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news.PharmAthene has completed the initial pharmacokinetic testing of Protexia, the company's broad spectrum chemical nerve agent prophylaxis.
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The pharmacokinetic (PK) studies demonstrated that Protexia had a half life of approximately four days in primates and three days in rodents when administered by intramuscular injection. These data compare favorably with what was predicted for the drug’s PK profile in these animal species.
The PK studies were conducted in two animal species and used the final pegylated version of rBChE for the first time. In general, the conjugation of proteins with polyethylene glycol (PEG) has been shown to decrease immunogenicity, increase circulating serum half-life and increase stability of recombinant proteins. The data from these studies confirm that the specific PEG chosen for conjugation to rBChE will significantly improve the half-life of the protein in vivo.
John Troyer, senior program director for Protexia, said: “Having successfully completed the PK studies, we are on target to complete our toxicology studies and file the investigational new drug application for Protexia in the third quarter of 2008. We expect to commence Phase I human safety testing of Protexia in the fourth quarter.”