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Pervasis Therapeutics Receives FDA Clearance for Pivotal Phase 3 Trial of Vascugel(R)
Date:2/1/2010

an AV fistula or AV graft for hemodialysis. Results showed that Vascugel was well tolerated, with no difference in early complication rates between the Vascugel and placebo groups at four weeks (10.9 percent vs. 21.1 percent, respectively). Results also demonstrated a trend for improved primary patency at 24 weeks in patients treated with Vascugel compared to placebo.

Building on the successful results to date for Vascugel, Pervasis continues to apply its proprietary endothelial technology platform to develop additional therapies to treat vascular disease. Data for PVS-10200, a preclinical compound being developed to treat interventions performed for peripheral arterial disease (PAD), were published in the December issue of the Journal of Vascular and Interventional Radiology (Nugent et al. J Vasc Interv Radiol 2009; 20(12):1617-1624). In a preclinical model of PAD, administration of PVS-10200 at the time of angioplasty and stent placement enhanced blood vessel healing compared to angioplasty and stenting alone. Pervasis is now preparing to begin a Phase 1/2 study of PVS-10200 in the first half of 2010.

About Pervasis

Pervasis Therapeutics, Inc. is a clinical stage company developing a broad portfolio of biologically active therapeutics. Building on its deep understanding of the specialized role that the endothelium plays in regulating natural healing and repair processes associated with disease, Pervasis is advancing groundbreaking new therapies to dramatically improve the outcomes of common vascular interventions, 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. The company's most advanced program, Vascugel®, has demonstrated proof of concept and safety in two Phase 2 trials in patients undergoing arteriovenous access procedures for hemodialysis. Pervas
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SOURCE Pervasis Therapeutics, Inc.
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