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Re: Tuff-Stuff post# 50193

Monday, 03/02/2015 5:46:55 PM

Monday, March 02, 2015 5:46:55 PM

Post# of 53906
DVAX<Oversight board recommends continuing Heplisav-B Phase 3 trial

After completing its second prespecified review of safety data from the Phase 3 trial evaluating Dynavax Technologies' (NASDAQ:DVAX) hepatitis B vaccine candidate, Heplisav-B, the independent Data and Safety Monitoring Board (DSMB) recommends that the study continue unchanged.
The second DSMB review included safety data for all subjects through the February data cut-off date. All continuing subjects had received the second immunization (the last active dose of the vaccine) and all reached at least five months follow-up after the first immunization.
The DSMD will review the safety data a third and final time before the end of the trial. All study visits will be completed by October.
Heplisav-B combines a toll-like receptor 9 (TLR9) agonist with hepatitis B surface antigen to elicit an immune response after just two doses. A TLR9 agonist is an adjuvant which boosts the immune system.

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