FDA lifts restriction of vaccine trial

May 30, 2013 at 4:24 PM
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ANNAPOLIS, Md., May 30 (UPI) -- The U.S. Food and Drug Administration has ended its hold on PharmAthene's proposed Phase II study of SparVax, a next-generation recombinant anthrax vaccine.

In a 2012 notice to PharmAthene, prior to the commencement of a proposed Phase II clinical trial of SparVax, the FDA requested additional stability data for both its engineering and GMP lots of U.S. manufactured Final Drug Product, as well as additional information about the intended stability indicating assays.

"We are very pleased by the FDA's thorough review of the SparVax stability data and its subsequent decision to allow our clinical trial to proceed," said Eric I. Richman, president and chief executive officer of PharmAthene.

"The U.S. government's requirement for a recombinant anthrax vaccine for the civilian Strategic National Stockpile is an important national security imperative that remains unfilled.

"Next-generation anthrax vaccines like SparVax, which employ modern vaccine technology, offer the potential for improved convenience, cost-effectiveness, more rapid immunity, and the ability for large scale rapid delivery."

SparVax is a recombinant protective anthrax vaccine being developed for pre- and post-exposure protection against anthrax infection. Earlier human trials suggested that the vaccine appears to be "well tolerated and immunogenic in humans," the company said.

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