New Data Show PharmAthene's Recombinant Bioscavenger Binds To A Broad Spectrum Of Chemical Nerve Agents
Nerve Agents Including Sarin and Tabun are Believed to be Part of the Syrian Chemical Weapons Inventory
ANNAPOLIS, Md., April 17, 2013 /PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the U.S. Army Medical Research Institute for Chemical Defense has completed initial in vitro testing of the Company's recombinant butyrylcholinesterase (rBChE) bioscavenger demonstrating that it successfully targets and binds to a broad spectrum of nerve agents, including sarin and tabun, which are believed to be part of the Syrian chemical weapons inventory.
"These promising new data demonstrate that PharmAthene's next generation rBChE bioscavenger may be a viable candidate as a prophylactic and therapeutic for nerve agent poisoning," remarked Eric I. Richman, President and Chief Executive Officer. "PharmAthene is proud to be working in collaboration with the Department of Defense (DoD) to develop innovative new medical countermeasures solutions to address significant national security imperatives. If successful, our next generation rBChE bioscavenger could provide an efficient and flexible manufacturing approach and a more cost-effective solution for the U.S. government to address the threat of chemical weapons."
Butyrylcholinesterase (BChE) is a naturally occurring protein found in minute quantities in blood. It functions as a natural bioscavenger to absorb toxins such as organophosphorous compounds (nerve agents) and certain pesticides, before they cause irreversible neurological damage.
Previous non-clinical studies in animals demonstrate that rBChE can provide significant protection against chemical nerve agent poisoning when administered prophylactically (prior to exposure to nerve agent) and also may increase survival when administered therapeutically (following nerve agent exposure).
"In addition to these latest nerve agent binding data, we have recently demonstrated that rBChE produced using the PER.C6® human cell line is readily scalable with greater than 99% purity," commented Dr. John Troyer, Vice President, Chemical Defense Product Development. "Moreover, the PER.C6® manufacturing platform yields up to two thousand-fold more product per liter than human plasma-derived BChE. Pharmacokinetic testing is currently underway and we expect to begin non-clinical efficacy testing in the coming months."
About rBChE and Nerve Agents
PharmAthene is developing rBChE as a pre- and post-exposure therapy for military or civilian victims of nerve agent attacks. Non-clinical studies in animals of PharmAthene's first generation rBChE product candidate have demonstrated that rBChE has the potential to provide significant protection against chemical nerve agent poisoning when administered prophylactically (prior to exposure to nerve agent) and also may increase survival when administered therapeutically (following nerve agent exposure).
Nerve agents belong to a class of compounds known as organophosphorus (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 leads 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 agents. PharmAthene's lead product development programs include:
- SparVax® - next generation recombinant protective antigen (rPA) anthrax vaccine
- Recombinant BChE- novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
- Valortim® - fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, pursuant to a final judgment issued May 31, 2012 from the Delaware Court of Chancery, PharmAthene is entitled to 50% of the net profits (as defined in the Court's final judgment) over 10 years from all sales of SIGA Technologies' Arestvyr™ (formerly called ST-246®), a novel smallpox antiviral agent being developed by SIGA for the treatment and prevention of morbidity and mortality associated with exposure to the causative agent of smallpox, and related products, once SIGA receives the first $40 million in net profits from sales of Arestvyr™. Both parties have appealed aspects of this ruling to the Delaware Supreme Court. A decision from the high court is expected in the second quarter of 2013. 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 Form 10-K under the caption "Risk Factors" and in its other reports filed with the U.S. Securities and Exchange Commission (the "SEC"). In particular, significant additional research work, non-clinical animal studies, human clinical trials, and manufacturing development work remain to be done with respect to rBChE. At this point there can be no assurance that this product candidate will be shown to be safe and effective and approved by regulatory authorities for use in humans. Copies of PharmAthene's public disclosure filings are available from its investor relations department and our website under the investor relations tab at http://www.pharmathene.com.
SOURCE PharmAthene, Inc.
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