Company Comments on Recently Passed Pandemic and All-Hazards Preparedness
Act and BARDA Legislation
PINE BROOK, N.J., Dec. 13 /PRNewswire/ -- Elusys Therapeutics, Inc., a
developer of targeted anti-infective therapeutics, today announced that it
has extended its Cooperative Research and Development Agreement (CRDA) with
the United States Army Medical Research Institute of Infectious Diseases
(USAMRIID). Under the agreement, both parties will continue to perform
collaborative research to develop therapeutics against anthrax and other
unspecified biowarfare agents, using Elusys' HP Antibody(TM) technology.
George Elston, Vice President of Finance & Government Affairs at Elusys
Therapeutics, commented on the agreement, "Elusys' work in biodefense began
in 2000 with the initial USAMRIID collaboration and our anthrax
therapeutic, Anthim(TM), evolved from that early research. Elusys has since
advanced Anthim into the final stages of clinical development and today,
this important countermeasure is well-positioned for stockpiling by the
U.S. Government under Project BioShield."
Mr. Elston continued, "The new CRDA extension will focus on the
application of the Elusys HP Antibody technology as a platform for
developing safe and effective countermeasures against biowarfare agents and
other emerging infections. We look forward to continuing this important
collaboration with USAMRIID."
Elusys has received funding from the Department of Defense and the
National Institutes of Health to accelerate the development of Anthim and
the HP Antibody technology. In total, the Company has received over $20
million from the U.S. Government for these programs.
Mr. Elston added, "We are encouraged that Congress has passed S. 3678,
the Pandemic and All-Hazards Preparedness Act, which establishes the
Biomedical Advanced Research and Development Authority (BARDA) within the
Department of Health and Human Services. This legislation will help
important countermeasures, such as Anthim, complete the expensive advanced
development process necessary for purchase by the U.S. Government."
Anthim(TM) Background
Anthim is a high-affinity monoclonal antibody, targeting the anthrax
toxin Protective Antigen, that has demonstrated significant efficacy
against anthrax infection in lethal animal spore challenge studies.
Further, Anthim has been demonstrated to be safe and well tolerated when
administered with and without antibiotics in a human safety study.
Anthim is being developed for prophylaxis and post-exposure treatment
of inhalation anthrax. Anthim's low effective dose allows for rapid
intramuscular delivery to both military and civilian personnel in emergency
situations. 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.
Heteropolymer (HP) Antibodies
HP Antibodies represent a new approach for the treatment of antibiotic
resistant infections, distinct from traditional antibody therapy. HP
Antibodies utilize immune system mechanisms to clear pathogens and provide
a means to develop novel drug candidates targeted against bacterial, viral
and fungal infections. By targeting a unique immune receptor (CR1), HP
Antibodies enhance a natural clearance mechanism and direct the rapid
removal of pathogens from the circulation through tissue macrophages. An
animation of this unique technology is provided via this link:
http://www.elusys.com/technology_hp_animation.php
About USAMRIID
USAMRIID is the lead laboratory for the Department of Defense's Medical
Biological Defense Research Program and plays a key role in National
defense and in infectious disease research. The Institutes' mission is to
conduct basic and applied research on biological threats resulting in
medical solutions (such as vaccines, drugs and diagnostics) to protect the
warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical
Research and Materiel Command. The information contained in this press
release does not necessarily reflect the position or the policy of the
Government and no official endorsement should be inferred.
About Elusys
Elusys is a privately-held biopharmaceutical company focused on the
development of targeted anti-infective therapeutics using proprietary HP
Antibodies for the treatment of life-threatening infectious disease.
Current investors include Essex Woodlands Health Ventures LLC, Invesco
Private Capital, Crescendo Ventures and MedImmune 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_animation.php
CONTACT:
Bryan P. Murphy of LaVoie Group,
+1-978-745-4200 X 105, bmurphy@lavoiegroup.com
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