Heyward, Vice President, Clinical Development, will make an oral presentation of new data from a subset of diabetes subjects evaluated as part of the company's previously reported multicenter, observer-blinded phase 3 study. The PHAST (Phase 3 HeplisAv Short-regimen Trial) study compared two doses of HEPLISAV (20ug HBsAg combined with 3000ug 1018 immunostimulatory sequence, Dynavax's Toll-like receptor agonist) given at 0 and 4 weeks (placebo at 24 weeks) to three doses of Engerix-B given at 0, 4 and 24 weeks. The presentation will be made in a late-breaker session on October 23, 2010 at the Annual Meeting of the Infectious Diseases Society of America (IDSA) in Vancouver, British Columbia.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has been studying the hepatitis B infection rates among diabetics and in long-term care facilities for quite some time. Later this month, ACIP will consider a recommendation for hepatitis B vaccination of adults with diabetes. Diabetics are at risk for hepatitis B infection and once infected, their disease frequently results in more severe chronic illness. Multiple outbreaks of hepatitis B among diabetics have occurred over the last several years in long-term care facilities, but prevention by vaccine has been complicated by the fact that diabetics are not routinely immunized and commonly do not respond well to currently licensed hepatitis B vaccines.
Dynavax first reported the results of its PHAST multi-center, observer-blinded Phase 3 study in August 2008. Of the 2101 subjects in the overall per protocol study population, the seroprotection rate of the HEPLISAV-treated group was 95 percent at week 12 and 81 percent at week 28 in the Engerix-B group, indicating noninferiority/superiority of HEPLISAV over Engerix-B. HEPLISAV is Dynavax's novel hepatitis B vaccine candidate, a TLR9 agonist; Engerix-B is a commercially available hepatitis B vaccine.
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties. 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 successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; 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; the company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the company based on the patent rights of others; 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. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the company's current periodic reports with the SEC.
Vice President and Chief Business Officer
Posted: October 2010