By Kim Coghill
Endovasc Ltd. Inc. said it intends to bypass Phase II trials and move directly into Phase III for Liprostin in critical limb ischemic patients.
Liprostin, a vasodilator and stimulator for new blood vessel growth, will be used to assist in the process of keeping vessels open and receptive to healthy blood flow. The drug is a liposome-encapsulated PGE-1.
David Summers, chairman and CEO of Montgomery, Texas-based Endovasc, said due to existing available data on Liprostin and the lack of a current drug for the amputation indication, the FDA granted the company a waiver on Phase I/II trials. However, he said, in order to collect its own data, Endovasc did conduct Phase I trials.
¿The Holy Grail that we are going after is the reduction or elimination of restenosis from an interventional procedure, including restenosis for a balloon angioplasty or bypass surgery,¿ Summers said.
Pending FDA approval, the company will move forward with a Phase III study of 150 patients in need of amputation. The study is expected to begin in November and conclude the following year with a targeted new drug application in early 2003.
Trial endpoints are limb salvage, mortality or amputation in six months. The protocol is ready for submission, but site selection and investigator enrollment continues.
¿If we can¿t help them, obviously they are going to need amputation,¿ Summers said. ¿But we are going to give them six months and hopefully we can give them a better quality of life.¿
Critical limb ischemia is caused by the occlusion of blood vessels in the lower limbs and extremities, preventing oxygenated blood flow to the affected areas. Eventually gangrene results and the only option to save the patient¿s life is amputation.
Endovasc¿s stock (OTCBB:ENDV) closed Monday at 14 cents per share, up 4.5 cents, or 47 percent.