Dynavax Completes Enrollment of Phase 3 Study of HEPLISAV-B(TM)
This large safety and immunogenicity study (known as HBV-23) is intended to provide an adequately-sized database of vaccinated subjects to enable the
"Concluding enrollment of HBV-23 is a major milestone in the path to potential approval of HEPLISAV-B. I am pleased with the team's efforts to complete this key phase of the trial three months ahead of schedule" said
HBV-23 is an observer-blinded, randomized, active-controlled trial. Adult subjects between the ages of 18 and 70 have been randomized in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of the control vaccine, Engerix-B®. Safety follow up will continue for 12 months following each subject's second vaccination. All study visits will be completed by October, 2015.
Additional details regarding HBV-23 are available at www.clinicaltrials.gov.
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, timing and sufficiency 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 a sufficient number of subjects enrolled in HBV-23 complete the study; 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 studies and manufacturing efforts are sufficient to support registration for commercialization of HEPLISAV-B; our ability to obtain additional financing to support the development and commercialization of HEPLISAV-B and our other operations; possible claims against us, including enjoining sales of HEPLISAV-B, based on the
patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the
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