Dynavax Announces Second Independent DSMB Recommendation to Continue Phase 3 Study of HEPLISAV-B(TM)
The second DSMB review included safety data for all enrolled subjects collected through the data cut-off in February. As of the cut-off, all continuing subjects had received the second immunization (which was the last active dose for HEPLISAV-B subjects) and all had reached at least 5 months follow-up after the first immunization. The DSMB reviewed unblinded tables and listings presenting key safety data. Based on this review, the panel recommended continuing HBV-23 with no change to the study.
One additional prespecified DSMB review will occur during the conduct of HBV-23. All study visits will be completed by October, 2015.
About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
About
Forward-Looking Statements
This press release contains "forward-looking" statements, including expectations for the conduct and timing of HBV-23. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether HBV-23 can be completed as expected and whether successful clinical and regulatory development and review and approval of HEPLISAV-B and our process for its manufacture can occur without significant delay or additional studies and other risks detailed in the "Risk Factors" section of our current periodic reports with the
Contact:
Chief Financial Officer
510-665-7257
Email Contact
Source:
News Provided by Acquire Media