PharmAthene have announced that the FDA has lifted the clinical hold previously placed on the Phase II study of it's next generation anthrax vaccine, SparVax. The FDA had originally placed a hold on the trial back in August 2012, requesting that PharmaAthene "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". The FDA has acknowledged that PharmAthene has now satisfactorily addressed all of these hold issues, and as such the lift on the clinical hold will be effective immediately.
“We are very pleased by the FDA’s thorough review of the SparVaxÂ® stability data and its subsequent decision to allow our clinical trial to proceed,” said Eric I. Richman, President and Chief Executive Officer. SparVax is a next generation recombinant protective (rPA) anthrax vaccine for pre- and post-exposure protection against anthrax infection. Phase I and II clinical trials with the vaccine suggest it to be well tolerated and immunogenic in humans. "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," added Mr Richman. "Next-generation anthrax vaccines like SparVaxÂ®, 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 go-ahead for SparVax to move into Phase II brings it up against another rPA anthrax vaccine also in Phase II trials, Emergent BioSolutions' PreviThrax. Emergent is also the manufacturer of BioThrax, currently the only FDA-approved anthrax vaccine. Both SparVax and PreviThrax rPA vaccines will be looking to improve on BioThrax and be useful both before and after an anthrax infection.
Biodefense vaccine development was discussed at the World Vaccine Congress & Expo USA 2013 (Biodefense vaccines – overview, stockpiling and regulation). If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Asia 2013, 17-20 June 2013, Singapore.
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