NEWS & EVENTS
PRESS RELEASES 2004
ELUSYS THERAPEUTICS RECEIVES BROAD GOVERNMENT FUNDING TO CONTINUE DEVELOPMENT OF ANTI-ANTHRAX DRUG
Funding from National Institutes of Health and Department of Defense Totals More Than $8 Million
Pine Brook, NJ – (October 13, 2004) – Elusys Therapeutics, Inc., announced today that the federal government will provide additional funding for Anthim?, the company’s antibody treatment for exposure to anthrax toxin. Elusys will receive $5 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as well as $3.5 million from the Department of Defense, for the clinical development of Anthim.
"We are pleased with the federal government’s continued confidence in Elusys and in Anthim, and are grateful for this broader support,” said Stephen Sudovar, president and CEO of Elusys. “The federal funds augment the very significant private venture capital Elusys has raised that supports Anthim and the rest of our drug pipeline. "These grants are important in supporting the government's intent to develop and procure new and better therapeutic agents to protect this country from the threat of a biological attack."
Funding from the NIAID/NIH will be used to help support the clinical development of Anthim (also known as ETI-204) and enable the study of the drug’s safety in humans and its efficacy in primates, in accordance with the so-called “animal rule.” In 2000 the Food and Drug Administration adopted a regulation that allows the efficacy of drugs that protect against the effects of biological, nuclear and chemical weapons to be studied in animals, since it would be unethical to do so in humans.
The Department of Defense grant is focused on research into different methods of administration of Anthim that will be faster and more convenient than intravenous injection; measurement of the length of the drug’s protection following exposure to anthrax toxin; and refinements to the production process to expedite the availability of larger quantities of Anthim. Elusys will release the data from this research in the near future.
Anthim Under Consideration for National Stockpile
Anthim is an affinity-enhanced monoclonal antibody (Mab) being developed by Elusys for pre- and post-exposure treatment of inhalation anthrax, the type most likely to be used in a terror attack. Anthim has already demonstrated 100% protection in two animal species when administered prior to exposure to lethal doses of anthrax spores. In addition, Elusys has conducted research showing that Anthim provides significant therapeutic benefits after exposure to anthrax toxin. The company will release the post-exposure data next month.
“Studies with Anthim have delivered strong data demonstrating its protective power at low doses,” said Linda Nardone, VP of clinical and regulatory affairs and director of the company’s biodefense program. “We expect that Anthim will become part of the Strategic National Stockpile to protect military and civilian personnel in the event of an anthrax attack. In fact we are currently putting together a proposal detailing the steps involved in procurement of Anthim in response to the government’s request.”
In the spring, Anthim was selected by the Centers for Disease Control and Prevention (CDC) for evaluation. The CDC and the Department of Health and Human Services will use the data to make decisions on a procurement strategy to meet the nation’s biodefense needs for both therapeutic and prophylactic treatments for anthrax. The CDC’s tests with Anthim validate the company’s data with results that are even more positive.
A Progressive Partnership
“The collaboration between the federal government and Elusys is a progressive model for the public-private sector development of biodefense products,” added Mr. Sudovar. “From the outset, Elusys has worked closely with the government to research and develop a drug to combat exposure to anthrax toxin. This is quite different from the traditional scenario in which the government gives companies money to develop products on their own. This is truly a partnership in which the federal government works with private sector businesses for the best interests of the country.”
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 biodefense, 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.
This anthrax research is supported by the US Army Medical Research and Materiel Command under Grant No. DAMD17-02-1-0701. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the US Army.
In conducting research using animals, the investigator(s) adheres to the laws of the United States and regulations of the Department of Agriculture.
In the conduct of research involving hazardous organisms, the investigator adhered to the CDC-NIH Guide for Biosafety in Microbiological and Biomedical Laboratories.