Pyramid Laboratories, Inc. has completed the cGMP manufacturing of Endovasc's Liprostin for the company's proposed Phase IIIa trial for patients suffering from Intermittent Claudication. Endovasc's Liprostin is a liposome-encapsulated form of prostaglandin E-1 (PGE-1), which is known to be a potent vasodilator and platelet inhibitor as well as an anti-inflammatory and anti-thrombotic agent. In February 2006, Endovasc submitted its protocol for the trial of Liprostin for treatment of intermittent claudication, a symptom of Peripheral Arterial Disease, to the FDA. Intermittent claudication causes a cramping sensation in the legs that is present during exercise or walking and occurs as a result of decreased blood and oxygen supply. If left untreated, clots may form and lead to leg ulcers, gangrene and ultimately amputation.
"Pyramid Laboratories is an excellent partner who has successfully manufactured Liprostin for us throughout the earlier phases of our FDA trials. We continue to focus our efforts on the selection of investigators and clinical sites," said Diane Dottavio, Ph.D., Endovasc's chairman and chief executive officer.