Liprostin™ Clinical Trials

In January 2001 the Phase I clinical trial established that Endovasc's liposomal formulation increased the safety and maximum tolerated dose (MTD), while decreasing the side effects in healthy volunteers.

In 2003-2004 the Company conducted a Phase II trial involving approximately 80 patients suffering from peripheral artery occlusive disease (PAOD) but who did not require or were not candidates for peripheral angioplasty. Sites for the study were located in eastern Europe and Mexico.

The purpose of the Phase II study is to identify the optimal dose range, examine the safety profile, and determine if Liprostin could benefit patients with the disease in earlier stages of PAOD, specifically Fontaine's stages IIa, IIb, and III.

Patients in early stage PAOD significantly outnumber those requiring angioplasty, therefore extending the potential medical benefits of Liprostin to a larger population base.