PharmAthene, Inc. (PIP), a biodefense company developing medical countermeasures against biological and chemical threats, Thursday said the U.S. Food and Drug Administration has lifted the clinical hold placed on a proposed Phase II study of SparVax, a next generation recombinant anthrax vaccine.
The clinical hold was enacted in August 2012, prior to the commencement of a proposed Phase II clinical trial of SparVax. In its original notification to the company, the FDA requested that PharmAthene provide additional stability data for its engineering and GMP lots of U.S. manufactured Final Drug Product, as well as additional information about the intended stability indicating assays.
The FDA has now acknowledged in a letter that PharmAthene satisfactorily addressed all its clinical hold issues and that consequently, the clinical hold had been lifted, effective immediately.
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