Clinical Programs: PVS-10200 Overview

Overview: PVS-10200 is designed to reestablish healthy vasculature following common interventions to treat peripheral arterial disease (PAD) and potentially other conditions.

Phase 1/2 Trial: In April 2010, Pervasis initiated a Phase 1/2 clinical study to explore the potential of PVS-10200 to prevent restenosis in patients who undergo an angioplasty and stent procedure for the treatment of PAD. Primary endpoints for the study include safety and the impact of PVS-10200 on the incidence of major adverse events.

Preclinical Data: Data from a preclinical study of a porcine model of PAD showed that percutaneous administration of PVS-10200 at the time of angioplasty or stent placement enhanced vessel healing compared to angioplasty or stenting alone. At 90 days, porcine femoral arteries treated with PVS-10200 had significantly decreased intimal area, increased lumen area and decreased occlusion compared to angioplasty or stenting alone.

Next Steps: Initial results from the Phase 1/2 study are expected at the end of 2010.

Histological Cross Sections from a Preclinical Study of PVS-10200

Histological cross sections of arteries from a preclinical study of PVS-10200 in a porcine femoral stent model. Cross sections showed that arteries treated with PVS-10200 (C) had significantly decreased intimal area and increased lumen area compared to the two controls (A and B). I = Intima, M= Media, L = Lumen.