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ENZO Biochem Develops New Therapeutic Platforms to Treat Immune-Mediated Diseases

BOSTON, MA, October 27, 2003—Enzo Biochem, Inc., (NYSE:ENZ) unveiled the results of the joint scientific effort of Enzo and its collaborators in seven separate presentations at two medical meetings that took place yesterday and today.  In general these presentations outlined two new therapeutic platforms the Company is developing for the treatment of a variety of immune mediated disorders.  The two new platforms are, first, the identification of a new specific small molecule that promotes and directs certain specific immune responses, and, second, a cell therapy platform based on the use of regulatory immune cells. 
With the introduction of these two new platforms, as well as the third platform that Enzo continues working on, namely, immune regulation by oral presentation of antigens, Enzo and its collaborators at the Hebrew University-Hadassah Medical Center in Jerusalem, Israel, further demonstrated the scope and the extent of Enzo’s broad based program in developing new therapeutic products.
 
Enzo believes that the continued exploitation of these three powerful and significant immune regulation platforms will enable the Company to develop and launch products for treatment of a broad range of immune mediated diseases including hepatitis B virus and hepatitis C virus (HCV) associated liver disease, various cancers, Crohn’s disease and other forms of inflammatory bowel diseases, diabetes and graft versus host disease. Enzo is already in clinical trials or in preclinical studies with products or procedures for the treatment of many of these immune disorders. 
 
Six of the presentations were made at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
 
A first presentation involved identification of the molecule, glucosylceramide (GC) that acts on immune regulatory (NKT) cells and therefore can impact the immune response in the body by modulating its function and adjusting it to a normal state. This presentation identified a significant correlation in individuals with Gaucher Disease who are also infected with HCV. These patients showed a significant protection of their livers to HCV-associated liver damage when compared to other HCV-infected people. Since Gaucher Disease is a condition in which GC accumulates in the liver, Enzo scientists conclude that GC accumulation protects the patient against immune mediated attack on the liver.
 
In the same vein, a second talk was presented describing a study with laboratory animals that were induced to undergo acute liver failure mediated by an immune attack.  When these animals were treated with GC, the liver failure was reversed. These presentations together identify GC as an important candidate drug in the treatment of certain immune mediated disorders of the liver.
 
Three presentations were made describing results in which the transfer of immune regulatory (NKT) cells (just transferred or trained ex vivo before transfer) significantly altered three separate immune mediated disorders. Two of these three presentations reported on studies in which significant amelioration of the symptoms of, in the first study, graft versus host disease, and, in the second study, fatty liver and diabetes using animal model systems. In both model systems the infusion of large numbers of the NKT cells, led to an elimination of the symptoms of these conditions. A third model system used a procedure to treat these NKT cells outside of the body to enhance their capacity to manage human cell-mediated hepatocellular carcinoma. When the NKT cells were exposed ex vivo to certain specific cancer-cell antigens, and were administered to mice with a fatal type of human liver cancer, the cancers were largely eliminated.
 
In all of these cell-based procedures the primary cell target was the immune NKT cell. This cell type has a significant role in regulating the functioning of the immune system.
 
In a final presentation at the AASLD meeting, studies using a mouse model system for the management of diabetes and obesity were reported. The induction of immune regulation through the administration of specific antigens manufactured from liver tissue significantly reduced the hepatic fat content of these mice compared with controls.  In addition, glucose intolerance (a characteristic of diabetes) improved significantly in these treated mice when compared with untreated controls.  These results suggest that immune modulation may serve as a therapeutic tool in patients with fatty liver disease or certain types of diabetes. 
 
Simultaneously with these presentations at the AASLD in Boston, a major presentation was made by Prof. Yaron Ilan at a New York Academy of Science conference entitled: “Oral tolerance: Mechanisms and Applications”. In this presentation, Dr. Ilan discussed further scientific elaboration of Enzo’s clinical efforts with special reference to the treatment of various forms of hepatitis, Crohn’s disease, graft versus host disease, and various types of cancer.
 
“What is especially significant is that these studies underscore many of the basic premises underlying our work in immune regulation, but now we also have two additional platforms upon which to build entirely new therapeutic approaches to a number of immune mediated diseases,” commented Dr. Engelhardt, Executive Vice President of Enzo.   “These are less traveled paths that we believe offer further opportunities for Enzo’s proprietary approach to developing new medicines and treatment strategies.”
 
 
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, with approximately 200 patents worldwide, are sold to the life sciences market throughout the world.  The Company's therapeutic division is conducting clinical trials of its proprietary gene medicine for HIV-1 infection and clinical trials of 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.  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.