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.