PharmAthene was awarded a multiyear contract worth up to $213 million from the DoD U.S. Army Space and Missile Command for development of the its chemical nerve agent prophylaxis, Protexia®.
“Since our acquisition of Protexia last year, we have made rapid progress defining a viable manufacturing process for commercial-scale production and demonstrated proof-of-concept showing protection with Protexia against highly lethal doses of nerve agent exposure,” points out David P. Wright, president and CEO.
Under the contract, PharmAthene will conduct and oversee all product development activities. The initial stage of development, for which $34.7 million has been allocated, includes manufacturing process development, preclinical safety and toxicity testing, submission of an IND application, and initiation of a Phase I trial.
The government may exercise its option to fund additional development activities once the Phase I trial is successfully completed, leading to FDA licensure. The DoD also has the option to procure an initial 90,000 doses of Protexia.
The Protexia contract was awarded through a full and open competitive solicitation seeking novel second-generation prophylactics to prevent and treat poisoning in humans from organophosphorus (OP) nerve agents, such as sarin gas, soman, tabun, and VX, according to PharmAthene. Protexia is a form of recombinant human butyrylcholinesterase (rBChE), a potent OP scavenger protein produced in the milk of transgenic goats.
“Preclinical studies suggest that in contrast to currently available treatments, rBChE can provide protection against both the physiological and neurological toxicities associated with nerve agent poisoning,” states Solomon Langermann, Ph.D., vp and CSO. “In addition, our proprietary manufacturing method enables substantially larger production yields than what is possible with human plasma-derived BChE, suggesting that when developed, Protexia can adequately fulfill the U.S. military and civilian stockpile requirements.”