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FDA delays PharmAthene anthrax study

PharmAthene Inc., of Annapolis, a biodefense company developing medical countermeasures against biological and chemical threats, announced that it has been notified by the Food and Drug Administration that its SparVax next-generation anthrax vaccine program has been placed on clinical hold.

No reason was given.

The FDA indicated that it will provide details of the basis for the clinical hold within 30 days.

PharmAthene had expected to begin a Phase II clinical study of the new vaccine by the end of the year but said it has not enrolloed any subjects to date.

This is the second clinical hold of the anthrax vaccine program; in May 2013 the FDA lifted a hold on the program that it had imposed in August 2012.