FDA CLEARS ANTHRAX VACCINE CANDIDATE



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Last Updated

28 May 2003

Source: Wall Street Journal, May 27, 2003

FDA Clears VaxGen's IND For Anthrax Vaccine Candidate

Clinical Development To Begin At Leading Medical Centers

DOW JONES NEWSWIRES

BRISBANE, Calif. -- VaxGen Inc. (VXGN) received Food and Drug Administration clearance for the investigational new drug application for its candidate anthrax vaccine.

In a press release Tuesday, the biopharmaceutical company said the approval allows it to begin clinical development of the vaccine, with the goal of producing an emergency stockpile for the U.S. government and licensing the product for commercial sales.

VaxGen plans to launch a phase I human clinical trial involving about 100 volunteers to evaluate the safety and efficacy of its candidate vaccine compared with the existing licensed anthrax vaccine.

The company will fund the trial through its contract with the National Institute of Allergy and Infectious Disease, part of the National Institutes of Health.

This contract seeks to develop an anthrax vaccine that is safe in humans, effective in animal inhalation challenge studies and requires no more than three injections. The contract calls for the vaccine to be made from recombinant Protective Antigen, or rPA, a protein known to reduce antibodies that neutralize anthrax toxins.

Last week, the NIAID requested proposals for advanced development of an rPA anthrax vaccine candidate. Deliveries under this contract are to include the manufacture of 3 to 5 million doses, as well as much of the preclinical and clinical testing needed for submission of a license application to the FDA.

VaxGen is already required under its existing NIAID contract to submit a plan for manufacturing 25 million doses in the case of an emergency under an active investigational new drug application.

The company also expects the Department of Health and Human Services or the Department of Homeland Defense to issue a separate contract for a stockpile of 25 million doses.

VaxGen plans to produce the vaccine candidate at its South San Francisco, Calif., facility if it wins either or both of the contracts.

The company's shares soared more than 91% to $6.39 in after-hours trading, according to Island ECN, after closing Tuesday at $3.34, up 20 cents, or 6.4%. The stock hit a 52-week high of $23.25 on Nov. 18 and a 52-week low of $2.11 on April 1.