June 24, 2010 – The first cohort of patients was fully enrolled this week in a clinical study of a new drug meant to prevent restenosis in patients with peripheral arterial disease (PAD). Specifically, PVS-10200, developed by Pervasis Therapeutics, is supposed to keep PAD patients who undergo an angioplasty and stent procedure in the superficial femoral artery from developing restenosis.
“The Phase 1/2 study of PVS-10200 will help evaluate this therapy as an adjunct to an angioplasty and stent procedure in real-world practice,” said Dr. Jean-Marc Alsac of Hopital Europeen Georges Pompidou, Paris. “New therapies that could help re-establish healthy vasculature, such as PVS-10200, would provide a valuable treatment option for physicians and patients. PVS-10200 is quickly and easily administered through a minimally invasive procedure and does not extend hospitalization time for patients.”
PVS-10200 is a biologically active therapy developed using tissue-engineered allogeneic endothelium, and is designed to reestablish healthy vasculature following common interventions to treat PAD and potentially other conditions.
The open-label dose escalation trial will evaluate the safety and impact of PVS-10200 on the incidence of major adverse events. Secondary endpoints will include the rate of primary patency and restenosis, and the time to re-intervention. The first cohort includes 11 patients. Approximately 20 patients are expected to enroll in the second cohort and will receive a higher dose of PVS-10200. Initial study results from the first patient cohort are expected at the end of 2010.