Vaxgen says Anthrax vaccine trial delayed
CHICAGO, Nov 3 (Reuters) - Vaxgen Inc. (VXGN.PK: Quote, Profile, Research) said on Friday U.S. regulators ordered the company to delay the start of a second mid-stage clinical trial of its anthrax vaccine.
The U.S. Food and Drug Administration issued the hold notice because data submitted to date was not sufficient to prove the product was stable enough to resume clinical testing, the company said.
Vaxgen said the FDA expressed concern that the vaccine would lose potency, making results impossible to interpret.
The company said the delay was not related to side effects in people or issues with early studies.
http://today.reuters.com/news/articleinvesting.aspx?type=governmentFilingsNews&storyID=2006-11-03T133115Z_01_WEN9072_RTRIDST_0_HEALTH-VAXGEN-URGENT.XML
The U.S. Food and Drug Administration issued the hold notice because data submitted to date was not sufficient to prove the product was stable enough to resume clinical testing, the company said.
Vaxgen said the FDA expressed concern that the vaccine would lose potency, making results impossible to interpret.
The company said the delay was not related to side effects in people or issues with early studies.
http://today.reuters.com/news/articleinvesting.aspx?type=governmentFilingsNews&storyID=2006-11-03T133115Z_01_WEN9072_RTRIDST_0_HEALTH-VAXGEN-URGENT.XML
