Biotech Values

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DVAX - Phase 3 Heplisav trials cleared by DSMB

[At what point do you think the Heplisav hepatitis B program starts to look interesting? Passing this test is presumably a step in the right direction. If the drug pans out in Phase 3 on both an efficacy and safety front, and is approved by the FDA, any guesstimate on potential sales for a drug that could improve upon Engerix-B (#msg-37352876)?]

http://finance.yahoo.com/news/Dynavaxs-Two-Phase-3-HEPLISAV-iw-2205726790.html?x=0&.v=1

Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue Immunizations
Safety Assessment of First Group of Immunized Subjects Complete

BERKELEY, CA--(Marketwire - 04/27/10) - Dynavax Technologies Corporation (NASDAQ:DVAX - News) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV™ has assessed subject safety data for 1,548 subjects that received their first injection and 1,225 subjects that received a second injection, and determined that the studies may continue without modification of the existing protocols.

HEPLISAV is an innovative vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, one trial in adults 40 years and older, and a second trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit http://www.dynavax.com/.