Endovasc has submitted its protocol for the phase IIIa clinical trial of the drug to the FDA, and hopes to initiate the trial later this year.
Intermittent claudication, a symptom of peripheral arterial disease, causes a cramping sensation in the legs that is present during exercise or walking and occurs as a result of decreased oxygen supply.
Liprostin is a liposome-encapsulated form of prostaglandin E-1 (PGE-1) known to be a potent vasodilator and platelet inhibitor as well as an anti-inflammatory and anti-thrombotic agent.
“The confirmation of Liprostin’s manufacturing marks the achievement of another important step toward commencing our phase IIIa trials this year. We hope to solidify participating sites for these trials in the coming months,” said Dr Diane Dottavio, Endovasc’s chairman and CEO.