PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger P...( ANNAPOLIS Md. Oct. 27 /- PharmAth...),Health

ANNAPOLIS, Md., Oct. 27 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE ALTERNEXT US: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that dosing of volunteers has begun in a U.S. Phase I clinical trial evaluating Protexia(R) for safety and tolerability in humans. Protexia(R), which is produced in the milk of transgenic goats, is a recombinant version of human butyrylcholinesterase (BChE), which has been shown to be effective in animal models in preventing toxicity from exposure to chemical nerve agents.

The randomized, placebo-controlled, third-party double-blind, dose escalating Phase I clinical trial will study Protexia(R) administered intramuscularly at one and two time points in healthy human volunteers. Approximately 32 subjects will participate in the study, comprised of healthy male and female volunteers between the ages of 18 and 55 years who are willing to give informed consent and are in general good health.

Under the study protocol, either Protexia(R) or a saline control will be administered in escalating doses to five groups of volunteers. Safety data through 14 days post-dosing will be evaluated prior to escalation to a higher dose. Subjects in four of the groups (comprised of six subjects each) will receive a single dose of Protexia(R) and participate in the trial for two and a half months. One group of eight subjects will receive a second dose of Protexia(R) approximately 72 days following the first dose and will participate in the study for approximately five months.

The primary endpoint of the study is an evaluation of the safety, tolerability, pharmacokinetics and immunogenicity of escalating single doses of Protexia(R) given intramuscularly in healthy human volunteers. The secondary endpoint will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of a second dose of Protexia(R) in one dose cohort.

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