Company Readies Itself for Commercial Production
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.
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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