Collgard Biopharmaceuticals Announces New Pre-Clinical Study Results Indicating That Tempostatin™ Reverses Existing Liver Fibrosis These pre-clinical results are the "strongest ever observed with potentially anti-fibrotic drugs," reports study investigator Professor Detlef Schuppan November 19, 2002, Boston, MA - Collgard Biopharmaceuticals (www.collgard.com), the tissue therapeutics company, announced today that two new pre-clinical studies show that Tempostatin™ (Halofuginone hydrobromide) can reverse existing liver fibrosis in animal models that closely resemble human disease. The study results were recently presented at the 53rd Annual Meeting of the American Association for the Study of Liver Diseases in Boston on November 3, 2002 by Professor Detlef Schuppan, Vice Director of the Department of Medicine I in the University of Erlangen-Neurnberg, Germany and Dr. Mark Pines of the Volcani Center research institute in Rehovot, Israel. Previous studies have shown that Tempostatin™, Collgard's lead drug candidate, has the capacity to suppress tissue fibrosis (scarring) in response to injury, suggesting that it could potentially arrest the development of cirrhosis in patients with chronic liver disease such as Hepatitis C. The new pre-clinical study results announced today confirm that Tempostatin™ not only has the ability to protect liver tissue from fibrosis during the immediate period of tissue injury but also demonstrates a dramatic capability in reversing existing fibrosis. The fibrolytic finding makes Tempostatin™ the first agent to reverse fibrosis in an already fibrotic liver, restoring the ability of the tissue to regenerate, and challenging the current clinical belief that liver fibrosis is an irreversible condition. The newly reported pre-clinical studies suggest that Tempostatin™ has both antifibrogenic and novel fibrolytic activity, working to prevent the formation of fibrosis as well as break down the distorting extra-cellular matrix by inducing the enzymes MMP 3 and MMP 13. The MMP molecules are highly specialized molecular scalpels that cut and remove the abnormal matrix proteins responsible for maintaining fibrosis. Thus, Tempostatin™ combines the powerful tissue regenerative effects of suppressing Collagen type I synthesis and inducing MMP 3 and MMP 13 working at a submicromolar concentration. "The new findings are of great interest. It appears that once the abnormal matrix proteins have been removed, the tissue regenerative process can then proceed without interference and restore functional tissue. The current study provides a powerful example of how tissue therapeutics may offer great promise for the prevention and reversal of one of the most challenging and complex clinical conditions in medicine today," said Collgard CEO Dr. Bruce Bach, M.D. Ph.D. Chronic liver disease resulting in liver fibrosis is a global health problem affecting more than 800,000 people in the U.S., Europe and Japan. Liver fibrosis and cirrhosis are two of the major causes of liver failure. At present, the only cure for fibrosis is transplantation and the supply of organs is extremely limited. Because fibrotic liver disease may not be detectable until an advanced stage, the possibility of reversing fibrosis represents a critical unmet need for patients with chronic liver disease. "The unique contribution of Tempostatin™ in restoring normal tissue structure after injury is further extended by the promising data in these pre-clinical studies. It provides further evidence that slowing, rather than accelerating the cellular response to injury may provide a significant clinical advance for those patients suffering from fibrotic diseases," Dr. Bach added. About Collgard Biopharmaceuticals Founded in 1996, Collgard Biopharmaceuticals is a clinical stage tissue therapeutics company, led by a global team of medical and drug development experts in Boston, Atlanta and Tel Aviv. The company is currently engaged in Phase II human clinical studies evaluating Tempostatin™ for the prevention and treatment of organ failure, restenosis, and specific cancers. Scientific and clinical collaborators include the U. S. National Cancer Institute (NCI), and the European Organization for Research and Treatment of Cancer (EORTC). About Tempostatin™ Tempostatin™ is a fully synthetic small molecule, identified by Collgard as a "master switch" in the body's tissue repair process. Tempostatin™ works by influencing both the activation of repair cells and the production and clearance of the extra-cellular matrix protein. Back