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Enzo Biochem Individualized Oral Immune Regulation Therapy May Be Effective Approach to Treating Crohn's Disease.


Investigators Present Interim Results of Two Clinical Trials at Digestive Disease Week 2007

WASHINGTON -- Alequel[TM], an individualized oral immune regulation preparation, may be an effective treatment for moderate-to-severe Crohn's disease. Interim data from two ongoing double-blind, placebo controlled Phase II studies suggest that this investigational approach induced good clinical remissions and improved patients' quality of life compared to placebo. Medical researchers from Hebrew University-Hadassah Medical Center, Jerusalem, Israel, will today present clinical trial results at Digestive Disease Week 2007, the largest international gathering of academic researchers and practicing physicians in gastrointestinal (GI) specialties, held this year in Washington, DC. The trials were sponsored by Enzo Therapeutics, Inc., a wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
 of Enzo Biochem, Inc. (NYSE NYSE

See: New York Stock Exchange
:ENZ).

"Given our current understanding of Crohn's disease as an inappropriate autoimmune response in the GI tract, we are developing Alequel as an individualized oral treatment that harnesses the patient's own immune system to alleviate symptoms," said Gary C. Cupit, PharmD, President of Enzo Therapeutics. "Many Crohn's patients are frustrated with current treatment options; Alequel is designed to reduce patients' dependence on systemic immunosuppressant drugs. The interim Phase II results encourage us to advance beyond these two studies presented this week at DDW DDW Digestive Disease Week
DDW Diseases of the Developing World
DDW Dimensional Data Warehouse
DDW Digital Data Warfare
DDW Darkness Does Wonders (bar slang)
DDW Data Driven Workflow
. Thus, we are planning to expand into more advanced studies in the United States."

About the Clinical Studies

These two double-blind, placebo-controlled studies 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.
 49 subjects with moderate-to-severe Crohn's disease as measured by 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 ). Alequel[TM] therapy consists of oral administration of an autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
 protein-containing extract, individually prepared from mucosal tissue colon biopsies of the subject obtained through colonoscopy (a common procedure for Crohn's patients). In one trial, subjects received a regimen of 3 weekly doses for 15 weeks of either active treatment or placebo; in the other trial, all subjects received placebo for 3 weeks and then 12 weeks of either active treatment or placebo. Forty subjects were evaluated for an additional 6 weeks after the treatment period.

Outcome measures included clinical remission and response measured by CDAI score, quality of life measured using 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 ), and investigation of a number of potential surrogate biomarkers. Rates of remission and response nearly doubled for evaluable subjects treated with Alequel[TM] compared to placebo, although, due to the size of the studies, the differences were not yet statistically significant. Enzo is currently enrolling additional patients in the trials. Mean percent change in IBDQ quality-of-life score was 3 times greater for patients treated with Alequel[TM] compared to placebo. Treatment was well tolerated, with no treatment-related adverse events reported.

About Crohn's disease (CD)

CD is an idiopathic, immune-mediated disorder currently believed to result from a cascade of processes initiated by unidentified antigens. This inflammatory disease of the GI tract affects approximately 500,000 people in the United States and at least that many in the rest of the world. The disease is characterized by flare-ups of symptoms such as diarrhea, abdominal pain, rectal bleeding and loss of appetite loss of appetite Medtalk Anorexia, see there , alternating with periods of remission. Systemic complications of chronic disease include weight loss, anemia and increased risk of bowel cancer.

About Enzo

In addition to Alequel, Enzo Therapeutics is developing therapies for HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome  and non alcoholic steatohepatitis (NASH Nash   , Ogden 1902-1971.

American writer known for his droll epigrammatic verse, much of which appeared in the New Yorker.

Noun 1. Nash - United States writer noted for his droll epigrams (1902-1971)
Ogden Nash
) and uveitis uveitis

Inflammation of the uvea, the middle coat of the eyeball. Anterior uveitis, involving the iris or ciliary body (containing the muscle that adjusts the lens) or both, can lead to glaucoma and blindness.
, as well as conducting pre-clinical research on candidate therapies for osteoporosis and fractures, among other applications. Enzo Biochem is engaged in the research, development and manufacture of innovative health care products based on molecular biology and genetic engineering techniques, as well as 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. Enzo Biochem owns or licenses over 200 patents worldwide.

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 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 22, 2007
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