PharmAthene Inc. (PIP) has received notification from the U.S. Food and Drug Administration or FDA that its SparVax rPA anthrax vaccine program has been placed on clinical hold. The Agency indicated that the company would get a letter containing the details of the basis for the clinical hold within 30 days.
The company, during this period, would continue to provide the agency with analytical data from its recently produced GMP lot of material. The trial, which was expected to commence by the year end, has not enrolled any subjects to date and accordingly, there have been no adverse events reported.
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