PINE BROOK, N.J., June 21 /PRNewswire/ -- Elusys Therapeutics Inc., a
privately-held biopharmaceutical company focused on the development of
targeted anti-infective drugs, today announced that the United States Food
and Drug Administration (FDA) has granted Orphan Drug Designation to
Anthim(TM) (ETI-204), the company's anthrax therapeutic.
The FDA's U.S. Orphan Drug Act is intended to assist and encourage
companies to develop safe and effective therapies for the treatment of rare
diseases and disorders. Orphan Drug designation is awarded to compounds
that offer potential therapeutic value in the treatment of rare diseases,
defined as those affecting fewer than 200,000 Americans. This designation
provides companies with financial and regulatory benefits during the course
of orphan drug development, including tax credits related to clinical trial
expenses and a possible exemption from the FDA-user fee.
Elizabeth Posillico, Ph.D., President & CEO of Elusys, commented on the
notice, "Receiving Orphan Drug Designation is another important milestone
for Anthim. Based on its impressive safety and efficacy data, Anthim is a
valuable therapeutic for addition to the U.S. Government's Strategic
National Stockpile. Anthim's low therapeutic dose allows for rapid
intramuscular (IM) delivery, the most effective mode of delivery to
first-responders and civilian personnel in emergency situations."
Anthim Background
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 animal efficacy studies, Anthim demonstrated
complete protection against an anthrax spore challenge with a single
prophylactic dose and has shown significant protection when administered up
to two days after a lethal challenge.
Anthim has been granted Fast Track status (May 2005) and Orphan Drug
Designation by the 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 can be granted
based on efficacy in relevant animal models with an acceptable risk/benefit
profile in humans. In March 2006, Elusys announced the successful
completion of a Phase I human clinical study for Anthim. This study was
designed to determine the safety and tolerability of Anthim in healthy
volunteers, when administered with or without the antibiotic
Ciprofloxacin(R). There were no serious adverse events and the drug was
well tolerated, showing a favorable safety risk/benefit profile, when used
either alone or in combination with Ciprofloxacin(R).
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 formulation 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 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 and Crescendo
Ventures. 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:
Donna LaVoie, ext. 103,
dlavoie@lavoiegroup.com, or Bryan Murphy, ext. 105,
bmurphy@lavoiegroup.com, both of LaVoie Group, for Elusys
Therapeutics Inc., +1-978-745-4200
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