Dynavax Technologies Corporation

Dynavax Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine

Published in Pharma Law Weekly, September 22nd, 2009

Dynavax Technologies Corporation (Nasdaq:DVAX) announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease. HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.

As a result of the FDA's decision, Dynavax expects to initiate a Phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.

"The...

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Source: Pharma Law Weekly (2009-09-22)

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