Dynavax Completes Phase I Immunization in Pediatric Ragweed Allergy Trial
BERKELEY, Calif., Jun 24, 2004 /PRNewswire-FirstCall via COMTEX/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative products to treat and prevent allergies, infectious diseases and chronic inflammatory diseases, today reported the successful completion of immunizations in a Phase I pediatric trial of its ragweed allergy immunotherapy product candidate, AIC. Only relatively minor and transitory local reactions at the injection site were reported, and no dose adjustments were necessary.
"The local reactions and adverse experience of AIC in this young population appeared to be even milder than those observed in the adult population, where the product has already been shown to be quite safe and well tolerated," said Dino Dina, M.D, President and Chief Executive Officer of Dynavax Technologies.
"The excellent tolerability of AIC thus far in the pediatric age group provides us with the ability to evaluate AIC in a larger segment of the target ragweed allergic population. Equally important, we believe these findings could permit us to explore early interventions with AIC in ragweed allergic individuals prior to the onset of severe symptoms and the development of asthma, with the goal of preventing the evolution of the disease into significant health and life-style compromising conditions. We hope in the future to test AIC therapy as a way to prevent the onset of severe allergic disease their serious sequelae such as chronic sinusitis and asthma," Dr. Dina added.
The pediatric trial is being conducted in 24 children between the ages of 9 and 17 with known ragweed allergy, as documented by medical history and a strongly positive skin test to ragweed allergen. Subjects were subdivided into three cohorts, with each cohort receiving gradually increasing doses of AIC.
The pediatric trial is part of Dynavax's larger AIC ragweed program being conducted in collaboration with Dynavax's partner, UCB Pharma. The AIC program includes an ongoing Phase II/III study in adults, with a blinded interim analysis to be made in late 2004 to assess safety and the appropriateness of commencing a one-year Phase III trial in early 2005.
About UCB Pharma
UCB Pharma is one of Europe's leading pharmaceutical companies. It is active in all the world's major markets, specializing in the fields of allergy and respiratory diseases and in treatments for disorders of the central nervous system. Among products developed by UCB Pharma are XYZAL® (levocetirizine), a novel antihistamine; ZYRTEC® (cetirizine hydrochloride), the world's most widely used second-generation antihistamine; and KEPPRA® (levetiracetam), a novel adjunctive therapy for the treatment of partial onset seizures associated with epilepsy. ZYRTEC® is a registered trademark of Pfizer, which markets ZYRTEC® in the U.S. under an agreement with UCB. With over 6,500 employees and operating in over 100 countries, UCB Pharma's global headquarters are in Brussels, Belgium. In 2003 it achieved a consolidated turnover of euro 1,463 million.
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. ISS are being developed in three separate indications: a ragweed allergy program, a Hepatitis B vaccine program in late stage clinical development, and an asthma program completing a Phase II exploratory trial.
Dynavax cautions you that statements included in this press release that are not a description of historical facts are 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, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its 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; and other risks detailed in the "Risk Factors" section of Dynavax's Annual Report on Form 10-K filed on March 30, 2004, and in the section titled "Additional Factors That May Affect Future Results" within Dynavax's quarterly report on Form 10-Q filed on May 12, 2004. 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
Dino Dina, M.D., President and Chief Executive Officer of Dynavax Technologies Corporation, +1-510-848-5100
http://www.dynavax.com