GI Company's Phase II study demonstrates safety of rhITF oral spray formulation

Published today, as an original investigation, in the peer-reviewed Journal of Clinical Oncology, are statistically significant Phase II clinical results of The GI Company's lead clinical compound, rhITF (recombinant human Intestinal Trefoil Factor) oral spray. The article is titled, "A Phase II, Randomized, Double-blind, Placebo-Controlled Study of rhITF Oral Spray for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving 5-Fluorouracil-based Chemotherapy." rhITF oral spray is being developed for the treatment and prevention of oral mucositis (OM). Oral mucositis can be a serious, non-hematologic oral complication of high-dose systemic chemotherapy and radiation-based anti-cancer treatments, and can lead to hospitalization, infection and/or interruptions in the administration of cancer therapy.

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. Patients also exhibited high compliance in dosing administration. The investigators concluded that future clinical studies are warranted in order to develop this important new compound for therapeutic use in OM patients.

The GI Company Inc. has an exclusive license for the rhITF technology platform from Massachusetts General Hospital (MGH). MGH was recently granted U.S. Patent # 7,538,082 with broad claims covering methods for inhibiting ulcerative oral mucositis lesions by administering rhITF. This patent is projected to expire in 2022, although extensions of this term may be envisaged.

Nicholas Barker, Ph.D., President and Chief Executive Officer of The GI Company, commented on the study, "To our knowledge, rhITF is the only topically-administered compound to show such efficacious clinical results in cancer patients. Oral mucositis can be a major cause of clinical complications in these individuals, and can be a dose-limiting toxicity that necessitates treatment modifications, or interruptions, that adversely impact oncologic therapeutic regimens and lessen patient outcomes. There are currently no effective treatments for OM in this type of ambulatory patient population, one that is in dire need of therapeutic relief."

Dr. Barker continued, "The recent grant of U.S. Patent 7,538,082 with broad claims covering the use of rhITF for mucositis provides patent coverage until at least 2022. The company and its licensors have a portfolio of other patents either issued or pending. The GI Company Inc. has developed rhITF into Phase II, and is seeking business partners to advance this important new compound into pivotal clinical trials and regulatory approval. The company has retained Burrill & Company as merchant bankers to facilitate the identification of global transaction partners."

Dr. Barker will give a podium presentation about The GI Company that includes information on this clinical study at the 11th Annual MassBio Investors Forum, on October 6, 2009 at the Sheraton Boston Hotel, Boston, MA USA.

Dr. Douglas Peterson, first author of the rhITF Journal of Clinical Oncology publication and member of The GI Company's scientific advisory board, added, "Management of clinically significant oral mucositis in cancer patients currently represents a significant challenge. Moreover, many of the newer chemotherapeutic agents also have significant oral toxicities. With their introduction into modern clinical oncology practice, the incidence and severity of mucositis may increase. As a consequence, there is a clear, unmet medical need for developing this targeted therapeutic with such an excellent safety profile. The data demonstrate that rhITF can be easily self-administered in the ambulatory setting, and may represent a highly statistically significant intervention for mucositis prophylaxis treatment."

Dr. Peterson continued, "The results of the Phase II study are highly encouraging in the context of these multiple, important issues. In my view, the peer-review publication of this Phase II rhITF study in the Journal of Clinical Oncology is a very important validation. I look forward to the next steps in drug development in order to bring this product to the clinical care setting for the benefit of at-risk cancer patients."