Significant reduction in oral mucositis reported in Phase II study

June 3, 2008
The GI Company says that oral spray rhITF formulation for oral mucositis is safe and well tolerated when dosed to chemotherapy patients.

FRAMINGHAM, Massachusetts, and CHICAGO, Illinois--The GI Company, Inc., a privately held developer of gastrointestinal therapeutics, presented at the American Society of Clinical Oncology 2008 Annual Meeting final results of a Phase II clinical study designed to evaluate the safety and efficacy of the company's lead drug, Intestinal Trefoil Factor.

The GI Company's study abstract (ID: 9514 / 2006 - ITF - 009), first published online at ASCO's Web site May 15, is titled, "Prophylaxis of recurrent chemotherapy-induced oral mucositis: A Phase II multicenter, randomized, placebo-controlled trial of recombinant human Intestinal Trefoil Factor (rhITF)."

At the ASCO 2008 Annual Meeting, Nicholas Barker, Ph.D., president and chief executive officer of The GI Company, presented details of the Phase II clinical study.

Study 2006 - ITF - 009 was designed to evaluate the safety and efficacy of 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.

There were also some statistical differences in the patient diary parameters of placebo patients, most notably increased occurrences of oral discoloration, mouth soreness and overall preference for semi-solid food.

"It is our hope to make a difference in the quality of life of chemotherapy patients," Dr. Barker said. "There are so many people that suffer from this terrible chemotherapy side effect and it is gratifying to have demonstrated striking efficacy in a clinical trial that indicates rhITF oral spray may provide therapeutic relief to this needy patient population."

"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."

2006 - ITF - 009 Study Design
Stage I to IV colorectal cancer patients (N=99) that had experienced symptomatic OM (WHO grade ≥ 2) in the first cycle of chemotherapy were enrolled.

After spontaneous resolution of first cycle mucositis, the patients were randomized at the start of their second cycle of chemotherapy into three groups (N=33/group) and treated with either placebo, rhITF 10 mg/ml (low dose) or rhITF 80 mg/ml (high dose) by oral spray (300µl, 8 times/day) for 14 consecutive days. Patients were assessed on days 1, 3, 5, 7, 10, 12, 14 and 21 ± 2 for WHO and OMAS grades of OM, and treatment-related effects.

Frequency of WHO grade ≥ 2 oral mucositis in the placebo, low-dose rhITF and high-dose rhITF groups was 48.5% (16/33), 9.1% (3/33) and 12.1% (4/33), respectively, reflecting a reduction of 81% and 75% respectively (for either low or high dose) versus placebo, which is highly statistically significant (p<0.001).

Assessment of area under the curve relative to OM/incidence and severity revealed a comparable treatment effect of rhITF versus placebo (WHO scores, p<0.001).

The GI Company's lead Phase II clinical compound, Intestinal Trefoil Factor, is in development for oral mucositis, a common, debilitating complication resulting from high-dose chemotherapy and/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.

The GI Company has retained Burrill & Company to assist in the selection of a transaction partner for its clinical programs.

The GI Company's proprietary, directional, oral-delivery system is designed to deliver rhITF directly to the oral cavity.

The GI Company's rhITF mucositis therapy is being developed to alleviate damage to the soft tissues of the oral cavity by providing rhITF to the cells of the mouth and throat, thereby preventing oral mucositis.

For more information, visit The GI Company.

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