Japanese subsidiary of US-based Sucampo Pharmaceuticals 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).
According to the company, 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. In extreme cases, PAD can lead to critical ischemic lesion and eventually to loss of a leg by amputation.
Mr Gayle Dolecek, Senior Vice President, Research & Development, Sucampo Pharmaceuticals, 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."
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.