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Patient Enrollment Completed for Phase 2 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(R) and developed ZYRTEC(R), 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."

Source: Dynavax Technologies

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