Sucampo Initiates Phase 1 Study of SPL-017 for Peripheral Arterial Disease
News Dec 19, 2008
Sucampo Pharma, Ltd. 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.”