FDA fast tracks Vascugel

FDA has granted fast-track designation to a novel endothelial cell-based therapy (Vascugel, Pervasis) for the prevention of hemodialysis access failure in patients with end-stage renal disease (ESRD).

Vascugel aims to regulate the body’s healing response following surgical interventions to create vascular access points, which are necessary for patients with ESRD undergoing hemodialysis, reducing the need for repeat surgical interventions, and improving overall patient outcomes.

“AV [arteriovenous] access failure is the most common reason for hospitalization of the more than 350,000 Americans with end-stage renal disease on hemodialysis,” said Formulary Editorial Advisor Craig I. Coleman, PharmD, associate professor of pharmacy practice, University of Connecticut School of Pharmacy, Storrs, and
co-director, UCONN/Hartford Hospital. “Any intervention that can reduce the occurrence of access failure in this population will undoubtedly have important health economic consequences.”

“Common vascular surgical and interventional procedures, such as hemodialysis access, angioplasties, stents, and peripheral and coronary bypass grafts, often result in serious complications or failure and a significant increase in medical costs,” Frederic Chereau, president and CEO of Pervasis Therapeutics, told Formulary. “Our novel cell-based therapies directly target, at the point of intervention, the inflammatory cascade responsible for these complications, enhancing the vessels’ ability to properly heal,” Chereau said.

“Fast-track designation will be an important element in helping us bring Vascugel, our lead product, to patients with end-stage renal disease as quickly as possible in order to reduce complications, limit the need for repeat procedures, and improve overall outcomes for this very sick patient population,” he said.

According to a company statement, Vascugel has demonstrated clinical proof of concept in two phase 2 clinical trials involving patients with ESRD who require a permanent arteriovenous access for hemodialysis. In these trials, the company said the agent exhibited an excellent safety profile and encouraging efficacy trends were observed, including improved duration of patency and a delay in time to first intervention as compared to placebo.