FRAMINGHAM, MA and CHICAGO, IL -- 06/02/08 --
The GI Company, Inc., a
privately held developer of gastrointestinal therapeutics, today presented
final results of a Phase II clinical study designed to evaluate the safety
and efficacy of the company's lead drug, Intestinal Trefoil Factor (rhITF),
at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting.
The GI Company's study abstract (ID: 9514 / 2006 - ITF - 009), first
published online at ASCO's website on 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)."
Today at the ASCO 2008 Annual Meeting, Nicholas Barker, Ph.D., presented
full 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.
Nicholas Barker, Ph.D., President and Chief Executive Officer of The GI
Company, commented on the study, "It is our hope to make a difference in
the quality of life of chemotherapy patients. 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."
Dr. Barker continued, "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 (300
microliters, 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
(rhITF), 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.
About Intestinal Trefoil Factor (ITF)
Intestinal Trefoil Factor (ITF) is 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, also called stomatitis, 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 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 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 market represents a $1B annual market
opportunity in the U.S. alone.
About ASCO
The American Society of Clinical Oncology (ASCO) is the world's leading
professional organization representing physicians who care for people with
cancer. With more than 25,000 members, ASCO is committed to improving
cancer care through scientific meetings, educational programs and
peer-reviewed journals. For ASCO information and resources, visit
www.asco.org/presscenter. Patient-oriented cancer information is available
at www.plwc.org.
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 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. For more information, please visit www.thegicompany.com.
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