NEWS & EVENTS
PRESS RELEASES 2004
ELUSYS THERAPEUTICS ANTHRAX PRODUCT SELECTED FOR TESTING BY FEDERAL GOVERNMENT
Government Evaluating Promising Drug Candidate for Prevention or Treatment of Anthrax Infection
Pine Brook, NJ – May 5, 2004 – Elusys Therapeutics, Inc. announced today that its anti-anthrax antibody, trade name AnthimTM (ETI-204), was selected by the Centers for Disease Control and Prevention (CDC) for evaluation by the government. Anthim is an affinity-enhanced monoclonal antibody being developed for the prevention and treatment of infection and death caused by anthrax toxin. Anthim is designed to remove the toxin from the bloodstream even after symptoms appear.
CDC will evaluate the Elusys product to obtain data that will be used by CDC and the Department of Health and Human Services (DHHS) to make decisions on a procurement strategy to meet the nation’s biodefense needs for both therapeutic and prophylactic treatments for anthrax.
“Anthim has shown some remarkable protective and therapeutic qualities in our research to date,” said Stephen Sudovar, president and CEO of Elusys. “We are pleased the government is taking a closer look at Anthim. While vaccines and antibiotics can offer some protection for Americans in the event of another anthrax attack, they have major limitations which an anti-toxin can address.”
The current anthrax vaccine requires six injections over 18 months plus yearly boosters to provide full immunity. This is unrealistic in the civilian population. Antibiotics destroy the anthrax bacteria and are usually only effective when given immediately after exposure or upon suspicion of exposure to anthrax. In addition, antibiotics are not effective against the anthrax toxin, which is what causes inflammation, organ failure and death. Anthim would remove the toxin from the bloodstream even after symptoms appear and buy crucial time for later-stage antibiotic treatment.
Striking Data
“Studies with Anthim have clearly demonstrated protection from death at low doses,” said Linda Nardone, PhD, Vice President of Clinical and Regulatory Affairs for Elusys. “Having reviewed the available data on other antibodies, Anthim is the best anti-anthrax antibody under development, in our judgment.”
In March, Elusys presented data at the American Society of Microbiology Biodefense Research and Funding meeting that showed:
· Anthim completely protects two different species of animals when given before exposure to anthrax spores. All of the animals given ETI-204 survived, while none of the animals that received placebo survived past five days.
· Anthim cleared bacteria from the site of infection and kept it out of circulation in the bloodstream. Blood analyses from seven of nine rabbits treated with Anthim had no evidence of bacteria in the lungs, which was the site of infection, and none of the treated rabbits had bacteria in their blood at any time point.
· There was no evidence of Anthim in the bloodstreams of the treated rabbits by day 28, and the rabbits remained free of infection.
· There was no evidence of side effects or safety concerns in any of the subjects receiving Anthim.
In addition, Elusys has new data showing that Anthim protects animals when it is given after they have been exposed to anthrax spores. Data from recent studies demonstrate that therapeutically effective levels of Anthim can be delivered by intramuscular injection, which will allow more rapid deployment than intravenous injection, especially in emergency situations. Elusys will release the post-exposure and intramuscular data in the near future.
The Elusys Anthrax Monoclonal Antibody
Under the agreement, called a Material Transfer Agreement, Elusys has provided Anthim to the CDC. Anthim is an affinity-enhanced antibody produced by DeImmunizationTM technology, which means that its ability to bind to its target pathogen has been strengthened and that elements that might cause an immune response have been removed. Anthim targets and binds to Protective Antigen, which prevents the anthrax toxins from binding to and entering the cells in the body, thereby preventing death. Monoclonal antibodies as a class, which are directed against viruses, bacteria, or toxins, have an outstanding safety profile.
About Elusys
Elusys develops antibody-based therapies using proprietary technologies in Heteropolymer antibody chemistry and complement biology. The Company’s pipeline of products includes treatments for cancer, lupus nephritis, infectious diseases and thrombosis. The Company has successfully advanced three products to the IND and Phase I stage, with additional products in its pipeline. Founded in 1998, Elusys is headquartered in Pine Brook, NJ. Additional information about Elusys can be found at www.elusys.com.