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news.The Data Safety Monitoring Board (DSMB) established for Dynavax Technologies' two ongoing Phase 3 trials evaluating Heplisav, has completed its planned safety assessments.
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The DSMB concluded that the studies may continue without protocol modification, and that no other formal meetings of the DSMB are needed.
The DSMB reviewed safety data from two ongoing multi-centre Phase 3 trials evaluating Heplisav.
The first Phase 3 trial is a lot-to-lot consistency trial in adults 40 years and older, while the second Phase trial is being conducted in chronic kidney disease patients.
Dynavax president and chief medical officer Tyler Martin said that based on the progress, the company looks forward to completing the trials as planned and filing the BLA by the end of 2011.
The DSMB consists of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.