Dynavax Announces Full Enrollment of Phase II/III AIC Trial
BERKELEY, Calif., May 19 /PRNewswire-FirstCall/ -- 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 announced that its Phase II/III clinical trial of AIC for ragweed allergy, which started in late February 2004, has been fully enrolled. The double blind, placebo controlled study involves 462 subjects at 30 sites in the U.S. and will be completed over the next 18 months. The immunization schedule, consisting of six injections over six weeks, will be completed by June. The clinical trial is being conducted in collaboration with UCB Pharma, a European pharmaceutical company that markets XYZAL® and developed ZYRTEC®, the leading prescription anti-allergy drug worldwide. Dynavax and UCB signed a global licensing and commercialization agreement covering ragweed and grass allergy immunotherapies in February 2004.
The primary endpoint of the Phase II/III ragweed study will be nasal symptoms scores after the second ragweed season in the late summer and early fall of 2005, with secondary endpoints assessing symptoms, medication use and quality of life in both the first and second year. A blinded interim analysis will be made in late 2004 to assess safety and the appropriateness of commencing a one-year Phase III trial in early 2005.
"The collaboration with UCB has been very effective, with both organizations working diligently to advance our ragweed program," said Dr. Dino Dina, president and CEO of Dynavax. "The rapid enrollment of our ragweed trial, particularly given its size and stringent enrollment criteria, is an early indication of the level of interest that both investigators and patients have in this therapy. We believe that this will translate into a significant market opportunity for an improved treatment for seasonal allergic rhinitis caused by allergy to ragweed."
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 obligation to revise or update this news release to reflect events or circumstances after the date hereof.
SOURCE Dynavax Technologies Corporation
-0- 05/19/2004
/CONTACT: Dino Dina, M.D., President and Chief Executive Officer of
Dynavax Technologies Corporation, +1-510-848-5100/
/Web site: http://www.dynavax.com /
(DVAX)
CO: Dynavax Technologies Corporation; UCB Pharma
ST: California, Belgium
IN: MTC HEA BIO
SU: LIC
TX-GF
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4226 05/19/2004 07:00 EDT http://www.prnewswire.com