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Pervasis Receives FDA Fast Track Status for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Date:2/8/2011

pace by which we can develop and deliver this potentially transformational cell-based therapy to improve patient outcomes."

In May 2009, Pervasis received Orphan Drug Designation from the FDA for Vascugel in patients with ESRD.  Last year, Pervasis announced that it had reached an agreement with the FDA for a Phase 3 clinical trial of Vascugel under the Agency's Special Protocol Assessment (SPA) procedure. Through the SPA procedure, FDA formalized its agreement that the design of the Phase 3 trial was acceptable to support a regulatory submission seeking new drug approval. Pervasis is also awaiting official Orphan Drug Designation from the European Medicines Agency (EMA) after receiving a positive opinion on its application from The Committee for Orphan Medicinal Products (COMP) late last year.

Failure of Hemodialysis Access Points Leads to Poor OutcomesESRD is an advanced and irreversible condition treated mainly by hemodialysis or kidney transplantation. It is estimated more than 350,000 Americans with ESRD receive hemodialysis, a blood purification therapy designed to replace critical kidney functions – such as filtering waste.

During hemodialysis, blood is removed from the body, filtered through a dialyzer, or artificial kidney, and then returned to the body. Patients must undergo a surgical intervention to create a vascular access point that enables blood to flow from the body to the dialyzer and back to the body. AV fistulae (created by directly joining an artery and vein) and AV grafts (created using a synthetic tube to join an artery and vein) are the two primary types of hemodialysis access points.

Due to an inflammatory cascade triggered by surgical intervention, these vascular access points often have difficulty healing, and quickly become unusable or clot rapidly, prompting the need for additional, recurring surgeries to create new access points and also leading to multiple complications. Up to 60 percent of
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SOURCE Pervasis Therapeutics, Inc.
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