Pine Brook, NJ – December 7, 2009 – Elusys Therapeutics, Inc. (Elusys), a privately-held biopharmaceutical company developing antibody-based therapies for the treatment of life-threatening infectious diseases, announced today that recent animal efficacy and human safety data from the Company’s Anthim® anthrax anti-toxin program were presented at the Biomedical Advanced Research and Development Authority (BARDA) Industry Day conference, December 4, 2009.
In a podium presentation entitled “Advanced Development of Anthim® (ETI-204), a Highly-Effective Monoclonal Antibody for Treatment of Inhalational Anthrax: results of recent safety and efficacy studies,” Dr. Leslie Casey, Vice President of Research, presented data from rabbit and primate treatment studies as well as clinical safety studies highlighting the therapeutic potential for Anthim in the treatment of anthrax disease. Using an established non-human primate treatment model, up to 79% of animals treated with a single, intravenous dose of Anthim at the onset of symptoms survived a lethal inhalational challenge with anthrax spores. All animals in this study were bacteremic at time of Anthim treatment.
The Company also reported the results of a previously conducted rabbit treatment study. A single dose of Anthim provided up to 94% survival when administered to rabbits after symptoms of disease were present. The results of these two studies are consistent with previously conducted rabbit and primate studies using Anthim and continue to show the dramatic increase in survival that Anthim can provide.
In a separate dose-escalating human clinical safety study, preliminary results show that Anthim continues to be safe and well-tolerated at doses at or above the anticipated efficacious dose in humans.
Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys, commented, “We are extremely pleased with the continued success of our Anthim program as we move into the final stages of drug development. Anthim consistently provides significant survival benefit in the treatment of anthrax infection and is safe and well-tolerated. Our drug has the potential to deliver considerable therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency.”
This project has been supported with federal funds from BARDA, Department of Health and Human Services (HHS), in conjunction with the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), the Department of Health and Human Services (HHS), under Contract No. HHSN272200700035C.
Anthim has been extensively studied in multiple models of anthrax infection and has consistently prevented death in 70 – 100% of animals treated with a single dose of drug. Anthim shows excellent potential as an effective therapeutic for treatment of people infected or exposed to anthrax spores.
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 granted Fast-Track status and Orphan Drug Designation by the FDA. To date, Elusys has been awarded a total of $34 Million in government funding for advanced development of Anthim. Funding has been received from the NIAID, BARDA, HHS, and the Department of Defense (DoD).
Elusys, a private company based in Pine Brook, New Jersey, is focused on the development of antibody therapeutics for the treatment of life-threatening disease. Current venture investors include Essex Woodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures, MedImmune Ventures and Pfizer. For more information please visit www.elusys.com.
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