Elusys Therapeutics, Inc. Initiates Third Clinical Safety Study of Anthim, a New Anthrax Treatment; Company Successfully Completes Manufacturing at Commercial Scale
Published: Oct 24, 2011
PINE BROOK, N.J., Oct. 24, 2011 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company focused on the development of antibody therapeutics, announced today that it is initiating a new clinical study to further demonstrate the safety of Anthim (ETI-204), the company's anti-toxin in late-stage development for prevention of disease and death from exposure to inhaled anthrax. The company also announced it has successfully manufactured Anthim at commercial scale. Anthim is an anti-toxin that significantly increases survival in anthrax-infected animals and is a promising candidate for the treatment of anthrax infection in people following a biowarfare attack.
The double blind, placebo-controlled dose-escalating study will include a total of 108 healthy human subjects and is designed to collect additional safety and pharmacokinetic (PK) data on Anthim.
"Our development timeline for Anthim is right on track, and this additional safety and PK data will further prove Anthim's utility as a strong candidate for addition to the Strategic National Stockpile," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "Anthim is demonstrating the potential to deliver significant therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency."
Dr. Posillico will be presenting an update on Anthim's development program at the 10th Annual BIO Investor Forum in San Francisco on October 26.
"We have successfully manufactured Anthim at commercial scale, and look forward to finalizing our commercial production process to ensure the large-scale capacity needed to deliver high quality, consistent quantities of Anthim for the long term," added James Porter, Vice President of Development and Manufacturing at Elusys.
Anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation's top biowarfare threats. Inhaled anthrax is usually fatal, despite treatment with antibiotics, unless the patient is treated soon after exposure.
If all activities in the Anthim development program are completed to the U.S. Food and Drug Administration's (FDA) satisfaction, the federal government could purchase Anthim for the Strategic National Stockpile (SNS) under Project BioShield. Project BioShield was established in 2004 to provide much needed funding to procure important countermeasures to protect the American public in the event of a biowarfare attack.
Elusys has the potential to receive funding totaling up to $143 million for a base plus four option year contract, awarded December 2009, for development of Anthim for treatment of symptomatic patients. The company also received the first U.S. government contract, awarded September 2011, for a base plus three option year contract for $68.9 million, to develop an anthrax anti-toxin for pre- and post-exposure prophylaxis (PEP) use via intramuscular injection (IM).
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 anthrax-infected animals from death.
This project is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201000026C, the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), and the Department of Health and Human Services (HHS), under Contract No. HHSN272200700035C.
About Elusys Therapeutics, Inc.
Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of life-threatening disease. Elusys has been engaged in development of biodefense countermeasures since 2000. The company has established experience in government contract management and to date has received multiple grants and has the potential to receive funding totaling up to $246 million in government funding. Anthim, a highly effective, anthrax anti-toxin, is in late-stage development, and is a strong candidate for future procurement into the Strategic National Stockpile. For more information, please visit www.elusys.com.
SOURCE Elusys Therapeutics