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Phase 2 study shows Genelabs-developed hepatitis E vaccine HEV003 is 96% effective against disease
By E. Janene Geiss
Philadelphia, Dec. 13 - Genelabs Technologies, Inc. said the results of a phase 2 clinical trial of HEV003, a vaccine designed to prevent infection of the hepatitis E virus, indicate the vaccine was 96% effective in preventing disease caused by the virus, according to an 8-K filing with the Securities and Exchange Commission.
Company officials said in the filing that the study had a total of 69 confirmed cases of hepatitis E occurring among individuals who had received all three doses of the investigational HEV vaccine or the placebo.
Of these cases, 66 occurred among placebo recipients and three occurred among vaccine recipients.
The data also indicated the vaccine was well-tolerated with no significant adverse safety events attributed to the vaccine during the course of the study.
These results were presented Dec. 12 by representatives of the Walter Reed Army Institute of Research at the American Society of Tropical Medicine and Hygiene's annual meeting.
The study was conducted by the Walter Reed institute, the Royal Nepal Army, the U.S. National Institutes of Health and GlaxoSmithKline Biologicals under a U.S. Investigational New Drug exemption, the filing said.
Genelabs Technologies, Inc. did not participate in the study or the presentation, the filing said.
GlaxoSmith Kline developed the vaccine under a license from Genelabs, the filing said.
In November 2004, Genelabs received a $750,000 milestone payment from the company based on the preliminary results of the study, the filing said.
Genelabs is a Redwood City, Calif., biopharmaceutical company.
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