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Pervasis renal disease drug fast-tracked

Pervasis Therapeutics has been granted fast-track status by the US Food and Drug Administration for Vascugel, a potential new drug for renal disease

Pervasis Therapeutics has been granted fast-track status by the US Food and Drug Administration (FDA) for Vascugel, a potential new drug for the prevention of haemodialysis access failure in patients with end stage renal disease.

The drug, which is the company's lead product, is intended to regulate the body's healing response after surgical interventions to create vascular access points for hemodialysis. Without such treatment, the access points often have difficulty healing and become unusable, leading to multiple complications and additional surgeries, according to the company.

Vascugel, a novel endothelial cell-based therapy, has demonstrated clinical proof of concept in two phase II trials.  The studies, which enrolled patients with end stage renal disease who require a permanent arteriovenous access for haemodialysis, showed that Vascugel offered an improved duration of unimpeded blood flow and a delay in time to first intervention compared to placebo.

The FDA's fast-track programme is designed to speed the development and review of new drugs and vaccines that treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Under the programme, companies can submit portions of the marketing application to the FDA for review as they are completed.

In addition, the sponsor company of a fast-tracked drug or vaccine is eligible for more frequent meetings and written correspondence with the FDA, and the product candidate is generally eligible for an accelerated approval, which is an approval based on surrogate endpoints.

Vascugel received orphan drug status from the FDA in 2009. The orphan designation, which is intended to encourage development of drugs for conditions that affect fewer than 200,000 Americans, carries potential benefits including tax breaks, research funding, and seven years of US marketing exclusivity.

9th February 2011

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