Dynavax presents further Ph III Heplisav data

29 April 2009

Dynavax Technologies presented additional Phase III data showing that the Heplisav hepatitis B vaccine met the primary endpoints in a Phase  III trial, at the annual meeting of the European Association for the  Study of Liver Disease in Copenhagen, Denmark.

The PHAST study seroprotection rate at the primary endpoint was 95% in  subjects receiving two doses of Heplisav at baseline and one month,  compared to 81% in patients receiving three doses of the vaccine  Engerix-B. At each time point, there was a statistically-significant  (p<0.0001) difference in the seroprotection rate for those receiving  Heplisav or Engerix-B.

As previously reported, safety results from this trial demonstrated the  safety profile of Heplisav and Engerix-B appeared similar. Subjects were  randomized three to one to receive Heplisav or Engerix-B.

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