ORLANDO, FL, May 20, 2003 – Enzo Biochem, Inc. (NYSE:ENZ), today announced highly favorable results of its Phase I clinical trial of a new treatment for Crohn’s disease. The treatment, a complex of autologous colon-specific antigens administered orally, is based on Enzo’s proprietary immune regulation platform. Enzo said that during the course of the clinical trial all 10 subjects in the study showed a clinical response to the treatment, with seven achieving clinical remission.
The results of the Phase I clinical trial were presented today at the annual meeting here of the American Association of Gastroenterology by Yaron Ilan, M.D., the principal investigator. The trial was conducted at the Gastroenterology and Liver Units at the Hebrew University-Hadassah Medical Center, Jerusalem, Israel sponsored by Enzo Therapeutics.
Enzo said it plans to initiate a Phase II random label double-blind study of the treatment within 30 days.
“Crohn’s disease is a highly debilitating widespread ailment for which there is no effective treatment,” said Dean L. Engelhardt, Ph.D., Executive Vice President of Enzo. “The results of this initial clinical study are promising, and if our treatment is validated in further studies it would represent a truly major achievement that would bring relief to many sufferers of the disease, without the side effects found with current therapies.”
Ten subjects with mild to moderate Crohn’s disease were admitted to the trial and were treated with the study drug. The drug was administered orally three times a week for 16 weeks. During the course of the treatment period, all 10 subjects had a clinical response to the treatment and seven achieved clinical remission. Response was measured by a significant decrease in CDAI (Crohn’s Disease Activity Index), a standard measure of the severity of the disease. The Phase I study was an open label trial of six male and four female subjects, ages 19 to 58, who have suffered from Crohn’s Disease for an average of 11 years. The median time of response to the treatment was five weeks. No treatment related adverse events were noted in any of the subjects.
Crohn’s disease is a chronic, serious inflammatory disease of the 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 response by “T” cells that ultimately can cause extensive intestinal damage. The disease usually is characterized by diarrhea, abdominal pain and fever, as well as loss of appetite 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.
Enzo’s proprietary treatment for Crohn’s Disease is a complex of autologous colon-specific antigens administered orally, and is designed to manage the disease by specifically regulating the immune system. Many current methods of treatment are based on the use of general immune suppression approaches which can lead to significant side effects. To date, no treatment-related adverse effects have been reported with Enzo’s treatment.
Immune regulation by oral administration of the autologous complex of antigens appears to be a safe and possibly effective treatment for individuals Crohn’s Disease. This treatment modality may provide a means of antigen specific immune regulation in the bowel for these individuals. Enzo would anticipate utilizing its proprietary Crohn’s disease formula in a manner that would result in the creation of a personal medicine for each patient since the drug is manufactured from antigens removed from each individual subject. This could be the first in a line of personal medicine products.
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.
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