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Sucampo Pharmaceuticals Initiates Phase 2 Trial of Cobiprostone for the Treatment of Portal Hypertension in Patients With Liver Cirrhosis

Posted on: Monday, 28 July 2008, 09:00 CDT

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), today announced that it has enrolled its first patient in a single-center Phase 2 trial evaluating its clinical stage compound, cobiprostone, for the treatment of portal hypertension in patients with liver cirrhosis. Cirrhosis, a chronic degenerative liver disease characterized by fibrous scar tissue on the lobes, inhibits liver function and restricts normal blood flow. The obstruction in blood flow from cirrhosis is a common cause of portal hypertension.

The Phase 2 double-blinded, randomized, placebo-controlled study will assess cobiprostone's safety and efficacy in treating portal hypertension. The study plans to enroll approximately 30 patients at the University of Texas Southwestern Medical Center in Dallas. The primary efficacy endpoint is the change from baseline in hepatic venous pressure gradient (HVPG) following 28 days of study treatment. Secondary endpoints include acute changes in HVPG following initial dosing with cobiprostone, as well as changes in other markers of liver disease and patient-reported quality of life measures.

"The complications of portal hypertension are serious and can even be fatal," said Dr. Don Rockey, Principal Investigator at UT Southwestern. "We need therapies that target and treat portal hypertension so as to mitigate the more serious consequences of this disease."

Cobiprostone is a functional fatty acid and a member of a class of compounds called prostones. It is a locally acting CIC-2 chloride channel activator that works on ion channels located in the liver and the gastrointestinal tract. In preclinical studies, cobiprostone decreased portal vein pressure in a hepatic cirrhosis model and reduced vascular resistance in the liver in ex vivo model. Based on this trial, the company believes that cobiprostone may represent a new therapeutic agent with novel mechanism of action in this indication.

"Approximately one-third of deaths in patients with cirrhosis are caused by esophageal variceal bleeding due to portal hypertension," said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' chairman and chief executive officer. "We believe that cobiprostone may lessen portal vein pressure and may reduce the likelihood of variceal bleeding."

Cobiprostone is also in clinical development for the treatment of gastrointestinal ulcers in patients treated with prescription non-steroidal anti-inflammatory drug (NSAID) therapy. To date, cobiprostone has been evaluated in two Phase 1 trials in healthy volunteers, and in three Phase 2 proof-of-concept trials.

About Portal Hypertension

Portal hypertension is the elevation of portal vein pressure caused by a narrowing of the blood vessel as a result of liver cirrhosis. The rise in portal vein pressure can lead to the development of large, swollen blood vessels in the esophagus, stomach and rectum which, if ruptured, can result in potentially life-threatening blood loss.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, Md., focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are a class of compounds derived from functional fatty acids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' chairman and chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding chief executive officer and advisor, international business development.

Sucampo Pharmaceuticals markets AMITIZA(R) (lubiprostone) in the U.S and is developing the drug for additional indications with large potential markets. In addition, the company has a robust pipeline of compounds with the potential to target unmet medical conditions affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., headquartered in Oxford, UK, with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan. To learn more about Sucampo Pharmaceuticals and its products, visit www.sucampo.com.

AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals, Inc.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words "project,""believe,""anticipate,""plan,""expect,""estimate,""intend,""should,""would,""could,""will,""may" or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors described in Sucampo Pharmaceuticals' filings with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K for the year ended December 31, 2007 and other periodic reports filed with the SEC. Any forward-looking statements in this press release including, without limitation, statements regarding the potential outcome of the Phase 2 trial evaluating and future efficacy of cobiprostone for the treatment of portal hypertension in patients with liver cirrhosis, represent Sucampo Pharmaceuticals' views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the future, Sucampo Pharmaceuticals specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.

Source: Business Wire

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