Pervasis Therapeutics Presents Data at American Society of Nephrology Meeting
Pervasis Therapeutics Presents Safety Data from Phase 1 and 2 Clinical Trials of Vascugel® at the American Society of Nephrology Annual Meeting New clinical data show excellent safety profile for novel therapy that may promote natural healing and regeneration of the vasculature in dialysis patients needing permanent AV access
CAMBRIDGE, Mass. – November 6, 2008 – Pervasis Therapeutics, Inc., a biotechnology company pioneering biologically active therapies and devices to treat serious illnesses, today 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 data were presented during a poster session at the American Society of Nephrology Annual Meeting in Philadelphia on November 6, 2008.
“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.” According to the United States Renal Data System, the number of ESRD patients requiring hemodialysis in 2006 was over 325,000. Medicare data shows that vascular access complications account for up to 25 percent of all hemodialysis patient admissions. The majority of vascular access is achieved through the surgical creation of synthetic AV grafts or autogenous AV fistulae. Vascular access failure is the single most important cause of morbidity in the hemodialysis population.
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 statistically significant 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.
“We are highly encouraged by these data that demonstrate patients treated with Vascugel® had lower incidences of complications following the creation of AV access grafts and fistulae for hemodialysis,” said Frederic Chereau, president and chief executive officer of Pervasis. “Vascugel® is the first cell therapy being developed to improve outcomes for dialysis patients needing surgical AV access and we will be presenting the efficacy data from the two Phase 2 studies with Vascugel® later this month. We anticipate launching a larger Phase 3 trial to confirm these observations and trends in 2009.”
About Vascugel® Vascugel® is a novel and unique allogeneic cell therapy product under investigation for enhancing repair, extending patency and vascular health. Vascugel® builds on concepts of tissue engineering to enable implantation of allogeneic endothelial cells in a controlled state. When placed adjacent to an injured blood vessel, the endothelial cells in Vascugel® provide growth regulatory compounds to the underlying blood vessel, which promotes a natural healing process and may prevent excessive, inflammation, thrombosis and stenosis. Vascugel® has been studied in two Phase1/Phase 2 clinical trials in patients with end stage renal disease.
About Pervasis Therapeutics, Inc. Pervasis Therapeutics, Inc. is a clinical-stage regenerative therapeutics company developing biologically active products to address complex diseases and unmet medical needs. The Company has developed a proprietary allogeneic endothelial cell technology to regulate vascular repair and restore blood flow to critical vasculature and organs. Pervasis is also exploring broader indications in non-vascular applications, including inflammation, organ transplantation, nerve, wound and bone repair, and oncology. For more information, please visit www.pervasistx.com<http://www.pervasistx.com>.
### CONTACT: Maggie O’Toole, Pervasis Therapeutics, Inc. (617) 871-1201
Michele Rozen, Pure Communications
Posted: November 2008