FDA removes clinical hold on anthrax vaccine program

The U.S. Food and Drug Administration announced on Thursday that it has lifted a clinical hold placed on the proposed phase II of PharmAthene's SparVax.

Anthrax is an acute disease caused by a lethal bacterium called Bacillus anthracis. Most versions of the disease are lethal and are known to affect both humans and animals. Anthrax spores can be produced and used as a biological weapon.

Depending on how it is ingested, anthrax has different symptoms. If the spores are breathed in, cold or flu-like symptoms are common, which grow more and more severe and have the potential to be fatal. If the spores are eaten on something contaminated, which is the rarest form, some serious symptoms including vomiting of blood and diarrhea can occur. Anthrax can also come in contact with the skin and cause boil like lesions that tend to be less lethal than the other versions.

The clinical hold on SparVax has been in place since August 2012. At that time, the FDA asked PharmAthene to provide stability data for its engineering and GMP lots.

PharmAthene addressed all these issues, and in a letter sent to them, the FDA said the clinical hold has been lifted.

"We are very pleased by the FDA's thorough review of the SparVaxstability data and its subsequent decision to allow our clinical trial to proceed," Eric I. Richman, president and chief executive officer of PharmAthene, said. "Anthrax has been identified as one of the foremost potential biological threats to the Nation. 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."

SparVax is a next generation recombinant protective anthrax vaccine that can be used for protection before and after exposure to anthrax. In previous clinical trials, SparVax shows that human recipients tolerate the vaccine well.