Endovasc submits protocol to FDA for phase 3 trial of Liprostin for intermittent claudication

By Lisa Kerner

Erie, Pa., March 6 - Endovasc, Inc. said it has submitted its protocol to the Food and Drug Administration for a phase 3a clinical trial of Liprostin for the treatment of intermittent claudication.

A symptom of peripheral arterial disease, intermittent claudication occurs when arteries supplying blood to the legs become clogged with fatty deposits, resulting in aches or cramps in the calf, buttock or thigh muscles. The symptoms occur when patients walk or exercise and stop when patients rest.

The phase 3a trial is a randomized, placebo-controlled, double-blinded, pharmacokinetic study of two dose levels of Liprostin or a placebo administered once-weekly for six weeks, according to a company news release.

Endovasc said the trial will enroll about 60 patients at six to 10 U.S. sites.

Patients will be followed during six weeks of infusions and assessed at eight weeks, 10 weeks, and four and six months after the first treatment. All patients may be eligible for open-label treatment with Liprostin at the four-month follow-up visit.

The primary endpoint of the phase 3 trial will be the measured change in maximum walking distance from baseline.

Secondary endpoints will include pain-free walking distance, limb ischemia scores and the Peripheral Arterial Disease Walking Impairment Questionnaire.

"Over 4 million Americans suffer from intermittent claudication for which there is currently no effective drug treatment available," president and chief executive officer Diane Dottavio said in the release.

"The lack of effective treatment options causes many patients with leg pain resulting from this condition to go untreated."

Endovasc is a business development company focused on acquiring and investing in innovative drug development in the areas of cardiovascular and metabolic medicine. The company is located in Montgomery, Texas.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.