Dynavax Initiates Phase II/III Clinical Trial for Ragweed
Allergy Immunotherapy
Allergy Immunotherapy
Dynavax Initiates Phase II/III Clinical Trial for Ragweed Allergy Immunotherapy
BERKELEY, Calif., Feb. 25 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) announced today the start of a multi-site, phase II/III clinical trial to evaluate the safety and efficacy of its ragweed allergy immunotherapy product candidate, AIC. The two-year study will enroll 462 subjects at 30 allergy clinics throughout the Midwest and Eastern United States and will be conducted by Quintiles Transnational Corp., a leading pharmaceutical services organization. The clinical trial is being managed in collaboration with UCB Pharma, which will provide financial support according to a strategic partnering agreement Dynavax signed in early February 2004.
Prior to the 2004 ragweed season, subjects will receive a six-week regimen of either placebo or escalating doses of up to 30 micrograms of AIC. Some subjects will receive two additional booster shots of AIC prior to the 2005 ragweed season. The primary endpoint of the trial will be the change in nasal symptoms relative to placebo following the 2005 ragweed season. Secondary endpoints will be comparative medication use and quality of life parameters between AIC-treated subjects and those receiving placebo. An interim analysis will be performed at the end of the 2004 ragweed season.
About Dynavax
Dynavax Technologies 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. Dynavax's 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.
Note: This press release contains "forward-looking statements" within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements relating to the design, enrollment criteria and endpoints of the clinical trial. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Dynavax undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this release except as required by law.
SOURCE Dynavax Technologies Corporation