PINE BROOK, N.J., Oct. 3 /PRNewswire/ -- Elusys Therapeutics, Inc. a privately-held biopharmaceutical company focused on the development of targeted anti-infective therapeutics, today announced that it has received Institutional Review Board (IRB) approval for a Phase 1 human safety study of Anthim(TM), the Company’s anthrax antibody therapeutic. Anthim has been granted “Fast Track” status (May 6, 2005) by the Food and Drug Administration (FDA) and this study will begin in the coming weeks.
The Company also reported that it has initiated manufacturing scale-up to produce Anthim in commercial quantities in the event of US Government purchase for the Strategic National Stockpile.
This Phase 1, randomized, placebo-controlled, double blind, dose- escalation study is designed to determine the safety, tolerability and pharmacokinetics of a single dose of Anthim in healthy volunteers. The principal investigator for this study is Glen Apseloff, M.D., Division of Clinical Pharmacology at The Ohio State University Clinical Pharmacology Unit.
Elizabeth Posillico, President & CEO of Elusys Therapeutics commented on today’s announcement, “Elusys has been working closely with the US Government on Anthim and has successfully developed a potent and effective therapeutic that can be delivered intramuscularly in an emergency situation. We are confident that we have developed a product that will effectively meet the Nation’s needs.”
Dr. Posillico added, “The initiation of this Phase 1 study is an important milestone and positions Anthim one-step closer to potential purchase by the US Government under Project BioShield.”
“We have initiated commercial manufacturing scale-up and can move quickly to make Anthim available for the Strategic National Stockpile, concluded Dr. Posillico.”
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.
Anthim 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 has demonstrated efficacy at lower doses than other drugs in development. A single dose of Anthim is 100 percent effective when administered as a prophylactic (prior to anthrax exposure) and dramatically increases survival rates when given up to 48 hours after exposure. Anthim’s low dose will allow for intramuscular (IM) delivery, the most effective mode of delivery to both military and civilian personnel in emergency situations.
Elusys was recently awarded $4.4M from the National Institute of Allergy and Infectious Diseases (NIAID) and $1M from the Department of Defense for advanced development. To date, the Company has been awarded $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. Elusys is currently raising $15 million in additional venture capital funds from new investors and existing shareholders. Current venture investors include Essex Woodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures, EagleAdvisors, and the Legg Mason Emerald Fund. For more information please visit http://www.elusys.com.
Elusys Therapeutics, Inc.
CONTACT: Bryan Murphy of LaVoie Group, +1-781-596-0200 X-105,bmurphy@lavoiegroup.com, for Elusys Therapeutics, Inc.
