These results were published on the website of the 61st annual meeting of the American Association for the Study of Liver Diseases (AASLD). The Dynavax vaccine (two doses over 4 weeks) displayed superior seroprotection in patients suffering from diabetes compared to Engerix-B (three doses over 24 weeks).
The data on 62 adult diabetics from the company’s previously reported multicenter late-stage study called PHAST (phase III Heplisav short-regimen trial) revealed that at 12 weeks 84% patients treated with Heplisav achieved seroprotection. However, none of the patients treated with Glaxo’s vaccine achieved similar results. The data revealed that at 28 weeks, 93% patients in the Heplisav arm achieved seroprotection as against 35% in the Engerix-B arm. The higher rate of seroprotection was displayed by Heplisav, despite patients in the Heplisav arm not being immunized beyond four weeks. However, patients in the Engerix-B arm received a third immunisation at 24 weeks.
Dynavax’s HBV vaccine is being evaluated in two late-stage studies. The continuity of studies was recently approved by the Data Safety Monitoring Board. One of them is a large-scale late-stage lot-to-lot consistency study. The large-scale study, which completed enrollment in May 2010, intends to show that Dynavax’s HBV vaccine is just as effective as Engerix-B eight weeks after the last active dose. The other study, whose enrollment is expected to be completed shortly, will evaluate Heplisav in patients with chronic kidney disease.
We currently have a Neutral recommendation on Dynavax, which is supported by a Zacks #3 Rank (short-term Hold rating).
DYNAVAX TECH CP (DVAX): Free Stock Analysis Report
GLAXOSMITHKLINE (GSK): Free Stock Analysis Report
Zacks Investment Research
