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Enzo Biochem Reports Phase II Data of Alequel for Management of Crohn's Disease; Trial Successfully Meets Clinical End Points.


FARMINGDALE, N.Y. -- Enzo Biochem, Inc. (NYSE NYSE

See: New York Stock Exchange
:ENZ) today announced that the Phase II randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 double-blind study double-blind study,
n experimental technique in clinical research in which neither the researcher nor the patient knows whether the treatment administered is considered inactive (placebo) or active (medicinal).
 of Alequel(TM), the Company's investigational therapeutic modality therapeutic modality,
n an intervention used to heal someone. See model, biomedical and homeopathy.
 for the management of Crohn's disease Crohn's disease: see colitis. , successfully met its clinical endpoints and is moving forward with expanded studies.

The study showed that 67% of the drug-treated subjects had a clinical response compared with 43% of the placebo group. 58% of the drug treated group achieved clinical remission compared with 29% of placebo-treated subjects.

Thirty one subjects were enrolled and 26 completed the study - 12 in the drug-treatment group and 14 in the placebo group. The subjects were evaluated using the Crohn's Disease Activity Index The Crohn's Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. This is of importance in research studies done on medications used to treat Crohn's disease; most major studies on newer medications use the CDAI in  (CDAI CDAI Crohn's Disease Activity Index ), a standard measure of the severity of the disease, with higher scores indicating more severe disease activity. Clinical response is defined as a decrease in CDAI by 100 or more in two consecutive measurements over a 6-week period. Clinical remission is a decrease to a CDAI of 150 or less in two consecutive measurements.

Quality of life was assessed by the Inflammatory Bowel Disease inflammatory bowel disease
n. Abbr. IBD
Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine.
 Questionnaire (IBDQ IBDQ Inflammatory Bowel Disease Questionnaire ), an evaluation of health perception and function, completed by each subject before and at the end of treatment. The study drug group achieved a mean improvement of 43% in quality of life, while the placebo group achieved a mean improvement of 12%, indicating that the treated subjects not only responded to treatment, but that their quality of life improved greatly during the course of the trial.

Detailed data are being submitted for publication.

"These results are encouraging. They show Alequel(TM) to be equivalent to other therapies for Crohn's disease in this subject population, with none of the serious side effects Side effects

Effects of a proposed project on other parts of the firm.
 often found in other treatments," said Dean L. Engelhardt, Ph.D., Executive Vice President of Enzo. "If our results continue in a larger more diverse population, Alequel(TM) could become the treatment of choice for managing Crohn's disease," continued Dr. Engelhardt.

Enzo said the expanded Phase II study, including both dose escalation and a more diverse subject population, is in process.

Currently available modes of treatment are based on non-specific immune suppression strategies and their use can lead to significant drug-related adverse responses. Alequel(TM), a complex of autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
 colon-derived proteins, developed by Enzo is based on the Company's proprietary immune regulation platform and was designed to be a specific and personal mode of treatment for managing Crohn's disease.

Subjects with moderate to severe Crohn's disease, with clinical evidence of active disease were enrolled in the study. Active disease was determined by clinical history, blood tests and/or histology, x-ray, or endoscopy endoscopy

Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the
. The subjects were evaluated using the CDAI and those with a baseline CDAI between 220 and 400 were admitted into the study and were randomized in a double blind format, in which one group received the study drug and a second group was given a placebo.

Crohn's disease is a chronic, serious inflammatory disease of the gastrointestinal tract gastrointestinal tract
n.
The part of the digestive system consisting of the stomach, small intestine, and large intestine.


Gastrointestinal tract 
 that affects at least one half million Americans, according to the Crohn's & Colitis Foundation of America. The disease is triggered by an immune mediated inflammatory response that can cause extensive intestinal damage. The disease usually is characterized by diarrhea, abdominal pain and fever, as well as loss of appetite loss of appetite Medtalk Anorexia, see there  and weight loss. Crohn's disease afflicts people of all ages, but most cases are diagnosed before age 30. Although similar to ulcerative colitis, which affects only the innermost lining of the colon, Crohn's disease involves all layers of the intestine.

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 over 200 patents worldwide, 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. 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.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 29, 2004
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