PharmAthene, Inc. PIP, a biodefense company developing medical countermeasures against
biological and chemical threats, announced today that the U.S. Food and Drug
Administration (FDA) has lifted the clinical hold previously placed on a
proposed Phase II study of SparVax^®, a next generation recombinant anthrax
vaccine.
In a letter to the Company, the FDA acknowledged that PharmAthene had
satisfactorily addressed all of the Agency's clinical hold issues and that
consequently, the clinical hold had been lifted, effective immediately.
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 both its engineering and GMP lots of U.S. manufactured Final Drug
Product, as well as additional information about the intended stability
indicating assays.
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