Pervasis to present PVS-10200 interim data from Phase 1/2 PAD clinical study at IC3D

Jan 21 2011

Pervasis Therapeutics, Inc. today announced it will present interim data from the company's Phase 1/2 clinical study of PVS-10200, an investigational cell-based therapy under development to prevent restenosis in patients with peripheral arterial disease (PAD) who undergo an angioplasty and stent procedure in the superficial femoral artery. Jean-Marc Alsac, MD, Associate-Faculty in Vascular Surgery, Department of Cardiovascular Surgery, Hopital Europeen Georges Pompidou, Paris, and principal investigator of the study, will present the findings at the Sixth Annual International Conference on Cell Therapy for Cardiovascular Disease (IC3D) today in New York City.

Dr. Alsac will report initial 6-month data from the open-label dose escalation study designed to evaluate the safety, feasibility and impact of PVS-10200 on the incidence of major adverse events. Secondary endpoints include the rates of target lesion revascularization, primary patency and restenosis.  In June 2010, Pervasis announced the first cohort of patients had been fully enrolled in the study. Enrollment in a second cohort is ongoing.  The study is being conducted at Hopital Europeen Georges Pompidou, and two other hospitals in France, Hopital Bichat and Centre Hospitalier Universitaire d'Amiens.

"Although most revascularization procedures of the superficial femoral artery have high initial success rates, restenosis is a common occurrence within a year after surgery, leading to poor outcomes and the need for repeat procedures," said Dr. Alsac. "I am highly encouraged by the initial findings of the study. The low rate and nature of adverse events reported thus far demonstrate the potential of PVS-10200 as a safe, viable and minimally invasive option to treat vascular injury and improve outcomes for patients."

Pervasis is a clinical stage company focused on developing breakthrough therapies with the potential to improve outcomes following common vascular surgical and interventional procedures, such as arteriovenous access, angioplasties, stents and peripheral and coronary bypass grafts -- the failure of which result in serious complications and a significant increase in medical costs. There are no currently approved therapies that directly target the underlying physiological processes leading to serious vascular complications, including inflammation, thrombosis (the formation of a blood clot inside a blood vessel) and restenosis (the re-narrowing of a coronary artery after it has been treated with angioplasty or stenting).