Israeli biotechnology start-up Atox-Bio has won a $3.1 million research grant from the US Department of Defense.
The financing is a follow-up grant for a research project begun seven years ago. The Department of Defense has already awarded $3.4 million for the project, intended to develop and commercialize treatment for toxic shock caused by "flesh-eating" staphylococci bacteria. Additional development and animal tests have now been approved, prior to US Food and Drug Administration (FDA) approval of clinical trials on humans.
R&D is being conducted in cooperation with US Army medical research institutes and the Department of Defense’s Defense Advanced Research Projects Agency (DARPA).
The research has been led for the past ten years by Professor Raymond Kaempfer and Dr. Gila Arad of The Hebrew University-Hadassah Medical School. The research is designing an "antagonist" - a small molecule that blocks the ability of the bacterial toxins to activate immune T cells. It is these cells that introduce cytokine molecules that bring on the toxic shock phenomenon, such as the "flesh-eating" staphylococci bacteria. These toxins are suitable for bioweapons in warfare or terrorism. The research focuses on halting the "toxicity cascade" before activation of the T cells takes place. It is this strategy that led to the development of the "blocking" molecule - a short peptide.
Kaempfer says Atox-Bio will use the grant to finance some of these activities, including production, toxicity testing and first stage clinical trials. Atox-Bio will retain all rights to the research's results.
Under the agreement with the Department of Defense, the US military and NATO forces will equip combat units with kits that include Atox-Bio's antagonist supplied at market prices, as soon as the treatment is approved. Arad told ''Globes'' an IND application for a new drug with the FDA takes about three years.
Toxic shock, caused by staphylococci and streptococci bacteria, can kill with 24-48 hours, and can the most lethal strains can kill so quickly that diagnosis of the bacterial agent is not possible.
The Department of Defense will finance the project only until the concept is proved in animal tests, but is assisting the company with FDA procedures. Atox-Bio is currently planning to raise $5-10 million to prepare a file with the FDA and to finance approval and production of the blocking molecule it developed. Kaempfer said the company would raise the money from private sources.
Atox-Bio, founded in late 2001 by Kaempfer and Arad, is based in the Hebrew University-Hadassah Medical School, and operates under the aegis of Yissum Research and Development Company of the Hebrew University of Jerusalem.
Published by Israel's Business Arena on 15 April 2002