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news.The GI Company has reported encouraging results from a Phase II clinical study designed to evaluate the safety and efficacy of the company's lead clinical compound, intestinal trefoil factor.
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Top-line data from this Phase II safety and efficacy study of intestinal trefoil factor (rhITF) administered to colorectal cancer patients at high risk of developing oral mucositis (OM) due to chemotherapy, revealed a statistically significant effect (p= < 0.001) on the prevention of grade 2 oral mucositis compared to placebo. The data also show rhITF oral spray to be safe, well tolerated and effective. The data confirm that prophylactic use of rhITF leads to a marked reduction in the occurrence of chemotherapy-induced oral mucositis in patients at high risk of developing oral lesions. The GI Company's lead Phase II clinical compound, rhITF, is in development for oral mucositis, a common, debilitating complication resulting from high-dose chemotherapy or radiotherapy. The company also has clinical rhITF programs in a variety of conditions such as erosive gastritis (NSAID induced), ulcerative colitis and corneal wound healing.