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Dynavax Reports Diabetic Subset Data From Modified Intent to Treat Analysis of the HEPLISAV Phase 3 Trial


Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the results of a prospective analysis of the diabetic subset population from its Phase 3 trial (HBV-16), showing the superiority of HEPLISAV vs. Engerix-B(R), at all measured time points. The modified intent to treat (MITT) analysis of adults with type II diabetes showed that HEPLISAV given as 2 doses over 4 weeks protected a significantly greater proportion of subjects in a shorter time and with longer-lasting protection than Engerix-B given as 3 doses over 24 weeks. The modified intent to treat (MITT) subpopulations included all diabetic subjects that had received at least one dose of any of the four HEPLISAV lots or Engerix-B and had at least one post vaccination immunogenicity result.

Posted-In: News FDA


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