FDA PLACES CLINICAL HOLD ON VAXGEN'S ANTHRAX VACCINE TRIAL

VaxGen announced it has received a clinical hold notification from the 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 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 notification is not related to any adverse event or preclinical finding related to the vaccine, according to the company. VaxGen said will meet with the FDA to discuss approaches to satisfying the agency's requirements so that the trial can begin.

Results of a Phase I clinical trial of rPA102 were published in the August issue of the medical journal Vaccine. HHS has awarded VaxGen an $878 million contract to provide 75 million doses of anthrax vaccine for the Strategic National Stockpile.