NEW YORK--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.