Dynavax Technologies Corporation announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing phase III trials for Heplisav has completed its planned safety assessments. The DSMB determined that the studies may continue without protocol modification, and that no other formal meetings of the DSMB are required.
Tyler Martin, MD, president and chief medical officer, commented, “This DSMB review is an important milestone for our phase III programme. All subjects in our large safety and lot-to-lot consistency trial randomized to Heplisav are now eight months past their last dose. It would be unlikely to see a serious adverse event related to Heplisav at this time. Based on our progress, we look forward to completing the trials as planned and filing our BLA by the end of 2011.”
The DSMB reviewed safety data from two ongoing multi-centre phase III trials evaluating Heplisav, the first a lot-to-lot consistency trial in adults 40 years and older, and the second a trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
Heplisav is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two phase III studies that are directed toward fulfilling licensure requirements in the US, Canada and Europe. Enrollment has been completed for both studies. In a completed pivotal phase III trial, Heplisav demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to Heplisav and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases.