ANNAPOLIS, Md., April 13, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) announced today that it has completed dosing in a U.S. Phase I clinical trial of its fully human anti-toxin monoclonal antibody, Valortim®, being developed for the prevention and treatment of inhalational anthrax.
The randomized, placebo-controlled, double-blind Phase I clinical trial was designed to evaluate single escalating doses of 1, 5, or 10 mg/kg of Valortim® (or placebo) administered intravenously over a 120 minute infusion period. A total of 28 participants, all healthy male and female volunteers between the ages of 18 and 60 years, were enrolled in the study.
"We have completed dosing of all 28 subjects and are pleased to report that no infusion-related adverse reactions have been observed in the current Phase I trial. We anticipate that safety follow-up will be completed in the third quarter of 2011 with final unblinded results available later in the year," remarked Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer.
"This represents an important step in the development of Valortim®, which is being developed to meet the criteria for stockpiling in the U.S. Strategic National Stockpile," continued Dr. Fuerst. "In preclinical animal studies Valortim® has been shown to protect both rabbits and monkeys against the lethal effects of anthrax infection when administered at the time of exposure, at doses as low as 1.0 mg/kg. When administered to rabbits after the development of symptoms, Valortim® also improved survival as late as 48 hours post-exposure as compared to control animals. We look forward to completing the Phase I clinical trial, which will provide important information about the IV dosing schedule for Valortim® in humans."The Valortim® project has been conducted with support from the National Institute of Allergy and Infectious Diseases, National Institutes of Health and the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSN272200700033C, and is being co-developed with Bristol-Myers Squibb.