ELUSYS AWARDED AN ADDITIONAL $5.4 MILLION FOR ANTHIM

Elusys Therapeutics, a developer of targeted anti-infective therapeutics, announced that it has been awarded an additional $5.4 million from the U.S. Government for the continued development of Anthim, the company's antibody therapeutic for the prevention and treatment of anthrax infection.

This round of funding includes $4.4 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and $1 million from the Defense Department. 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 for both military and civilian personnel in emergency situations.

The NIAID grant will support advanced primate efficacy testing and formulation optimization for Anthim as an intramuscularly delivered drug. The Defense grant will support commercial manufacturing of Anthim and the production of bulk antibodies for further testing of the company's Heteropolymer antibody technology.

Elusys is developing Anthim under the 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 the successful completion of Phase I safety trials in humans.

As previously reported, Elusys has conducted and reported on animal efficacy, pharmacokinetics and toxicity studies with Anthim. Elusys has filed and been granted and investigational new drug, and the FDA has also granted Elusys fast-track status to develop Anthim. Human safety trials for Anthim are planned to begin this year.