FDA puts PharmAthene's SparVax program on clinical hold

The U.S. Food and Drug Administration has placed PharmAthene, Inc.'s SparVax rPA anthrax vaccine program on clinical hold.

The FDA said that it will deliver a letter with details of the 30 day hold. PharmAthene will continue to provide the agency with analytical data from its recently produced GMP lot of material during the 30 day period. The clinical study was expected to begin at the end of the year, though it has not enrolled any subjects to date, the Sacramento Bee reports.

PharmAthene, Inc., is a biodefense company developing countermeasures against biological and chemical threats. PharmAthene's lead product development programs including SparVax, which is a second generation recombinant protective antigen anthrax vaccine. The company also created recombinant BChE, a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents. Valorim is a fully human monoclonal antibody for the prevention and treatment of anthrax infection.

Additionally, pursuant to a final judgment issues May 31 from the Delaware Court of Chancery, PharmAthene is entitled to 50 percent of the net profits over 10 years from all sales of SIGA Technologies' ST-246, a novel smallpox antiviral agent being developed by SIGA for the treatment and prevention of morbidity and mortality associated with exposure to the causative agent of smallpox, and related products, once SIGA receives the first $40 million in net profits from sales of ST-246®, the Sacramento Bee reports.