Endovasc submits protocol for phase III Liprostin trial

Intermittent claudication occurs when the arteries that supply blood to the legs become clogged with fatty deposits. This painful condition includes aches or cramps in the calf, buttock, or thigh muscles that occur when patients walk or exercise and stop when they rest.

Endovasc’s 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, 10 weeks, and four and six months after their first treatment.

At the four-month follow-up visit, patients may be eligible for open-label treatment with Liprostin. The trial will enroll approximately 60 patients located at six to 10 sites in the US.

The primary endpoint of this trial will be the measured change in maximum walking distance from baseline. The trial also consists of several secondary endpoints, which include pain free walking distance, limb ischemia scores and the peripheral arterial disease walking impairment questionnaire (PADWIQ).

“The submission of this phase IIIa protocol represents an important milestone for us and is a result of extensive work and diligence conducted by everyone at Endovasc, including tremendous support from our CRO, Synergos,” said Dr Diane Dottavio, president and CEO of Endovasc. “Armed with compelling results from our previous phase II study, we are eager to begin enrolling clinical sites.”