Elusys' Anthrax Anti-Toxin, Anthim(TM), Enters Second Phase I Clinical Study

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 21 Apr 2009 - 2:00 PDT

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Elusys Therapeutics, Inc. (Elusys), a privately-held biopharmaceutical company developing antibody-based therapies for the treatment of life-threatening infectious diseases, announced the initiation of a second Phase I human safety trial of Anthim(TM), a high-affinity humanized and deimmunized monoclonal antibody targeting the anthrax toxin protective antigen.

The Phase I dose-escalation trial is planned to enroll 45 healthy volunteers and is designed to expand the human safety database. Elizabeth Posillico, Ph.D., President and Chief Executive Officer of Elusys, commented, "We are extremely pleased with the success of our development program for Anthim. Our drug consistently demonstrates remarkable efficacy in treating anthrax infection in animal models and is a strong candidate for addition to the Strategic National Stockpile."

The Company also reported the results of a previously conducted animal efficacy study. A single dose of Anthim provided a significant survival benefit (up to 94 percent survival in treated rabbits vs. 0 percent in controls) when administered to symptomatic rabbits. These results are consistent with several previous rabbit and primate studies that Elusys has conducted and show the dramatic protective effect of Anthim. Dr. Leslie Casey, Vice President of Research, commented, "Anthim has shown significant life-saving potential even when given in a single dose to symptomatic animals many hours after anthrax exposure. In earlier animal studies, Anthim provided 100 percent protection when given within 12 hours of an anthrax exposure. These results have been consistent across studies whether Anthim was used with or without antibiotics. Our first Phase I human safety study demonstrated that Anthim is safe and well-tolerated as a monotherapy and as a combined therapy with the antibiotic ciprofloxacin. This second study will continue to expand our safety database and provide additional pharmacokinetic data."

Dr. Posillico added, "Death from the effects of anthrax toxin can occur in a few days if patients are not treated quickly. We are very excited about Anthim because the results of all of our studies show that treatment with Anthim has the potential to provide significant therapeutic benefit for people infected with anthrax in a bioterrorism emergency." Currently antibiotics represent the only therapeutic option for anthrax infection. Antibiotics target the bacteria, but can still fail to prevent death from the damaging effects of anthrax toxins. In addition, antibiotic resistant strains of anthrax could be used in a bioterror attack, making the medical need for anti-toxin therapy even more acute.

Anthim Background

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 inhalation anthrax. Anthim has been granted Fast-Track status and Orphan Drug Designation by the FDA. The National Institutes of Health and the Department of Defense have awarded Elusys a total of $34 million for the development of Anthim, of which $12 million was awarded in September 2007 under contract #HHSN272200700035 from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services. In April of 2007, Anthim was selected to R&D Directions' list of "100 Great Investigational Drugs."

About Elusys

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.

Source: Elusys Therapeutics, Inc

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