The second year of the contract, one of the largest contracts awarded by BARDA for advanced product development, will support the company's efforts to gain FDA licensure, including manufacturing activities, human safety trials, and non-clinical effectiveness studies in animals. Elusys has completed two safety studies in humans with Anthim and numerous studies demonstrating safety and efficacy in animal models. Anthim has been granted Fast-Track status and Orphan Drug Designation by the FDA.
Elusys has also recently received funding to support further development of an intramuscular (IM) formulation of Anthim from the Department of Defense. IM administration will allow rapid administration of anti-toxin treatment to large numbers of people in an emergency setting.
Anthim is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins. It is being developed for prevention and treatment of inhalational anthrax following a biowarfare attack.
Anthim has been extensively tested for efficacy and safety in animals and safety in human volunteers. It shows excellent potential as an effective, life-saving, therapeutic for the treatment of people infected by or exposed to anthrax spores. A single dose of Anthim consistently protects 70% to 100% of anthra
|SOURCE Elusys Therapeutics, Inc.|
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