Sucampo Initiates Phase 1 Study Of SPL-017 For Peripheral Arterial Disease

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 01 Jan 2009 - 4:00 PDT

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Sucampo Pharma, Ltd., of Japan, a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), today announced that it has initiated dosing in a first-in-human clinical safety study of a proprietary prostone, SPL-017, as a potential treatment for peripheral arterial disease (PAD).

The randomized, double-blind, placebo-controlled, single-center, single ascending dose study will evaluate the safety and pharmacokinetic profile of SPL-017. A total of 74 healthy adult male subjects will be enrolled in eight dose groups, receiving intravenous doses of SPL-017 ranging from 3mcg to 360 mcg.

Peripheral arterial disease (PAD) is narrowing or blockage of arteries that results in poor blood flow to arms and legs. While many patients with early stages of PAD have mild or no symptoms, as PAD progresses, some experience leg pain while walking or climbing stairs (claudication) and in some cases even at rest. In extreme cases, PAD can lead to critical ischemic lesion and eventually to loss of a leg by amputation.

Gayle Dolecek, P.D., Senior Vice President, Research & Development, Sucampo Pharmaceuticals, Inc., said, "We believe that SPL-017 has potential for treatment of a variety of vascular diseases, including PAD. In preclinical animal studies, intravenously administered SPL-017 improved peripheral circulation without significantly affecting systemic blood pressure. In addition, in other animal studies, SPL-017 had no effect on platelet aggregation and protected endothelial barrier function."

Ryuji Ueno, M.D., Ph.D., Ph.D., Founder, Chairman and Chief Executive Officer, said, "I am pleased that Sucampo's proprietary prostone technology has yielded another prostone compound that may have the ability to target vascular disease. We hope that SPL-017 will offer patients with PAD an additional treatment strategy."

SPL-017 is another pipeline compound that Sucampo Pharmaceuticals has entered into human clinical studies. Sucampo continues to develop cobiprostone (SPI-8811) for treatment of non-steroidal anti-inflammatory drug (NSAID) induced ulcers. Lubiprostone, trade name AMITIZA®, approved in the U.S. as a treatment for Chronic Idiopathic Constipation in adults and Irritable Bowel Syndrome with Constipation in adult women, is currently under development for opioid-induced bowel dysfunction.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., an international biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids 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 currently Advisor, International Business Development. Sucampo Pharmaceuticals markets AMITIZA® (lubiprostone) 24 mcg in the U.S. for Chronic Idiopathic Constipation in adults and AMITIZA 8 mcg in the U.S. to treat Irritable Bowel Syndrome with Constipation in adult women. Sucampo is also developing the drug for opioid-induced bowel dysfunction. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., located in Oxford, UK, and 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® 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 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.