PINE BROOK, N.J., March 29 /PRNewswire/ -- Elusys Therapeutics Inc., a privately-held biopharmaceutical company focused on the development of targeted anti-infective therapeutics, today announced the successful completion of a human clinical study for Anthim(TM), the Company’s fast-tracked anthrax antibody therapeutic. The Phase I study was designed to determine the safety and tolerability of Anthim(TM) in healthy volunteers, when administered with or without the antibiotic Ciprofloxacin(R).
The Principal Investigator for this study, Glen Apseloff, M.D., Division of Clinical Pharmacology at The Ohio State University Clinical Pharmacology Unit commented, “The Anthim Phase 1 study, AH-101, has concluded and all subjects have completed the 42 day study. There were no serious adverse events and the drug was well tolerated, showing a favorable safety risk-profile, when used either alone or in combination with Ciprofloxacin.”
“The successful completion of this human clinical study is an important milestone for Anthim,” commented Elizabeth Posillico, Ph.D., President & CEO of Elusys Therapeutics. “This impressive safety data, combined with its published efficacy data, makes Anthim a valuable anthrax countermeasure for the U.S. Government’s Strategic National Stockpile under Project BioShield.”
Dr. Posillico added, “Based on Anthim’s continued record of impressive clinical results, Elusys has initiated manufacturing scale-up to produce this drug in commercial quantities in preparation for possible U.S. Government procurement Project under BioShield.”
Anthim Background
Anthim(TM) has been granted fast track status by The Food and Drug Administration (FDA) and is being developed under the 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(TM) can be granted based on efficacy in relevant animal models with an acceptable safety risk profile in humans.
Anthim(TM) is a high-affinity monoclonal antibody that targets the protective antigen component of anthrax, blocking the bacteria’s ability to form deadly toxins. In preclinical studies, Anthim(TM) has demonstrated efficacy at lower doses than other drugs in development. A single dose of Anthim(TM) is 100 percent effective in rabbits when administered as a prophylactic (prior to anthrax exposure) and dramatically increases survival rates when given up to 48 hours after exposure. Its low dose allows for rapid intramuscular (IM) delivery, the most effective mode of delivery to both military and civilian personnel in emergency situations.
In 2005, Elusys was awarded over $5 Million from the National Institute of Allergy and Infectious Diseases (NIAID) and the Department of Defense (DoD) for advanced development. To date, the Company has been awarded over $20M from the U.S. Government for the development of novel therapeutics to combat bioterror agents.
About Elusys
Elusys is a privately-held biopharmaceutical company focused on the development of targeted anti-infective therapeutics using its proprietary Heteropolymer Antibodies (HP) for the treatment of infectious disease. Visit http://www.elusys.com/technology_hp_overview.php for more information on the Company’s HP technology.
Current venture investors include Essex Woodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures and the Legg Mason Emerald Fund. For more information please visit http://www.elusys.com.
Contact: Bryan Murphy LaVoie Group 781-596-0200 X-105 bmurphy@lavoiegroup.com
Elusys Therapeutics Inc.
CONTACT: Bryan Murphy of LaVoie Group, +1-781-596-0200 X-105,bmurphy@lavoiegroup.com, for Elusys Therapeutics Inc.
