Vascular Therapies announced today that a Phase 3 clinical trial of its Sirogen sirolimus formulation showed encouraging outcomes.
Cresskill, N.J.-based Vascular Therapies designed its Sirogen proprietary sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels. The Phase 3 clinical trial evaluated Sirogen in elderly end-stage renal disease patients, according to a news release.
Results from the randomized, controlled, multicenter Acess study of 243 patients across 20 U.S. sites evaluated the safety and effectiveness of Sirogen in improving outcomes for patients undergoing the surgical creation of an arteriovenous fistula (AVF) to provide vascular access for hemodialysis.
Fistula sustainability for dialysis at six months, the study’s primary endpoint, was not achieved. Still, Vascular Therapies noted that exploratory subgroup analyses reflected important potential benefits for ESRD patients aged 65 and older who required an AVF for dialysis.
Among the improvements brought on by Sirogen were overall AVF maturation, improved forearm AVF maturation, suitability for dialysis at 12 months and secondary patency.
Vascular Therapies chief scientific officer Dr. Sriram Iyer said in the release that the study’s findings address an “important unmet need” for those elderly dialysis patients.
“We are pleased with several positive clinical findings from the Access study and are collaborating with the FDA to design another clinical trial to validate the results,” Vascular Therapies CEO John McDermott said. “While we finalize the next study design, we will explore financing and strategic partnership opportunities. I’d like to thank our investors for their support and the talented team at Vascular Therapies for their efforts and dedication to develop Sirogen for patients requiring hemodialysis.”