Funding Supports Clinical Advancement and Manufacturing of New Anthrax Drug
PINE BROOK, N.J., Aug. 3 /PRNewswire/ -- Elusys Therapeutics Inc., a
developer of targeted anti-infective therapeutics, today announced that it has
been awarded an additional $5.4 million from the U.S. Government for the
continued development of Anthim(TM), the Company's antibody therapeutic for
the prevention and treatment of anthrax infection.
This round of the funding includes $4.4 million from the National
Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), and $1 million from the Department of Defense
(DoD). To date, Elusys has been awarded more than $20 million from the U.S.
Government for the development of novel therapeutics to combat bioterror
agents.
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 allows for intramuscular (IM) delivery, the most
effective mode of delivery to both military and civilian personnel in
emergency situations.
"The continued support and funding from the Federal Government sends a
strong message about the therapeutic potential of Anthim," said Dr. Elizabeth
Posillico, President and CEO of Elusys. "This commitment further validates
Elusys' antibody-based science and Heteropolymer technology and reinforces our
position as an innovative developer of targeted anti-infective therapies."
The NIAID grant will support advanced primate efficacy testing and
formulation optimization for Anthim as an intramuscularly delivered drug. The
DoD grant will support commercial manufacturing of Anthim and the production
of bulk antibodies for further testing of the Company's Heteropolymer (HP)
antibody technology.
Elusys is developing Anthim under the Food and Drug Administration (FDA)
Animal Efficacy Rule. This rule is specifically designed for the development
of medical countermeasures to weapons of mass destruction. According to this
rule, for indications in which it would be unethical to conduct efficacy
studies in humans (as is the case with Anthrax infection), marketing approval
may be granted based on the demonstration of efficacy in relevant animal
models and successful completion of Phase I safety trials in humans.
As previously reported, Elusys has conducted and reported on animal
efficacy, pharmacokinetics (PK) and toxicity studies with Anthim. Elusys has
filed and been granted an IND and the FDA has also granted Elusys fast-track
status to develop Anthim. Human safety trials for Anthim are planned to begin
this year.
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.
Elusys' infectious disease product pipeline includes its lead product,
Anthim(TM), a "fast tracked" antibody for anthrax infection. Anthim
represents a near-term revenue opportunity for Elusys as it is a candidate for
procurement by the U.S. Government under Project BioShield and is supported by
studies demonstrating complete protection against a lethal anthrax spore
challenge. Commercial products include ETI-211, targeting antibiotic-
resistant staphylococcus aureus. Additional pipeline products in development
include treatments for Candida and HIV infections.
SOURCE Elusys Therapeutics Inc.
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Related links:
http://www.elusys.com
CONTACT:
Bryan Murphy of LaVoie Strategic
Communications Group, Inc., +1-781-596-0200 X-105,
bmurphy@lavoiegroup.com, for Elusys Therapeutics Inc.
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