The GI Company, Inc., Framingham, Mass., a privately held developer
of gastrointestinal therapeutics, has announced that an abstract
detailing results from a Phase II clinical trial (2006 - ITF - 009) has
been accepted for oral presentation at the 2008 Annual Meeting of the
American Society of Clinical Oncology (ASCO). This Phase II study is
titled, Prophylaxis of recurrent chemotherapy-induced oral mucositis: A
Phase II multicenter, randomized, placebo-controlled trial of
recombinant human intestinal trefoil factor (rhITF).
The presentation is scheduled for Monday, June 2, 2008 from 3:30 PM
- 3:45 PM in room S100a at McCormick Place, Chicago, Illinois. All ASCO
abstracts will be publicly posted on http://www.ASCO.org on Thursday,
May 15 at 9:00 PM (EDT).
The GI Company's lead Phase II clinical candidate, Intestinal
Trefoil Factor (ITF), is an endogenous protein in Phase II development
for the treatment oral mucositis, a common, debilitating complication
resulting from high-dose chemotherapy and / or radiotherapy. The GI
Company has retained Burrill & Company to assist in the selection of
a transaction partner for its clinical programs.
About Intestinal Trefoil Factor
Intestinal Trefoil Factor is an endogenous protein 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. ITF mucositis
therapy is designed to alleviate damage to the soft tissues of the oral
cavity by providing ITF 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 http://www.asco.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 (ITF) 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, as well as clinical programs in
erosive gastritis (NSAID induced), ulcerative colitis and corneal wound
healing. The company is funded through a private equity financing
consortium and has raised over $20M to date.
For more information, visit http://www.thegicompany.com or call
978/745-4200, ext. 105.
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