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"We continue to be pleased by the strong support we have received from theDepartment of Defense in the advancement of our biodefense programs," saidDavid P. Wright, President and Chief Executive Officer. "The appropriationsfunding announced today is in addition to a previously announced multi-yearcontract from the Department of Defense U.S. Army Space and Missile Commandfor advanced development of Protexia(R). This contract is valued at up to$219 million, provided that certain milestones are achieved, and all contractoptions and extensions are exercised by the government."
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"We are also grateful to Maryland's U.S. Senator Benjamin Cardin, who hasbeen very supportive and committed to our success in developing biodefensevaccines and therapeutics to protect America's citizens and militarypersonnel," continued Mr. Wright. "Senator Cardin has been a strong advocatefor promoting the growth of technology-focused industries within Maryland andunderstands the importance of supporting our Nation's biodefense industry."
Protexia(R), a recombinant pegylated version of humanbutyrylcholinesterase (BChE), is being developed as a pre-exposureprophylactic and post-exposure therapy for military and civilian victims ofnerve agent attacks.
"We have obtained promising data in animal models that demonstrate theeffectiveness of non-pegylated rBChE in preventing toxicity and death fromexposure to a broad spectrum of chemical nerve agents," commented Dr. JohnTroyer, Senior Program Director for Protexia(R). "Last week, at the PublicHealth Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholder'sWorkshop, we presented new preliminary findings which suggest that non-pegylated rBChE may also have efficacy as a therapeutic against nerve agentexposure. We're very encouraged by these data, and expect to shortly begin aPhase I study of Protexia(R) (pegylated rBChE) to evaluate its safety inhumans."
"Our advanced development contract is administered through the ChemicalBiological Medical Systems (CBMS) group within the DoD," said Dr. Troyer."CBMS remains at the forefront of the development of novel medicalcountermeasures and we are pleased to work collaboratively with them on ourProtexia(R) development program."
About Protexia(R)
Protexia(R) 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 degradeorganophosphate poisons (e.g. nerve agents) before they cause neurologicaldamage. Protexia(R) is being developed as a pre-exposure prophylactic andpost-exposure therapy for casualties on the battlefield and civilian victimsof nerve agent attacks. Nerve agents belong to a class of compounds known asorganophosphate (OP) agents. OP nerve agents, such as sarin gas, soman, tabunor VX, enter the blood stream via inhalation or absorption through the skin.The nerve agents travel in the circulatory system to the brain and musclescausing the nerves to become over-stimulated which lead to massive convulsionsand death in severe cases.
About Chemical Nerve Agents
Organophosphorous nerve agents, or anti-cholinesterase agents, werediscovered in the 1930s following intensive research into new insecticides.Their discovery represents the beginning of modern chemical warfare. Theseagents cause toxicity by binding to and inhibiting acetylcholinesterase, anenzyme in the body that is essential for nervous system function, leading toincreases in acetylcholine and "cholinergic crisis" that can cause loss ofmuscle control, respiratory failure, paralysis, convulsions, permanent braindamage and eventually death.
These so-called nerve gases, which are actually all liquids at roomtemperature, are lethal far more quickly and in far lower concentrations thanother classical chemical warfare agents such as vesicants, choking agents andblood agents, and are effective both when inhaled and when absorbed throughthe skin. Nerve agents can be classified as either G-agents (sarin, soman,tabun) or V-agents (VX), both of which are exceedingly toxic.
About PharmAthene, Inc.
PharmAthene was formed to meet the critical needs of the United States andits allies by developing and commercializing medical countermeasures againstbiological and chemical weapons. PharmAthene's lead product developmentprograms 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 andtreatment of anthrax infection
-- Protexia(R) -- a novel bioscavenger for the prevention and treatment ofmorbidity and mortality associated with exposure to chemical nerve agents
Statement on Cautionary Factors
Except for the historical information presented herein, matters discussedmay constitute forward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995 that are subject to certain risks anduncertainties that could cause actual results to differ materially from anyfuture results, performance or achievements expressed or implied by suchstatements. Statements that are not historical facts, including statementspreceded 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. PharmAthenedisclaims, however, any intent or obligation to update these forward-lookingstatements. Risks and uncertainties include risk associated with thereliability of the results of the studies relating to human safety andpossible adverse effects resulting from the administration of the Company'sproduct candidates, unexpected funding delays and/or reductions or eliminationof U.S. government funding for one or more of the Company's developmentprograms, the award of government contracts to our competitors, unforeseensafety issues, unexpected determinations that these product candidates provenot to be effective and/or capable of being marketed as products, as well asrisks detailed from time to time in PharmAthene's Forms 10-K and Form 10-Qunder the caption "Risk Factors" and in its other reports filed with the U.S.Securities and Exchange Commission (the "SEC"). In particular, to date wehave not commenced a human clinical trial for Protexia(R), and the studiesdescribed above constitute non-clinical animal studies. Significant additionalnon-clinical animal studies, human clinical trials, and manufacturingdevelopment work remain to be done. At this point there can be no assurancethat this product candidate will be shown to be safe and effective andapproved by regulatory authorities for use in humans. Copies of PharmAthene'spublic disclosure filings are available from its investor relations departmentand our website under the investor relations tab at www.pharmathene.com.-- RypVax(TM) -- a recombinant dual antigen vaccine for plague For more information about PharmAthene, please visit www.PharmAthene.com.
SOURCE PharmAthene, Inc.
