Synergy Pharmaceuticals, Inc. (OTC QB: SGYP), a developer of new drugs
to treat gastrointestinal (GI) disorders and diseases, today announced
that poster P409 presented at the upcoming 2011 annual scientific
meeting of the American College of Gastroenterology highlights the
potential use of guanylate cyclase-C agonists to delay progression of
colitis into colon cancer. Poster P409 was selected as an "ACG
Presidential Award Winning Poster”, a recognition given to the most
highly ranked abstracts selected for poster sessions in each category.
The work reported in poster P409 was a collaborative effort between
Synergy scientists and the scientists from Fox Chase Cancer Center,
Philadelphia, Drs. Margie Clapper, Wen-Chi Chang and Harry Cooper.
It is well known that patients with both ulcerative colitis (UC) and
Crohn’s disease (CD) are at an increased risk of developing colorectal
cancer (CRC). A contributing factor to this increased risk appears to be
persistent inflammation of the colon.
"We believe that the therapeutic application of GC-C agonists to
ameliorate GI inflammation has the potential to delay progression into
colon cancer, providing an innovative approach to the treatment of GI
inflammatory diseases and prevention of colon cancer,” said Dr. Kunwar
Shailubhai, Chief Scientific Officer of Synergy Pharmaceuticals. "Our
continued research efforts are focused on exploring GC-C agonists as
orally safe drugs to treat GI inflammation and also control its
progression to colon cancer.”
These findings represent a significant breakthrough in the clinical care
of patients with inflammatory bowel disease, according to Dr. Margie
Clapper, Co-Leader of the Cancer Prevention and Control Program at Fox
Chase Cancer Center. Intervention with GC-C agonists early in the
disease process is expected to block the formation of colon tumors as
well as circumvent the need for hundreds of biopsies and, in some cases,
major surgery.
The date and time for the presentation are:
Monday October 31, 10:30 am to 4:30 pm
Poster P409: Guanylate Cyclase C Agonists as a New Class of Drug
Candidates to Delay Progression of Colitis to Colonic Tumors in ApcMin/+
Mice.
Kunwar Shailubhai1,2, Wen-Chi Chang3,
Shet Masih2, Harry S. Cooper3,
Margie L. Clapper
1Synergy Pharmaceuticals, Doylestown, PA, 2Institute
of Hepatitis Virus Research, Doylestown, PA, and 3Fox
Chase Cancer Center, Philadelphia, PA, USA.
About Ulcerative Colitis
More than 500,000 Americans are afflicted with ulcerative colitis, a
type of IBD that causes chronic inflammation of the colon. Along with
Crohn's disease, the other major form of IBD, ulcerative colitis is
painful and debilitating, and can lead to other serious and
life-threatening complications such as increased incidence of colon
cancer. There is currently no medical cure for ulcerative colitis. A
considerable medical need exists for the control and treatment of
ulcerative colitis.
About Synergy Pharmaceuticals, Inc.
Synergy is a biopharmaceutical company focused on the development of new
drugs to treat gastrointestinal disorders and diseases. Synergy's lead
proprietary drug candidate plecanatide is a synthetic analog of the
human gastrointestinal hormone uroguanylin, and functions by activating
the guanylate cyclase C receptor on epithelial cells of the GI tract.
The company completed a Phase I study of plecanatide in healthy
volunteers and a Phase IIa clinical trial in CIC patients. In October,
2011, Synergy initiated dosing of patients in a major Phase II/III
clinical trial of plecanatide to treat chronic idiopathic constipation.
Plecanatide is also being developed to treat constipation-predominant
irritable bowel syndrome, with the first trial in IBS-C patients planned
for 2012. Synergy’s second GC-C agonist SP-333 is currently in
pre-clinical development to treat inflammatory bowel diseases. More
information is available at http://www.synergypharma.com.
About Fox Chase Cancer Center
Fox Chase Cancer Center is one of the leading cancer research and
treatment centers in the United States. Founded in 1904 in Philadelphia
as one of the nation’s first cancer hospitals, Fox Chase was also among
the first institutions to be designated a National Cancer Institute
Comprehensive Cancer Center in 1974. Fox Chase researchers have won the
highest awards in their fields, including two Nobel Prizes. Fox Chase
physicians are also routinely recognized in national rankings, and the
Center’s nursing program has received the Magnet status for excellence
three consecutive times. Today, Fox Chase conducts a broad array of
nationally competitive basic, translational, and clinical research, with
special programs in cancer prevention, detection, survivorship, and
community outreach. For more information, visit Fox Chase’s Web site at www.foxchase.org
or call 1-888-FOX CHASE or (1-888-369-2427).
Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimated" and "intend," among
others. These forward-looking statements are based on Synergy's current
expectations and actual results could differ materially. There are a
number of factors that could cause actual events to differ materially
from those indicated by such forward-looking statements. These factors
include, but are not limited to, substantial competition; our ability to
continue as a going concern; our need for additional financing;
uncertainties of patent protection and litigation; uncertainties of
government or third party payer reimbursement; limited sales and
marketing efforts and dependence upon third parties; and risks related
to failure to obtain FDA clearances or approvals and noncompliance with
FDA regulations. As with any pharmaceutical under development, there are
significant risks in the development, regulatory approval and
commercialization of new products. There are no guarantees that future
clinical trials discussed in this press release will be completed or
successful or that any product will receive regulatory approval for any
indication or prove to be commercially successful. Synergy does not
undertake an obligation to update or revise any forward-looking
statement. Investors should read the risk factors set forth in Synergy's
Form 10-K for the year ended December 31, 2010 and periodic reports
filed with the Securities and Exchange Commission.
