We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue to Study Completion
Product News

Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue to Study Completion

Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue to Study Completion
Product News

Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue to Study Completion


Want a FREE PDF version of This Product News?

Complete the form below and we will email you a PDF version of "Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue to Study Completion"

First Name*
Last Name*
Email Address*
Country*
Company Type*
Job Function*
Would you like to receive further email communication from Technology Networks?

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

Dynavax Technologies Corporation has announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 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, M.D., President and Chief Medical Officer, commented, "This DSMB review is an important milestone for our Phase 3 program. 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-center Phase 3 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.

Advertisement