Single, Intramuscular (IM) Dose, Protects up to 75 Percent in Primate Study
PINE BROOK, N.J., April 22 /PRNewswire/ -- Elusys Therapeutics, Inc.
(Elusys), a privately-held biopharmaceutical company developing
antibody-based therapies for the treatment of life-threatening infectious
diseases, today announced pivotal animal efficacy results of Anthim(TM), a
high-affinity humanized and deimmunized monoclonal antibody targeting the
anthrax toxin protective antigen.
Elusys' Anthim is designed as a "just in time" anthrax therapeutic that
can be administered by a single, rapid intramuscular injection and has the
potential to provide quick protection against the lethal effects of anthrax
toxin.
In this study, primates were infected with a highly lethal dose of
aerosolized anthrax spores and observed for 60 days. A single IM dose of
Anthim provided significant protection (75% survival) when administered at
the onset of clinical symptoms of disease (24 hr. post exposure). These
results are consistent with a recent rabbit study that showed significant
survival of animals treated 24 hours after infection when bacteremia was
present.
Elizabeth Posillico, Ph.D., President and Chief Executive Officer of
Elusys, commented on the results, "Anthim continues to demonstrate
life-saving potential when given in a single, low IM dose after clinical
symptoms of infection are present. In earlier animal studies, Anthim
provided 100 percent protection when given prior to an anthrax exposure.
These results have been consistent across studies whether Anthim was used
with or without antibiotics. Our Phase I human safety study demonstrated
Anthim is safe and well-tolerated as a monotherapy and as a combined
therapy with the antibiotic ciprofloxacin."
Dr. Posillico continued, "Death from the effects of anthrax toxin can
occur in a few days if patients are not treated quickly. We are very
excited because the results of our studies show that rapid IM treatment
with Anthim has the potential to provide 'instant protective immunity'
against the anthrax toxin in a bioterrorism emergency. We believe Anthim
represents an extremely important medical countermeasure for the treatment
of anthrax and should be added to the National Stockpile."
Currently antibiotics represent the only option for the treatment of
anthrax infection. Antibiotics may be effective in killing the bacteria,
but can still fail to prevent death from the damaging effects of anthrax
toxins. In addition, current antibiotics may not be effective at all
against antibiotic resistant strains of anthrax.
Anthim Background
Anthim is a high-affinity, humanized and deimmunized monoclonal
antibody that targets the protective antigen of B. anthracis and
neutralizes the lethal effects of anthrax toxins. It is being developed for
prevention and treatment of inhalation anthrax. Anthim has been granted
Fast-Track status 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. Elusys has been awarded $32 million from the National Institutes
of Health and the Department of Defense for development of Anthim, of which
$12 million was awarded in September 2007 from the National Institute of
Allergy and Infectious Disease (NIAID), National Institutes of Health, and
the Biomedical Advanced Research and Development Authority (BARDA),
Department of Health and Human Services for advanced development of Anthim.
In April of 2007, Anthim was selected to R&D Directions' list of "100 Great
Investigational Drugs."
About Elusys
Based in Pine Brook, New Jersey, venture-backed Elusys has two
corporate partnerships with MedImmune and Pfizer for development of its HP
Antibodies targeting select infectious diseases. Current venture investors
include Essex Woodlands Health Ventures LLC, Invesco Private Capital,
Crescendo Ventures, MedImmune Ventures and Pfizer. For more information
please visit http://www.elusys.com.
SOURCE Elusys Therapeutics, Inc.
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Related links:
http://www.elusys.com
CONTACT:
Catherine Cloft of LaVoie Group,
+1-978-745-4200 x107, ccloft@lavoiegroup.com, for Elusys
Therapeutics, Inc.
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