CAMBRIDGE, Mass., Jan. 20, 2011 /PRNewswire/ — 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 outcom
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