Fast-Tracked Anthrax Therapeutic Safe and Well Tolerated
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
SOURCE Elusys Therapeutics Inc.
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Related links:
http://www.elusys.com
http://www.elusys.com/technology_hp_overview.php
CONTACT:
Bryan Murphy of LaVoie Group, +1-781-596-0200
X-105, bmurphy@lavoiegroup.com, for Elusys Therapeutics Inc.
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