Dynavax Announces Third Independent DSMB Recommendation to Continue Phase 3 Study of HEPLISAV-B(TM) and Updates Financial Status
The third DSMB review included safety data for all enrolled subjects collected through the data cut-off in June. As of the cut-off, all continuing subjects who had received the second immunization (which was the last active dose for HEPLISAV-B subjects) had reached at least 8 months of the requisite one year follow-up after the second immunization. The DSMB reviewed unblinded tables and listings presenting key safety data. Based on this review, the DSMB recommended continuing HBV-23 with no change to the study.
Over 2,200 subjects have completed their final study visit and all study visits for HBV-23 are expected to be completed by
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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.
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Forward-Looking and Cautionary Statements
This press release contains "forward-looking" statements, including expectations for the conduct and timing of HBV-23 and financial projections. 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, whether the endpoints of the study will be achieved and the final results otherwise be satisfactory, 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, whether our financial resources will be adequate without the need to obtain additional financing and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the
Projected cash, cash equivalent and marketable securities amounts stated above are preliminary, unaudited, subject to change upon completion of our quarterly review, and may differ from what will be reflected in our consolidated financial statements. Additional information and disclosures would be required for a more complete understanding of our financial position and results of operations. Information on
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