ABOUT US
BIODEFENSE
Elusys has been working with the US Government in collaborative research on biowarfare defense since 1999. The Company has received over $32 Million in government funding from the Department of Defense and the National Institutes of Health to advance Anthim™ for the treatment of anthrax infection and the Heteropolymer (HP) Antibody technology. In 2003, the US Government established a $5.6 Billion reserve fund for the stockpiling of countermeasures against threats of bioterrorism. Importantly, anthrax has been established as a material threat by the Department of Homeland Security prompting the need to stockpile necessary countermeasures.
Anthim - Anthrax Anti-Toxin Therapeutic
Anthim is a monoclonal antibody that is effective in the prevention and treatment of anthrax infection without the use of antibiotics. The key to Anthim’s effectiveness is its ability to neutralize the “protective antigen” toxin protein produced by anthrax bacteria during an infection, inhibiting the formation of deadly toxins.
Anthim has demonstrated significant efficacy in the treatment of anthrax infection and has successfully completed a phase I safety study in humans.
Anthim is the solution to a critical weakness in the armamentarium against this deadly agent. Antibiotic and vaccine options have limited effectiveness against an infection that is producing deadly toxins. Toxin formation can occur within 24 hours after exposure.
An IND was filed on February 24, 2005, and Anthim has received Fast Track and Orphan Drug status at FDA. The first in human safety study was completed in April, 2006, demonstrating a favorable safety profile and the data was presented at the 2006 ICAAC meeting. An Emergency Use Authorization application has been filed with FDA and it is advancing through that process. This program is funded by National Institute of Allergy & Infectious Diseases (NIAID) Challenge Grants AI062546-01 and AI067185-01 for advanced development, including safety and efficacy studies. Elusys has held meetings with the FDA, the Office of Emergency Preparedness and other agencies to provide updates and to solicit guidance for continued development of this important drug.
Anthim well-positioned for purchase by the US Government for the Strategic National Stockpile. A “Request for Procurement” (RFP) for anthrax treatment counter-measures is expected in 2007.
Links
Summary of Anthim – Anthrax Anti-Toxin Therapeutic
Anthim publications
Biomedical Advanced Research and Development Authority (BARDA)