PERVASIS ANNOUNCES RESULTS OF CELL THERAPY SAFETY TRIALS

Pervasis Therapeutics has announced successful initial safety results from two Phase I clinical trials of the company's first product, Vascugel. The trials were designed to study the safety of Vascugel in maintaining vascular patency in patients with arteriovenous access fistulas and arteriovenous access grafts for dialysis treatment of end-stage renal disease (ESRD).

Pervasis conducted the V-HEALTH Phase I clinical trials at four sites in the U.S. in patients with ESRD that require a permanent arteriovenous access for hemodialysis. In the studies, all 30-day primary endpoints were achieved with no significant safety issues. There was no incidence of local wound infection, and related complications were within normal limits.

The trial's data monitoring committee has recommended that Vascugel proceed to Phase II trials, following review of one-month data. The company plans to begin Phase II studies to evaluate the safety, tolerability, and general performance of Vascugel in 2007.

Vascugel is the first therapy being developed to simultaneously improve outcomes for the two primary forms of surgical arteriovenous access, namely, arteriovenous access grafts and fistulas. Vascugel is a novel allogeneic cell therapy product that restores natural repair and regeneration pathways in the vasculature. The biological activity of Vascugel allows its application to a broad array of vascular procedures where poor medical outcomes are determined by intimal hyperplasia, stenosis and loss of patency at the site of intervention.