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.
Elusys Therapeutics Inc.CONTACT: Bryan Murphy of LaVoie Strategic Communications Group, Inc.,+1-781-596-0200 X-105, bmurphy@lavoiegroup.com, for Elusys TherapeuticsInc.
Web site: http://www.elusys.com/