Vascular Therapies Initiates ACCESS 2 Trial of Sirogen for Improving AV Fistula Maturation in ESRD Patients

August 29, 2022—Vascular Therapies, Inc. announced that the commencement of the ACCESS 2 clinical trial. The phase 3 prospective randomized ACCESS 2 study will enroll 120 patients from centers in the United States and the United Kingdom.

According to Vascular Therapies, the study is being conducted to validate an encouraging subgroup analysis from the first phase 3 study—ACCESS—that showed that use of the company’s Sirogen formulation in patients aged ≥ 65 years with end-stage renal disease (ESRD) resulted in clinically meaningful improvement in arteriovenous (AV) fistula maturation and durability.

Vascular Therapies is developing Sirogen, a sirolimus formulation for local, perivascular drug delivery. The goal of this therapeutic approach is to improve vascular surgery outcomes in patients with kidney and vascular diseases.

The first patient in the trial was enrolled by Nikhil Kansal, MD, at Harbor-UCLA Medical Center in Torrance, California, where Dr. Kansal is the Division Chief of Vascular and Endovascular Surgery.

“We are excited to participate in this randomized clinical trial that addresses an important unmet clinical need,” commented Dr. Kansal in the company’s press release. “The elderly population is the fastest growing segment of the hemodialysis population, and these patients urgently need a solution to improve AV fistula maturation.”

Vascular Therapies’ Sirogen drug development program has received Fast Track status from the FDA and sirolimus has Orphan Drug designation for dialysis vascular access indications in the United States and European Union. The FDA has tentatively approved the proprietary tradename Sirogen. Sirogen is an investigational product and has not been determined to be safe and effective for any use, advised the company.