PharmAthene and Medarex Announce $1 Million Congressional Appropriation for Continued Development of Anthrax Therapeutic Valortim(TM)
Wednesday October 11, 6:00 am ET
Detailed pre-clinical research results recently published in the journal Infection and Immunity
PRINCETON, N.J. and ANNAPOLIS, Md., Oct. 11 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) and PharmAthene, Inc., a privately held biotechnology company, today announced that the FY 2007 Department of Defense (DoD) appropriations law includes $1.0 million payable to PharmAthene to support ongoing development of Valortim(TM), an investigational fully human monoclonal antibody being developed for the prevention and treatment of anthrax infection. Valortim was generated by Medarex's UltiMAb Human Antibody Development System®. This is the second consecutive year in which PharmAthene, a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological terrorism, has received funding for further study of Valortim.
David P. Wright, President and Chief Executive Officer of PharmAthene commented, "Given the anthrax attacks of 2001, in which five people died and others were sickened, there is clearly an urgent unmet medical need for newer, more effective therapies for anthrax."
"Based on the available preclinical and clinical data, we believe that Valortim is ideally suited for the prevention and treatment of anthrax infection and is a strong candidate for procurement in the Strategic National Stockpile under Project BioShield," continued Mr. Wright. "Studies have demonstrated efficacy in animals in both pre- and post-exposure prophylaxis and treatment for anthrax infection, potentially enabling therapeutic intervention after the appearance of disease symptoms, when antibiotic therapy is progressively less effective. In addition, we believe that its mechanism of action is distinct from other monoclonal antibodies in advanced development for anthrax, and appears to utilize a similar mechanism to the natural protective response to anthrax vaccine. Valortim has the potential to provide immediate protection compared to vaccines, which may take months to confer similar protection."
"We believe that Valortim has the potential to become an important part of the government's biodefense initiative. This appropriation will help to continue the development of a potentially important product to fight anthrax infection," said Donald L. Drakeman, President and CEO of Medarex.
Findings of preclinical studies describing the activity of Valortim against anthrax infection were published recently in the October 2006 issue of the journal Infection and Immunity. An article abstract is available on the journal web site at iai.asm.org. These findings show that the three-way interaction between Valortim, anthrax protective antigen and Fc receptors (FcR) on macrophage and dendritic cells appears to result in an efficient and potent neutralization of the toxin complex, and this mechanism has not been previously described in studies of other known anthrax neutralizing antibodies. Importantly, the ability to take advantage of this FcR interaction is also found in the protective serum raised in individuals after vaccination with effective anthrax vaccines. These data suggest that the FcR interaction is a characteristic shared by Valortim and optimal natural immune responses raised by vaccination. The companies believe that the FcR interaction may contribute to Valortim's potency and durability of protection seen in the animal studies.
Valortim has recently completed a Phase I open-label, dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of a single dose of Valortim administered intravenously or intramuscularly in healthy volunteers. Results from this trial will be presented October 15th, 2006 at the 44th Annual Meeting of the Infectious Diseases Society of America in Toronto, Canada. |
