Pervasis Therapeutics, Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 clinical trial for Vascugel®, an investigational new drug for the prevention of hemodialysis access graft failure. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure. Pervasis expects to initiate the study in 2010.
"We are pleased that the FDA approved the SPA agreement and are confident that we now have a clearly defined path to submission of a Biologics License Application for Vascugel," said Fred Chereau, president and chief executive officer at Pervasis. "We look forward to beginning the Phase 3 study and to confirming the safety and efficacy results from our Phase 1/2 study in a larger patient population."
This Phase 3, single-blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of Vascugel in approximately 390 patients with end-stage renal disease (ESRD) undergoing creation of an arteriovenous (AV) graft for hemodialysis access. The primary objective of this study will be to evaluate the efficacy of Vascugel in extending the duration of primary patency (lack of vessel obstruction) as compared to standard-of-care treatment.
Under the SPA procedure, FDA formalizes its agreement that the design of the Phase 3 trial is acceptable to support a regulatory submission seeking new drug approval.
The SPA agreement follows the recent publication of positive Phase 1/2 results for Vascugel in the December issue of the Journal of Vascular Surgery (Conte et al. J Vasc Surg 2009; 50:1359-68). The study was designed to assess feasibility, safety, and preliminary effects on patency of Vascugel in patients requiring 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.
SOURCE Pervasis Therapeutics, Inc.