PharmAthene Presents New Anthrax Data At The 5th Annual PHEMCE Stakeholders Workshop And BARDA Industry Day
ANNAPOLIS, Md., Jan. 13, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the Company recently presented new data from its anthrax anti-toxin and recombinant Protective Antigen (rPA) anthrax vaccine programs at the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop and the Biomedical Advanced Research and Development Authority (BARDA) Industry Day, held January 11 – 13, 2011 in Washington, DC.
"BARDA continues to move forward to work closely with industry in the development and procurement of new medical countermeasures," commented Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer of PharmAthene. "We are delighted to present new data from our biodefense programs, which demonstrate progress towards our shared goal of enhancing biodefense national security initiatives. As the data illustrate, PharmAthene continues to advance its pipeline and further its leadership position in biodefense."
Valortim® Anthrax Anti-Toxin Findings Reported
In an oral presentation entitled, "Comparison of Functional Activity and Pharmacokinetic Data from Nonclinical Valortim® Efficacy Studies: Implications for the Animal Rule" Dr. James Bourdage, Director of Bioanalytical Assay Development, at PharmAthene presented a biostatistical analysis of pharmacokinetic and toxin neutralization assay results for multiple Valortim ® doses in three separate animal species – the African Green Monkey, New Zealand White Rabbit and Cynomolgus Monkey.In these studies, animals were exposed to anthrax spores and subsequently treated with various doses of Valortim ® upon detection of antigenemia (evidence of bacterial infection in the bloodstream) and/or significant increases in body temperature (in the case of New Zealand White rabbits). Pharmacokinetic (PK) analysis of serum samples was conducted utilizing a capture ELISA assay and a toxin neutralization assay (TNA). Comparisons of the pharmacokinetic and toxin neutralization results for multiple Valortim ® doses across the three separate species indicated that the TNA/PK ratios were relatively consistent within individual animals across various time points ranging from five minutes to five days for doses ranging from 2.5 to 40 mg/kg. While the absolute ratios differed slightly for some animals, the consistency of these ratios across time, regardless of dose, species, or animal outcome, suggests the suitability of these assays in providing reliable data to support the Food and Drug Administration's use of the 'The Animal Rule' to approve new drugs or biological products when human efficacy studies are not ethical or feasible. Dr. Bourdage commented, "Despite the presence of potentially interfering substances in animals with active disease, we're very encouraged that two separate assays evaluating Valortim ® concentration and functional activity demonstrated comparable results. In our opinion, this suggests the utility of these assays in providing data to support use of the Animal Rule for the approval of novel medical countermeasures, and thus represents a potentially important advance in the development of monoclonal antibody-based anthrax anti-toxins." Funding for these studies was provided by the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) under contract HHSN27220070033C and by the Department of Defense under contract WB81XWH-07-2-0036.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV