SOURCE: The GI Company

The GI Company

September 10, 2009 08:01 ET

Statistically Significant Phase II Clinical Results for Prophylactic Use of rhITF in Mucositis Published in Journal of Clinical Oncology

Patent Granted Through 2022 for the Use of rhITF in Mucositis Indication; Presentation to Be Given at the MassBio Investor Forum October 6, 2009

FRAMINGHAM, MA--(Marketwire - September 10, 2009) - 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."

Study Design & Results Summary

Ninety-nine colorectal cancer patients with moderate-to-severe OM, described by the World Health Organization (WHO) scoring system as grade greater than or equal to 2, in the first cycle of chemotherapy were randomized to receive either placebo, rhITF 10mg/mL (low dose) or rhITF 80mg/mL (high dose) by oral spray (300µL, 8 times/day) for 14 consecutive days in the second chemotherapy cycle. Patients were assessed days 1, 3, 5, 7, 10, 12, 14 and 21 +/- 2 for safety and for OM incidence and severity.

Treatment of patients at high risk for developing OM with low or high dose rhITF significantly reduced incidence (~80%) (low dose rhITF: p < 0.001; high dose rhITF: p = 0.002). Frequency of WHO grade greater than or equal to 2 OM in the placebo, low dose rhITF and high dose rhITF groups was 48.5%, 9.1% and 12.1% respectively.

In addition to the WHO mucositis scoring system, the Oral Mucositis Assessment Scale (OMAS) was run in parallel. Data on OM severity by OMAS corroborated data obtained with the WHO OM Scale. rhITF treatment at both doses decreased the severity of OMAS score between study day 7 through day 14. The area-under-the-curve for mean (SD) peak OMAS scores of the placebo were 3.0 (3.9), compared to low-dose rhITF, and high-dose rhITF groups 0.9 (1.9), and 0.8 (2.2), respectively. Thus the differences between the rhITF groups and placebo were highly statistically significant (p < 0.001).

Only a minority of patients (6.1%) reported treatment-emergent adverse events (TEAE), all of which were mild-moderate in intensity and resolved spontaneously without sequelae. Incidence of TEAE was not significantly different among treatment groups.

Patient diary data were captured during the study. The patients reported no concerns regarding the use of the oral spray (e.g. adverse taste, etc.), overall compliance in the study was 97%. Placebo patients reported a statistically higher preference for semisolid food rather than solid food, increased mouth discoloration, and increased soreness in the mouth and throat. Therefore the patient diary data also corroborates with the WHO, and OMAS mucositis scoring data.

About Intestinal Trefoil Factor (ITF)

Intestinal Trefoil Factor (ITF) is naturally found primarily on mucosal surfaces throughout the gastrointestinal tract, including the mouth, esophagus and intestines, as well as in other tissues such as the eye and lungs. The protein is known to promote mucosal restitution and repair and is therefore being developed as a therapeutic. rhITF mucositis therapy is designed to alleviate damage to the soft tissues of the oral cavity by providing rhITF to the cells of the mouth and throat using a proprietary buccal (oral) delivery system. This therapeutic target is backed by proven biology and compelling efficacy data on ITF in numerous in vivo models of mucosal damage.

About Oral Mucositis

Oral mucositis is a common, serious complication resulting from high-dose chemotherapy and / or radiotherapy. These cytotoxic therapies are used to kill cancer cells, but they also indiscriminately kill other fast-growing normal cells such as those lining the inside of the mouth and throat. Oral mucositis is an inflammation of the mucosa of the mouth which ranges from redness to severe ulcerations on the inner cheek, tongue and lips. These debilitating oral sores further diminish quality of life by preventing patients from eating, drinking, or talking for weeks at a time. These conditions can reappear after every course of treatment. In addition to extremely painful open oral sores, patients with oral mucositis typically have diminished immunity resulting from chemotherapy and / or radiotherapy and are prone to serious life-threatening opportunistic infections. Currently, there is no effective treatment approved by the Food and Drug Administration in multi-cycle chemotherapy or head and neck radiation patients in an ambulatory patient population to prevent oral mucositis or shorten its duration. This condition can affect as many as 80 percent of bone marrow / blood stem cell transplant patients and 40 percent of chemotherapy / radiotherapy patients. This represents a $1B annual market opportunity in the U.S. alone.

About The GI Company, Inc.

The GI Company is a clinical-stage biotechnology company highly specialized at developing drugs to treat gastrointestinal and related diseases. The company's lead clinical candidate is Intestinal Trefoil Factor (rhITF), which is being developed for the treatment of oral mucositis. The GI Company also has clinical rhITF programs in a variety of conditions such as erosive gastritis (NSAID induced), ulcerative colitis and corneal wound healing, as well as pre-clinical development projects in Enteritis/Proctitis, Inflammatory Bowel Disease, Erosive Gastroesophageal Reflux Disease, Peptic Ulcer Disease and gastrointestinal motility disorders. The company is funded through a private equity financing consortium and has raised over $20M to date. The GI Company has retained Burrill & Company to assist in the selection of a transaction partner for its clinical programs. For more information, please visit www.thegicompany.com.