Dynavax Reports Diabetic Subset Data From Modified Intent to Treat Analysis of the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40
- Of the 218 diabetics in the MITT population (179 HEPLISAV; 39 Engerix-B), the SPRs for HEPLISAV were superior to Engerix-B at weeks 8 through 52.
- At the prespecified comparison time points of week 12 for HEPLISAV and week 32 for Engerix-B, the SPR was 79% in the HEPLISAV group and 61% in the Engerix-B group.
- At week 12, the SPR was 79% in the HEPLISAV group and 11% in the Engerix-B
- At week 52, the SPR in the HEPLISAV group was 82% whereas the SPR in the Engerix-B group was 54% by week 52.
According to
Engerix-B® is a registered trademark of GlaxoSmithKline
About
Forward-Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. 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 successful clinical and regulatory development and approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process, including the outcome of pre-filing discussions with regulatory authorities; the Company's ability to obtain additional financing to
support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the
Contact:Michael Ostrach Vice President and Chief Business Officer 510-665-7257 Email Contact
Source:
News Provided by Acquire Media