Study Shows Cell Therapy Treatment Following Angioplasty, Stent Placement Enhances Vascular Repair


May 19, 2009

May 19, 2009 - Pervasis Therapeutics Inc. today announced new preclinical data for its minimally invasive cell therapy, PVS-10200, which is used following an intervention for peripheral arterial disease (PAD), resulted in a statistically significant increased lumen area, reduced intimal area and decreased occlusion compared to control.

PVS-10200 (tissue engineered allogeneic endothelial cells) data were presented in an oral presentation today at EuroPCR, the official congress of the European Association of Percutaneous Cardiovascular Interventions in Barcelona, Spain. In this preclinical study, researchers evaluated treatment with ultrasound-guided percutaneous administration of PVS-10200 to the outside of porcine femoral arteries immediately following angioplasty and stent placement. Animals in the control group received angioplasty and stents with no further treatment (sham standard of care control). A third group was treated with injection of matrix alone. A total of 36 femoral arteries were evaluated in the study and evaluations were conducted at 30 and 90 days following treatment. At 90 days, PVS-10200 treated arteries had significantly decreased intimal area (3.3 ±. 0.4 mm”) compared to control (6.2 ± 0.5 mm”, P<0.05) and increased lumen area (20.4 ± 0.7 mm”) compared to control (16.1 ± 0.9 mm” P<0.05). After 90 days, PVS-10200 treated arteries had a 50 percent decrease in percent occlusion compared to sham control (P<0.05). Treatment with the gelatin matrix alone did not differ significantly from the sham control.

“Restenosis, or narrowing of the arteries, following procedural treatment for PAD occurs frequently and is associated with a number of vascular complications and re-interventions,” added Helen M. Nugent, Ph.D., co-founder and vice president, research and development at Pervasis and co-author of the study. “PVS-10200 provides endothelial-based factors to the injured artery, which regulates the inflammatory response within the blood vessel and promotes natural healing. Results from this study indicate that PVS-10200 may offer a novel therapeutic option that can effectively reduce the intimal area and reduce occlusion, and therefore limit restenosis following treatment for PAD.”

Pervasis has demonstrated proof-of-concept for this novel cellular approach in two phase II trials with Vascugel, the company’s first cellular treatment developed using its proprietary technology platform, in patients with end stage renal disease receiving arteriovenous (AV) access for hemodialysis. The two studies, known as V-HEALTH, showed that perivascular placement of Vascugel at the time of AV access creation resulted in higher patency rates, extended time to first intervention and greater lumen diameter at six months. Results also showed that treatment with Vascugel was safe with fewer thrombic events, early complications and interventions than compared to placebo. Additionally, positive efficacy trends were shown in various other secondary endpoints.

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