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Pervasis Receives Orphan Drug Designation in Europe for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Date:3/1/2011

chief executive officer of Pervasis. "Receiving Orphan Drug Designation in the EU is an important step, as it will help to advance the development process, and enhance our ability to deliver our novel cell-based therapeutic approach to address this significant unmet medical need."

Vascugel has demonstrated proof of concept in two Phase 2 clinical trials involving patients with ESRD who require a permanent arteriovenous (AV) access in order to undergo hemodialysis. In these trials, Vascugel exhibited an excellent safety profile, and encouraging efficacy trends were observed, including improved duration of patency (or unimpeded blood flow) and a delay in time to first intervention as compared to placebo.

In 2009, Pervasis received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Vascugel in patients with ESRD. Pervasis announced last month that the FDA had granted Fast Track review status for Vascugel. Last year, Pervasis reached an agreement with the FDA for a Phase 3 clinical trial of Vascugel under the Agency's Special Protocol Assessment (SPA) procedure, whereby FDA formalized its agreement that the design of the Phase 3 trial was acceptable to support a regulatory submission seeking new drug approval.

Failure of Hemodialysis Access Leads to Poor OutcomesDuring 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 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.

Due to an inflammatory cascade triggered by surgical intervention, the vascular access often has difficulty healing, and quickly becomes unusable or clots rapidly, prompting the need for a
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SOURCE Pervasis Therapeutics, Inc.
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