FDA lifts clinical hold on anthrax vaccine program
PharmAthene, a biodefense company developing medical countermeasures against biological and chemical threats, said the FDA has lifted the clinical hold previously placed on a proposed phase II study of SparVax, a next generation recombinant anthrax vaccine.
"Anthrax has been identified as one of the foremost potential biological threats to the nation,” said Eric I. Richman, president and CEO. “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.”
The FDA acknowledged that PharmAthene had satisfactorily addressed all of its 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 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.