Vascular Therapies’ Sirogen Sirolimus Formulation Evaluated in ACCESS Trial

April 29, 2021—Vascular Therapies, Inc. announced clinical results from the phase 3 ACCESS clinical trial of Sirogen, the company’s sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels. The company advised that the results showed encouraging arteriovenous fistula (AVF) outcomes in elderly end-stage renal disease (ESRD) patients.

The company started the ACCESS study after achieving positive clinical results from a phase 2 clinical study composed of 30 patients treated by two surgeons at two international sites.

The phase 3 United States randomized, controlled, multicenter ACCESS clinical trial enrolled 243 patients with ESRD and chronic kidney disease from 20 sites in the United States that included 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 AVF to provide vascular access for hemodialysis.

Vascular Therapies stated that 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 ages 65 years and older who required an AVF for dialysis, namely:

• Improved overall AVF maturation
• Improved radiocephalic AVF maturation
• Improved suitability for dialysis at 12 months
• Improved secondary patency

Maria DeVita, MD, Senior Nephrologist at Lenox Hill Hospital in New York, New York, and Medical Monitor for the study, commented in Vascular Therapies announcement, “The clinical results from the ACCESS study are very encouraging, especially for ESRD patients age 65 and older, who represent 50% of the hemodialysis population in the United States. Additionally, there were no unexpected adverse events, confirming the overall favorable safety profile of the product.”