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|PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger Protexia(R)|
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.
"The initiation of patient enrollment in the Phase I study for Protexia(R) is a significant milestone for PharmAthene as it represents continued progress in the development of this important product candidate. The development of Protexia(R) is currently being funded by a significant advanced development and procurement contract from the Department of Defense, which is seeking novel recombinant bioscavengers for prophylaxis against nerve agent poisoning," stated David P. Wright, President and Chief Executive Officer for PharmAthene.
"Preclinical studies suggest that Protexia(R) used as a prophylactic against nerve agents might offer important benefits over medical countermeasures for nerve agent poisoning," continued Mr. Wright. "Studies in animals suggest that Protexia(R) might prevent the neurological toxicity and cognitive impairment associated with exposure to nerve agents, which currently approved countermeasures are not able to adequately treat. In addition, because it is not derived from human plasma, we avoid issues associated with viral transmission. Given our proprietary manufacturing method, which enables substantially larger production yields than what is possible with human plasma-derived BChE, if successfully developed, Protexia(R) could adequately fulfill U.S. military and civilian stockpile requirements."
In September 2006 PharmAthene was awarded a multi-year contract valued at up to $219 million from the Department of Defense (DoD) U.S. Army Space and Missile Command, for advanced development of Protexia(R). Under the contract, PharmAthene is responsible for the conduct and oversight of all product development activities. The initial stage of development, for which $40.5 million has been allocated, includes manufacturing process development, preclinical safety and toxicity testing, submission of an Investigational New Drug (IND) Application with the United States Food and Drug Administration (FDA), and conduct of a Phase I clinical trial. Following successful completion of the Phase I trial, the government, at its discretion, may exercise its option to fund additional development activities beyond the initial $40.5 million, leading to FDA licensure. The contract also provides the DoD with the option to procure an initial 90,000 doses of Protexia(R).
Protexia(R), which is produced in the milk of transgenic goats, is a recombinant version of human butyrylcholinesterase (BChE), a naturally occurring protein found in minute quantities in blood (2 mg/liter). BChE functions as a natural bioscavenger, like a sponge, to absorb and degrade organophosphate poisons (e.g. nerve agents) before they cause neurological damage. Protexia(R) is being developed as a pre- and post-exposure therapy for casualties on the battlefield or civilian victims of nerve agent attacks. Nerve agents belong to a class of compounds known as organophosphate (OP) agents. OP nerve agents, such as sarin gas, soman, tabun or VX, enter the blood stream via inhalation or absorption through the skin. The nerve agents travel in the circulatory system to the brain and muscles causing the nerves to become over-stimulated which lead to massive convulsions and death in severe cases.
About PharmAthene, Inc.
PharmAthene was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead product development programs include:
-- SparVax(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine -- Third generation rPA anthrax vaccine -- Valortim(R) - a fully human monoclonal antibody for the prevention and treatment of anthrax infection -- Protexia(R) - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents -- RypVax(TM) - a recombinant dual antigen vaccine for plague For more information about PharmAthene, please visit www.PharmAthene.com.
Statement on Cautionary Factors
Except for the historical information presented herein, matters discussed may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; "should"; or similar statements are forward-looking statements. PharmAthene disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risk associated with the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates, unexpected funding delays and/or reductions or elimination of U.S. government funding for one or more of the Company's development programs, the award of government contracts to our competitors, unforeseen safety issues, unexpected determinations that these product candidates prove not to be effective and/or capable of being marketed as products, as well as risks detailed from time to time in PharmAthene's Forms 10-K and 10-Q under the caption "Risk Factors" and in its other reports filed with the U.S. Securities and Exchange Commission (the "SEC"). In particular, at this point there can be no assurance that the Phase I clinical trial will meet its end points for safety, tolerability, pharmacokinetics and immunogenicity, or that Protexia(R) will ever be shown to be safe and effective and approved by regulatory authorities for commercial use in humans. Significant additional non-clinical animal studies, human clinical trials, and manufacturing development work remain to be done under this program. Copies of PharmAthene's public disclosure filings are available from its investor relations department and our website under the investor relations tab at www.pharmathene.com.
SOURCE PharmAthene, Inc. -0- 10/27/2008 /CONTACT: Stacey Jurchison of PharmAthene, Inc., +1-410-269-2610, JurchisonS@PharmAthene.com / /Web site: http://www.pharmathene.com/ (PIP) CO: PharmAthene, Inc. ST: Maryland IN: HEA MTC SU: TRI CS-WB -- NEM114 -- 6323 10/27/2008 15:21 EDT http://www.prnewswire.com