A peer-reviewed article published this month in the Journal of Clinical Oncology reported positive results for colorectal cancer patients who used an oral spray to combat the effects of moderate-to-severe Oral Mucositis (OM).

The results were reported by The GI Company, whose lead clinical compound, rhITF (recombinant human Intestinal Trefoil Factor) was given to patients in the double-blind, placebo-controlled study. 

"Results of this Phase II study demonstrate that rhITF oral spray formulation is safe and highly effective in the prophylaxis of chemotherapy-induced OM in colorectal cancer patients," GI Company said in a news release.  "Patients also exhibited high compliance in dosing administration" and reported no concerns pertaining to the taste of the oral spray.

The GI Company has an exclusive license for the rhITF technology platform from Massachusetts General Hospital (Mass Gen).  Dr. Daniel K. Podolsky, co-chairman of the GI Company Board, is Mallinkrodt Professor of Medicine and Chief of Gastroenerology at Mass Gen  and Harvard Medical School.  Dr. Douglas Peterson, first author of the rhITF Journal of Oncology publication is a member of the GI Company's scientific advisory board.


The GI Company said it is looking for investors to help advance its oral spray into clinical trails and through the regulatory approval process.  The company has retained merchant bankers, Burrill & Company, to help it identify "global transaction partners."

Dr. Peterson, the lead author, described the study's results as "highly encouraging."  The company noted that the differences between the rhITF groups and placebo "were highly statistically significant."

Ninety-nine colorectal cancer patients participated in the study.  Patient diaries were used to corroborate the measurement of Oral Mucositis following both the World Health Organization scoring system and the Oral Mucositis Assessment Scale.

Based in Framingham, Massachusetts, The GI Company describes itself as a clinical-stage biotechnology company highly specialized at developing drugs to treat gastrointestinal and related diseases.  The company's lead clinical candidate is rhITF.  To date, The GI Company has raised more than $20 million through a private equity financing consortium.