ANNAPOLIS, Md., June 2 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that it has submitted a proposal to the Biomedical Advanced Research and Development Authority (BARDA) in response to a Broad Agency Announcement (BAA-BARDA-09-34) for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats. PharmAthene has requested funding to further develop Valortim(R), a fully human monoclonal antibody, for the prevention and treatment of anthrax infection. To date, the Company has received funding commitments from the U. S. government totaling up to $24 million to advance the development of Valortim(R).
David P. Wright, President and Chief Executive Officer of PharmAthene, commented, "We look forward to BARDA's decision regarding our funding proposal for the advanced development of Valortim(R). We believe that Valortim(R) may have important competitive advantages, including a novel mechanism of action, which, if demonstrated, would make it a strong choice for procurement consideration in the Strategic National Stockpile (SNS). Additional funding will allow us to complete clinical and non-clinical efforts through pivotal safety and efficacy studies, and to perform cGMP and conformance lot manufacturing. If successful, Valortim(R) may be eligible for acquisition into the SNS for potential use under an Emergency Use Authorization (EUA), and for submission of a Biologics License Application (BLA)."
Valortim(R) is a fully human monoclonal antibody generated by Medarex, Inc's UltiMAb(R) technology that is being co-developed by the two companies and is designed to protect against and treat anthrax infection, including inhalational anthrax, the most lethal form of illness in humans caused by the Bacillus anthracis bacterium. The investigational antibody is designed to target a protein component known as the anthrax Protective Antigen (PA) of the lethal and edema toxin complexes produced by the bacterium. Preclinical studies suggest that Valortim(R) has the potential to provide significant protection against anthrax infection when administered prophylactically post-exposure (i.e., prior to the emergence of symptoms of anthrax infection) and to increase survival when administered therapeutically (i.e., once symptoms become evident).
As previously presented, Valortim(R) has been administered intravenously and intramuscularly to healthy human volunteers in a completed Phase 1 study, was well tolerated at doses as high as 20 mg/kg (IV), and was not immunogenic. Pharmacokinetic analysis suggested that doses as low as 1 mg/kg resulted in circulating levels of antibody after a month, with a similar potency for neutralizing anthrax toxin in vitro as was seen with serum obtained from subjects who had been vaccinated with anthrax vaccine.
Anti-toxins such as Valortim(R) are a key element in combating and treating anthrax infection, in addition to vaccines and antibiotics, and are an essential requirement for the Strategic National Stockpile. PharmAthene believes that Valortim(R) is well positioned for procurement consideration in the civilian biomedical stockpile.
According to the Centers for Disease Control and Prevention, anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in hoofed mammals and can also infect humans. Symptoms of disease vary depending on how the disease is contracted, but usually occur within seven days after exposure. The serious forms of human anthrax are inhalation anthrax, cutaneous anthrax, and intestinal anthrax. Initial symptoms of inhalation anthrax infection may resemble a common cold. After several days, the symptoms may progress to severe breathing problems and shock. Inhalation anthrax is often fatal, even if treated by antibiotics. Currently, antibiotics are the only drugs available for therapeutic or prophylactic use for inhalation anthrax, and post-exposure prophylaxis is the only FDA-approved indication for such products. However, antibiotic therapy, while useful, is believed to be associated with a number of limitations, including: (1) lack of activity against the toxins produced by the B. anthracis bacteria, (2) need for long-term dosing to achieve full protection, complicated by side effects and non-compliance (3) lack of efficacy when administered late in the anthrax disease cycle, and (4) lack of effectiveness against multi-drug resistant or genetically engineered strains of anthrax.
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:
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, including without limitation our bid related to SparVax(TM) under the DHHS Request for Proposals for an Anthrax Recombinant Protective Antigen (rPA) Vaccine for the Strategic National Stockpile, the award of government contracts to our competitors, unforeseen safety issues, challenges related to the development, scale-up, 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, 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, there can be no assurance that the Company will be awarded a contract under the solicitation under BAA-BARDA-09-34. .Further, significant additional non-clinical animal studies, human clinical trials, and manufacturing development work remain to be completed for Valortim(R). 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.|
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