ANNAPOLIS, Md., June 14, 2012 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) today announced additional development progress of its next generation rPA anthrax vaccine, SparVax™, which is being developed to provide protection against anthrax exposure during a national security emergency. Following on the successful cGMP manufacturing of SparVax™ at full commercial scale, the Company has now completed final analytical testing and release of the final drug product in pre-filled syringes for future clinical evaluation.
Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer commented, "This latest achievement represents another major step forward for our SparVax™ program. We now know that SparVax™ manufactured in the United States meets all of the specifications and potency metrics necessary to begin clinical studies. SparVax™ has previously been evaluated in two separate Phase II clinical trials involving approximately 770 subjects. This latest Phase II trial, which we expect will commence in the second half of this year, will be a dose-ranging and schedule study designed to evaluate the safety and immunogenicity of SparVax™ in approximately 300 healthy subjects."
A key differentiator for PharmAthene's rPA technology platform is the utilization of E. coli. This technology enables a more robust manufacturing process and the capability of annually producing more than 150 million rPA vaccine equivalent doses of bulk drug substance (at a 50 mcg dose) – a substantial improvement in rPA production yield compared to the first generation anthrax vaccine.
PharmAthene's rPA anthrax vaccine program 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.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™ - a second generation recombinant protective antigen (rPA) anthrax vaccine
- Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
- rBChE - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
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