Tuesday, Dynavax Technologies Corp.(DVAX) said the experimental hepatitis B virus vaccine -- HEPLISAV, which it is co-developing with Merck, achieved its primary goals in a late stage clinical trial. The study compared HEPLISAV with Engerix-B -- a currently marketed hepatitis B virus vaccine.
HEPLISAV is being jointly developed by Dynavax and Merck for use in adults and in patients with end stage renal disease.
The multi-center study, which evaluated 2,427 subjects from 11 to 55 years of age in Canada and Germany, aimed to determine the proportion of subjects who developed protective antibodies to hepatitis B after administration.
In the study, a two-dose regimen of HEPLISAV was administered to patients at 0 and 1 month and a three-dose regimen of Engerix-B was administered at 0, 1 and 6 months.
About 95.1% of subjects who received two doses of HEPLISAV developed protective antibodies to hepatitis B when measured at 12 weeks compared to just 81.1% of subjects who received three doses of Engerix-B, when measured at 28 weeks, the company noted.
The company plans to present results of additional analyses from this trial in the future.
As previously disclosed, the FDA has placed a clinical hold on the two Investigational New Drug Applications for HEPLISAV that is still in effect.
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