Pervasis Therapeutics, Inc. announced new data from Phase 1 and 2 clinical trials of Vascugel, a novel allogeneic cell therapy product that may restore natural repair and regeneration pathways in the vasculature. Data from these trials indicate that Vascugel has an excellent safety profile in patients with end-stage renal disease (ESRD) that need permanent arteriovenous (AV) access for dialysis, with fewer thrombotic events, local wound infections, early complications and interventions compared to placebo.
‘The safety profile of Vascugel combined with a decreased incidence of early complications following surgery seen in these trials are promising,’ said Jeffrey Lawson, M.D., Ph.D., Department of Vascular Surgery, Duke University Medical Center, co-lead investigator of the trials. ‘Vascular access failure is a major complication to providing care to patients on hemodialysis with end-stage renal disease. Vascugel is a potential new treatment option that may improve outcomes for these patients.’
Overview of Clinical Trial Results
The clinical trials known as V-HEALTH (Vascular intimal Hyperplasia: Extending Arterial and venous patency, Limiting vascular Trauma, and inhibiting Hyperplasia while re-establishing vascular health) were designed to evaluate the safety of Vascugel treatment in patients with ESRD undergoing placement of an AV graft or AV fistula for hemodialysis access. A total of 65 patients were enrolled in the combined studies. The Phase 1 trials were non-randomized, open-label studies of four patients receiving AV fistulae and four patients receiving AV grafts. The Phase 2 trials were multi-center, double-blind studies of Vascugel versus placebo (Gelfoam) with 57 patients – 27 receiving an AV fistula and 30 receiving an AV graft. The Phase 2 trial patients were combined with the four patients receiving AV fistula from the Phase 1 trials for a combined intent-to-treat (ITT) total of 61 patients. The patients in the Phase 2 trials were randomized two-to-one to receive placebo or Vascugel wraps at the time of surgery. All patients were followed for 30 days post-surgery for the primary endpoint and continued to be followed for a total of 24 weeks for all other endpoints. The primary endpoint of the trials were assessed by the incidence of local wound infection, intervention (surgical, endovascular or percutaneous) and acute thrombosis within 30 days post-surgery. Safety endpoints evaluated immunological sensitization using panel reactive antibody (PRA) testing vascular patency, lumen diameter and venous remodeling.
Analyses of the primary safety endpoints of the clinical trials found that treatment with Vascugel was safe with a lower incidence of local wound infection, access intervention and acute thrombosis compared to placebo; 6.5% and 10.9% for Vascugel treated patients at two and four weeks, respectively, versus 21.1% and 21.1% for the control group. In the AV graft ITT population, treatment with Vascugel showed a decrease (5.3%, p=0.047) in the incidence of early complications compared to placebo (10.5%) at two weeks and this positive trend continued at four weeks. These results indicate that treatment with Vascugel may result in fewer complications following creation of permanent AV access for hemodialysis. There was no difference in serious adverse events between Vascugel and placebo groups. Additionally, there was no significant increase in PRA levels that lead to patency loss, adverse or serious adverse events in either group. These data build on the initial Phase 1 safety results for Vascugel that demonstrated that all primary endpoints of the study were achieved, with no significant safety issues.
Release Date: November 6, 2008
Source: Pervasis Therapeutics
