PharmAthene Receives FDA Clearance to Reinitiate Clinical Testing of Valortim(R)
ANNAPOLIS, Md., Dec. 9, 2010 /PRNewswire via COMTEX/ --
PharmAthene, Inc. (NYSE Amex: PIP) announced today that the United States Food and Drug Administration (FDA) has provided formal consent for PharmAthene to reinitiate clinical testing of its anthrax anti-toxin, Valortim(R), after lifting the partial clinical hold placed on the program in late 2009.
"We're very pleased to resume clinical testing of Valortim(R)," remarked Dr. Thomas Fuerst, Senior Vice President and Chief Scientific Officer. "The accumulating data suggest that Valortim(R) may have unique characteristics, which could position it as a leading candidate for future procurement in the nation's biodefense stockpile. A presumed different mechanism of action, relative to other anthrax monoclonal antibodies and encouraging efficacy data in animal studies at low doses, suggest that Valortim(R) may offer important advantages in the treatment of symptomatic anthrax infection."
Dr. Fuerst continued, "We have proposed moving forward with a Phase I intravenous dose-escalation study of Valortim(R), which is expected to commence in the next several weeks. We look forward to resuming clinical testing of this important anthrax anti-toxin candidate, which we hope one day will offer improved protection for our nation's citizens, both at home and on the battlefield."
Valortim(R) is a fully human anti-toxin monoclonal antibody being developed for the prevention and treatment of inhalational anthrax. Animal studies suggest that Valortim(R) has the potential to provide protection against anthrax infection when administered prophylactically (prior to the emergence of symptoms of anthrax infection) and also may increase survival when administered therapeutically (once symptoms become evident).
The Valortim(R) project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health and the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSN272200700033C.
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
Valortim(R) - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
rBCHE (recombinant butyrylcholinesterase) - countermeasures for nerve agent poisoning by organophosphate compounds, including nerve gases and pesticides.
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"; "will"; "project"; "potential"; or similar statements are forward-looking statements. PharmAthene disclaims any intent or obligation to update these forward-looking statements other than as required by law. 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, challenges related to the development, scale-up, technology transfer, and/or process validation of manufacturing processes for our product candidates, unexpected determinations that these product candidates prove not to be effective and/or capable of being marketed as products, challenges related to the implementation of our NYSE Amex compliance plan, 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 Valortim(R) 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 www.PharmAthene.com.
SOURCE PharmAthene, Inc.