Anthrax

Next clinical trial of VaxGen's anthrax vaccine delayed

Published in Health Business Week, December 8th, 2006

VaxGen, Inc. (VXGN.PK) received a clinical hold notification from the U.S.Food and Drug Administration (FDA) that will postpone the initiation of the company's second Phase II trial for its investigational anthrax vaccine, rPA102.

The FDA's Center for Biologics Evaluation and Research (CBER) said the hold notice was issued because data submitted to date by the company are insufficient to determine that the product is stable enough to resume clinical testing. In the notification, the agency expressed concerns that the vaccine's potency could decline during the immunization phase of the trial, potentially resulting in an uninterpretable outcome.

The...

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Source: Health Business Week (2006-12-08)

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