Single Intramuscular Dose of Anthim Is More Effective Than Daily Dosing of
Antibiotics Against a Lethal Anthrax Spore Challenge
WASHINGTON, Feb. 16 /PRNewswire/ -- Today, at the 4th Annual American
Society of Microbiology Biodefense Research Conference in Washington DC,
Elusys Therapeutics presented new efficacy data on its anthrax therapeutic,
Anthim(TM).
The presentation (#69D Posterboard 50) entitled, "Intramuscular
Administration of Anthim, a High-Affinity, Anti-Protective Antigen MAb,
Enhances Post-Exposure Antibiotic Efficacy Against Lethal B. anthracis Spore
Challenge," is taking place today from 1:00 - 2:30 PM in the Columbia Ballroom
at the Hyatt Regency Washington.
Dr. Leslie Casey Ph.D., Executive Director, Preclinical Development &
Immunology of Elusys Therapeutics commented, "A risk in treating anthrax
infection with antibiotics alone is that the disease can develop if therapy is
discontinued, due to germination of dormant anthrax spores. These data
highlights Anthim's impressive efficacy as a stand alone therapy and in
combination with an antibiotic."
This study was designed to determine if the co-administration of Anthim
and the antibiotic levofloxacin after exposure to a lethal, aerosolized
anthrax-spore challenge, results in improved survival over antibiotic
treatment alone. An additional arm of the study evaluated the efficacy of a
single intramuscular dose of Anthim, administered without antibiotics after
the lethal anthrax challenge.
Elizabeth Posillico, Ph.D., President and Chief Executive Officer of
Elusys Therapeutics commented on the data, "Anthim meets a critical unmet need
as it provides a treatment option beyond antibiotic therapy. Today's data
provides additional support for the purchase of Anthim for the Strategic
National Stockpile by the U.S. Government under Project BioShield. We
continue to work closely with the National Institutes of Health and the
Department of Defense to further develop Anthim. Elusys is proud to have
developed a product that will save American lives."
About the Study
In the study, rabbits received a lethal challenge of anthrax spores
followed six to twelve hours later by the intramuscular (IM) administration of
a single dose of Anthim and/or a five day course of levofloxacin. Surviving
animals were observed for 34 days and thirty-three percent of the rabbits
receiving levofloxacin alone survived after completing the course of
treatment. In the Anthim treated groups, 100 percent of the rabbits receiving
levofloxacin in combination with Anthim IM survived and 100 percent of the
rabbits receiving only a single IM dose of Anthim after anthrax infection
survived.
About Anthim(TM)
Anthim is a high-affinity monoclonal antibody that targets the protective
antigen (PA) component of anthrax, blocking the bacteria's ability to form
deadly toxins. 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. Elusys is currently conducting the last stage of a Phase I human
safety study of Anthim. The Company has initiated manufacturing scale-up to
produce Anthim in commercial quantities in preparation for a purchase decision
by the U.S. Government for the Strategic National Stockpile.
The ASM Biodefense Conference brings together top scientists conducting
critical research to defend against the growing threat of bioterrorism and
decision makers who are shaping the future biodefense research agenda. For
more information on the ASM Biodefense Conference please visit
http://www.asmbiodefense.org
About Elusys
Elusys is a privately-held biopharmaceutical company focused on the
development of targeted anti-infective therapeutics. Current venture
investors include Essex Woodlands Health Ventures LLC, Invesco Private
Capital, Crescendo Ventures, Eagle Advisors, and the Legg Mason Emerald Fund.
To date, the Company has been awarded $20M from the U.S. Government for the
development of novel therapeutics to combat bioterror agents. For more
information on Elusys please visit http://www.elusys.com.
SOURCE Elusys Therapeutics, Inc.
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Related links:
http://www.elusys.com
http://www.asmbiodefense.org
CONTACT:
Bryan Murphy of LaVoie Group, +1-781-596-0200
ext. 105, bmurphy@lavoiegroup.com, for Elusys Therapeutics, Inc.
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