Dynavax to Present Data on Phase 2/3 Clinical Trial of HEPLISAV(TM) Hepatitis B Vaccine at ICAAC 2005
BERKELEY, Calif., Dec. 7 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) announced that safety and efficacy data from the company's Phase 2/3 clinical trial of HEPLISAV, its ISS-based hepatitis B vaccine, compared to GlaxoSmithKline's Engerix-B® vaccine in an older adult population will be presented in a poster session at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), in Washington, DC.
The data will be presented by Dr. Seng Gee Lim, Department of Medicine, Division of Gastroenterology, National University Hospital, Singapore.
The poster is entitled, "Recombinant Hepatitis B Surface Antigen (rHBsAg) Co-administered with an Immunostimulatory Phosphorothioate Oligonucleotide (1018 ISS) Provides Superior Protection in Older Subjects." The Phase 2/3 trial was conducted by Dr. Lim and by Dr. Chow Wan Cheng of the Singapore General Hospital. The poster session, number 87, is scheduled for Saturday, December 17, 2005, 10:00-11:30 am Eastern Time, in Exhibit Hall B of the Washington Convention Center. The Dynavax poster number is 221. The poster will be available on the ICAAC website at the time of the poster session.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs 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. Dynavax's pipeline includes: TOLAMBA™, a ragweed allergy immunotherapeutic, currently in a large-scale Phase 2/3 clinical trial and in a supportive clinical trial in ragweed-allergic children; HEPLISAV™, a hepatitis B vaccine that is currently in a pivotal Phase 3 clinical trial; a cancer therapy currently in a Phase 2 clinical trial; and an asthma immunotherapeutic that has shown preliminary safety and pharmacology in a Phase 2a clinical trial.
Dynavax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the therapeutic and commercial potential of HEPLISAV, its HBV vaccine; statements concerning the company's other clinical programs and its ability to demonstrate the potential of its ISS technology. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward- looking statements should not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Dynavax's business including, without limitation, risks relating to: the ability of the company to demonstrate safety and effectiveness of its HBV vaccine in Phase 3 clinical trials; the progress and timing of initiating its Phase 3 clinical program in HBV; the ability of the company to develop and implement effective commercial strategies for its HBV vaccine; the progress and timing of clinical trials for the company's other products in development; difficulties or delays in developing, testing, obtaining regulatory approval of, producing and marketing its HBV and other products; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to maintain effective financial planning and internal controls; and other risks detailed in the "Risk Factors" sections of Dynavax's Annual Report on Form 10-K filed on March 18, 2005, Dynavax's quarterly report on Form 10-Q filed on November 14, 2005, and Dynavax's Prospectus Supplement filed on October 11, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Dynavax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
SOURCE Dynavax Technologies Corporation
12/07/2005
CONTACT: Jane M. Green, PhD, Vice President, Corporate Communications of
Dynavax Technologies Corporation, +1-510-665-4630, or jgreen@dvax.com
Web site: http://www.dynavax.com
(DVAX)
12/07/2005 16:00 EST http://www.prnewswire.com