Single Intramuscular Dose Of Anthim Is More Effective Than Daily Dosing Of Antibiotics Against A Lethal Anthrax Spore Challenge

Main Category: Bio-terrorism / Terrorism
Also Included In: Clinical Trials / Drug Trials
Article Date: 18 Feb 2006 - 22:00 PDT

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Today, at the 4th Annual American Society of Microbiology Biodefense Research Conference in Washington DC, Elusys Therapeutics presented new efficacy data on its anthrax therapeutic, Anthim(TM).

The presentation (#69D Posterboard 50) entitled, "Intramuscular Administration of Anthim, a High-Affinity, Anti-Protective Antigen MAb, Enhances Post-Exposure Antibiotic Efficacy Against Lethal B. anthracis Spore Challenge," is taking place today from 1:00 - 2:30 PM in the Columbia Ballroom at the Hyatt Regency Washington.

Dr. Leslie Casey Ph.D., Executive Director, Preclinical Development & Immunology of Elusys Therapeutics commented, "A risk in treating anthrax infection with antibiotics alone is that the disease can develop if therapy is discontinued, due to germination of dormant anthrax spores. These data highlights Anthim's impressive efficacy as a stand alone therapy and in combination with an antibiotic."

This study was designed to determine if the co-administration of Anthim and the antibiotic levofloxacin after exposure to a lethal, aerosolized anthrax-spore challenge, results in improved survival over antibiotic treatment alone. An additional arm of the study evaluated the efficacy of a single intramuscular dose of Anthim, administered without antibiotics after the lethal anthrax challenge.

Elizabeth Posillico, Ph.D., President and Chief Executive Officer of Elusys Therapeutics commented on the data, "Anthim meets a critical unmet need as it provides a treatment option beyond antibiotic therapy. Today's data provides additional support for the purchase of Anthim for the Strategic National Stockpile by the U.S. Government under Project BioShield. We continue to work closely with the National Institutes of Health and the Department of Defense to further develop Anthim. Elusys is proud to have developed a product that will save American lives."

About the Study

In the study, rabbits received a lethal challenge of anthrax spores followed six to twelve hours later by the intramuscular (IM) administration of a single dose of Anthim and/or a five day course of levofloxacin. Surviving animals were observed for 34 days and thirty-three percent of the rabbits receiving levofloxacin alone survived after completing the course of treatment. In the Anthim treated groups, 100 percent of the rabbits receiving levofloxacin in combination with Anthim IM survived and 100 percent of the rabbits receiving only a single IM dose of Anthim after anthrax infection survived.

About Anthim(TM)

Anthim is a high-affinity monoclonal antibody that targets the protective antigen (PA) component of anthrax, blocking the bacteria's ability to form deadly toxins. Anthim is being developed under The Food and Drug Administration (FDA) Animal Rule, a regulatory process specifically designed for the development of medical countermeasures to bioterror threats. According to this rule, marketing approval of Anthim can be granted based on efficacy in relevant animal models with only Phase I safety trials required in humans. Elusys is currently conducting the last stage of a Phase I human safety study of Anthim. The Company has initiated manufacturing scale-up to produce Anthim in commercial quantities in preparation for a purchase decision by the U.S. Government for the Strategic National Stockpile.

The ASM Biodefense Conference brings together top scientists conducting critical research to defend against the growing threat of bioterrorism and decision makers who are shaping the future biodefense research agenda.

About Elusys

Elusys is a privately-held biopharmaceutical company focused on the development of targeted anti-infective therapeutics. Current venture investors include Essex Woodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures, Eagle Advisors, and the Legg Mason Emerald Fund.
To date, the Company has been awarded $20M from the U.S. Government for the development of novel therapeutics to combat bioterror agents.

Elusys Therapeutics, Inc.
http://www.elusys.com
http://www.asmbiodefense.org

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