NEW YORK (Reuters Health) - A preparation of extracted autologous colon proteins administered orally to patients with Crohn’s disease leads to disease remission in many, according to a presentation at the Digestive Disease Week conference, held in Chicago.
To prepare Alequel(tm), “we take material from biopsy of the mucosal layer of the large bowel,” Dr. Dean Engelhardt of Enzo Biochem, Inc. in New York City, told Reuters Health. “We solubilize it and prepare it with a specific buffer that we’re holding as proprietary and then mail it back to the physician.”
“It’s manufactured so the antigens are held pretty much still intact and it’s presented orally three times/week,” he added.
Researchers at Hadassah Hebrew University Medical Center in Jerusalem conducted a randomized, double-blind study in which 31 patients with moderate to severe Crohn’s disease were randomized to placebo or oral Alequel.
According to the meeting abstract, 58% of those in the Alequel group achieved clinical remission compared with 29% of those on placebo; clinical response rates were 67% and 43%, respectively. Responses to the Inflammatory Bowel Disease Questionnaire showed that 43% of those taking Alequel and 12% of those taking placebo achieved an overall improved quality of life. There were no treatment-related adverse events.
“The majority of the effect took place somewhere between 6 and 9 weeks,” Dr. Engelhardt said. “This suggests that the number of immune cells increase enough at that time to effectively ameliorate the symptoms of Crohn’s disease.”
He pointed out that a specific immune profile -- elevated CD4 and natural killer T cells and decreased CD8 cells and C reactive protein - identified the patients most likely to respond to Alequel treatment.
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