FARMINGDALE, NY, January 11, 2005 – Enzo Biochem, Inc. (NYSE:ENZ) today announced that it has received a $1 million grant from the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) to fund a clinical trial to evaluate the efficacy of the Company’s new immunomodulatory agent EGS21 in the treatment of non-alcoholic steatohepatitis (NASH) or fatty liver disease.
The grant was awarded following the successful completion of numerous preclinical animal model studies and a recently completed Phase I safety study of EGS21 in human subjects, the results of which indicated its safe use. The clinical trial is expected to begin during the next quarter and will be conducted at Hadassah-Hebrew University Hospital in Jerusalem, Israel.
Nonalcoholic fatty liver disease is one of the most common causes of liver disease (pathology) in the United States. NASH is one stage in a disease spectrum that ranges from simple fatty liver or steatosis to steatohepatitis, advanced fibrosis, and end-stage cirrhosis. It is estimated that approximately 8.6 million obese adult Americans may have NASH and that another 30.1 million may have the milder form of fatty liver.
The causes of NASH are not well defined, but the disease usually occurs together with obesity, type II diabetes and hyperlipidemia. The disease is estimated to affect 19 % of the obese population and almost half of morbidly obese individuals; although about 3 % of the lean population may also be affected. The Centers for Disease Control has estimated that the prevalence of obesity in US adults 20 years and older increased about 1% per year over the period 1997 to 2002 and it is reasonable to assume that the increase is continuing.
There is no effective medical therapy currently available for patients with non-alcoholic fatty liver disease.
“The award by the BIRD Foundation is significant recognition of the program we have in progress with regard to EGS21 and our therapeutic platform for immune mediated diseases,” said Dean L. Engelhardt, Ph.D. Executive Vice President of Enzo. “This is an important step forward in our efforts to develop a treatment for NASH and its associated metabolic syndrome, a condition that is estimated to affect close to 9 million obese adult Americans, with many more seriously at risk.
Preclinical laboratory studies were carried out by Enzo scientists and collaborators and suggested that NASH is an immune mediated disease. EGS21 was shown to alleviate the symptoms of the disease and its associated metabolic syndrome in the animal model systems. Administration of the compound led to significant reductions of the hepatic fat content (as assessed by MRI and liver biopsies), body weight, and serum liver enzyme levels as well as marked improvement of the glucose tolerance test and lipid profile. The results of these studies were presented at several international meetings and demonstrated that EGS21 acts on the immune regulatory (NKT) cells and therefore could impact the immune response in the body by modulating its function and adjusting it to a normal state.
BIRD is a 25-year-old foundation funded by Israel and the U.S. Projects are approved by the BIRD Board of Governors, based on confidential proposal reviews by the U.S. National Institute of Standards and Technology and the Office of the Chief Scientist of Israel’s Ministry of Trade and Industry.
About Enzo
Enzo Biochem is engaged in the research, development and manufacture of innovative health care products based on molecular biology and genetic engineering techniques, and in providing diagnostic services to the medical community. The Company’s proprietary labeling and detection products for gene sequencing and genetic analysis are sold to the life sciences market throughout the world. The Company’s therapeutic division is in various stages of clinical evaluation of its proprietary gene medicine for HIV-1 infection and its proprietary immune regulation medicines for hepatitis B and hepatitis C infection and for Crohn’s disease. The Company also holds a patent covering a method and materials for correcting point mutations or small insertions or deletions of genetic material that would allow for editing and correcting certain abnormalities in genes. The Company owns or licenses over 230 patents worldwide. For more information visit our website www.enzo.com.
Except for historical information, the matters discussed in this news release may be considered "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this press release.