FDANews

ENDOVASC SUBMITS PROTOCOL FOR TRIAL OF LIPROSTIN

Endovasc has submitted to the FDA its protocol for a Phase IIIa clinical trial of Liprostin for the treatment of intermittent claudication, a symptom of peripheral arterial disease.

The Phase IIIa trial is a randomized, Placebo-controlled, double-blinded, pharmacokinetic study of two dose levels of Liprostin or placebo administered once-weekly for six weeks. Patients will be followed during the six weeks of infusions and in addition to these sessions, will also be assessed at eight weeks, ten weeks, and four and six months after their first treatment. At the four-month follow-up visit, patients, including those assigned to Placebo, may be eligible for open-label treatment with Liprostin. The trial will enroll approximately 60 patients located at six to ten sites in the U.S.