GI Company’s Phase II mucositis study meets end point

The Phase II study was designed to evaluate the safety and efficacy of Intestinal Trefoil Factor (rhITF) as an oral spray to prevent oral mucositis. rhITF treatment was administered topically to the oral cavity of colorectal cancer patients at high risk of developing oral mucositis (OM) due to chemotherapy. The data show that prophylactic use of rhITF leads to a marked, statistically significant reduction in the occurrence of chemotherapy-induced oral mucositis in this patient population.

This Phase II study met its primary efficacy endpoint as measured by a statistically significant reduction (p= < 0.001) in the proportion of patients developing World Health Organization Scale (WHO Scale) grade > / = 2 oral mucositis (low dose arm 81% / high dose arm 75% decrease) compared to placebo. The study also met its secondary endpoints in mean/median peak oral mucositis scores (WHO Scale and Oral Mucositis Assessment Scale: OMAS). rhITF oral spray was also shown to be safe and well tolerated with no serious adverse events and very few mild-to-moderate adverse events reported.

Nicholas Barker, president and CEO of The GI Company, said: “The GI Company’s lead clinical compound, rhITF, is now well positioned to find a transaction partner to take this important new oral mucositis therapeutic into Phase III clinical development and expedite its commercialization.”