Research & Development
Vascular Therapies Posts Clinical Results from Its Phase 3 Randomized Multicenter Clinical Trial
30 April 2021 - - US-based biotechnology company Vascular Therapies, which is developing Sirogen, a proprietary sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels, has announced clinical results from its Phase 3 clinical trial in which Sirogen showed encouraging AV fistula outcomes in elderly end-stage renal disease patients, the company said.

Following positive clinical results from a Phase 2 clinical study (n=30; 2 international sites, 2 surgeons), the company embarked on the ACCESS study, a Phase 3 US randomized, controlled, multicenter clinical trial.

The ACCESS study enrolled 243 patients with end stage renal disease and chronic kidney disease from 20 US sites, including 20 nephrologists and 26 surgeons.

The study was designed to evaluate the safety and effectiveness of Sirogen to improve outcomes in patients undergoing the surgical creation of an arteriovenous fistula to provide vascular access for hemodialysis.

The primary endpoint of fistula suitability for dialysis at 6 months was not achieved; however, in exploratory subgroup analyses that reflected the demographics of the enrolled population, the ACCESS study revealed important potential benefits for ESRD patients age 65 and older who required an AVF for dialysis, namely improved overall AVF maturation; improved forearm (radio-cephalic) AVF maturation; improved suitability for dialysis at 12 months; and improved secondary patency.

Chronic kidney disease, reduces a person's ability to effectively filter blood, causing wastes to build up in the body.

Advanced CKD can progress to kidney failure, often referred to as end-stage renal disease, which requires dialysis or transplantation to survive.

The majority of ESRD patients undergo chronic hemodialysis, which requires functioning vascular access to connect the patient's bloodstream to a hemodialysis machine three times a week for this life-saving treatment.

The preferred form of vascular access for hemodialysis is an arteriovenous fistula, created by connecting a vein to an artery.

Vascular Therapies is a biotechnology company that has developed Sirogen, a proprietary sirolimus formulation for local, perivascular drug delivery to reduce surgical stenosis in blood vessels.

The goal of this therapeutic approach is to improve vascular surgery outcomes in patients with kidney and vascular diseases.

This investigational therapy is currently being evaluated in a Phase 3 program. The drug's development has received Fast Track status from the FDA and sirolimus has Orphan Drug designation for dialysis vascular access indications in the US and E.U.

FDA has tentatively approved the proprietary tradename Sirogen for VT's formulation of sirolimus for intraoperative use.

Sirogen is an investigational product and has not been determined by the FDA to be safe and effective for any use.
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