A preparation of proteins extracted from a person’s own colon cells and administered orally leads to disease remission in many patients with Crohn’s Disease, according to a presentation at the Digestive Disease Week conference, held in Chicago.

To produce the preparation, called Alequel, “we take material from biopsy of the mucosal layer of the large bowel,” said Dr. Dean Engelhardt of Enzo Biochem, Inc. in New York City. “We solubilize it and prepare it with a specific buffer that we’re holding as proprietary and then mail it back to the physician.”
The patient then takes the preparation orally three times per week, he added.

Researchers at Hadassah Hebrew University Medical Center in Jerusalem conducted a clinical trial in which 31 patients with moderate to severe Crohn’s disease were randomly assigned to take oral Alequel or a sham “placebo” preparation.

According to the meeting report, 58 percent of those in the Alequel group achieved clinical remission compared with 29 percent of those on placebo.

Responses to the Inflammatory Bowel Disease Questionnaire showed that 43 percent of those taking Alequel and 12 percent of those taking placebo had 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,” Engelhardt said. “This suggests that the number of immune cells increase enough at that time to effectively ameliorate the symptoms of Crohn’s Disease.”