Vascular Therapies Completes Enrollment in the ACCESS 2 Study, a Phase III Multinational Randomized Clinical Trial of the Sirolimus Eluting Collagen Implant (Sirogen) for the Surgical Creation of Arteriovenous Fistula for Hemodialysis Vascular Access

- Trial will evaluate the effectiveness of perivascular sirolimus to improve AV Fistula outcomes in patients with kidney disease -

- ACCESS 2 topline results, including clinical fistula maturation at six months, expected in Q2 2025 -

CRESSKILL, NJ / ACCESSWIRE / August 5, 2024 / Vascular Therapies, a biotechnology company focused on improving vascular access outcomes in patients with kidney disease, today announced completion of enrollment in the ACCESS 2 trial, a Phase III prospective randomized, multicenter clinical study of Sirogen™ for the surgical creation of arteriovenous (AV) fistula in patients requiring hemodialysis vascular access.

Vascular Therapies is developing a proprietary sirolimus formulation (Sirogen) for intraoperative local, perivascular drug delivery. In a post-hoc subgroup analysis from ACCESS, the original US prospective randomized study, Sirogen showed improved fistula maturation and secondary patency when compared to standard of care controls.

The ACCESS 2 Study was designed to validate the post-hoc results from ACCESS and further evaluate the effectiveness of Sirogen to improve outcomes in patients requiring an AV fistula. This multicenter randomized study enrolled 12_ patients across 18 centers in the United States and the United Kingdom. The primary endpoint of the study is fistula maturation at six months, and results are currently expected to be announced in the second quarter of 2025.

John McDermott, CEO of Vascular Therapies said "We are very pleased to complete enrollment in this important clinical study. A functional vascular access is the lifeline for dialysis patients and although AV fistula remains the preferred vascular access for most hemodialysis patients, there is still an unacceptably high rate of failure necessitating reinterventions, increasing patient morbidity and healthcare costs. We are confident that Sirogen has the potential to provide patients with kidney disease a new therapy to improve vascular access outcomes."

Sriram Iyer, MD, Chief Scientific Officer of Vascular Therapies added "The encouraging outcomes from the original ACCESS study provide a strong signal that Sirogen has the potential to bridge an important unmet clinical need and we are optimistic that the ACCESS 2 outcomes will be confirmatory. We would like to thank the patients, physicians and research personnel and are very grateful for their cooperation and participation in this study."

About Chronic Kidney Disease, Hemodialysis and Vascular Access

Chronic kidney disease (CKD), reduces a person's ability to effectively filter blood, causing waste to build up in the body. Advanced CKD can progress to irreversible kidney failure, referred to as end-stage kidney disease (ESKD), which requires dialysis or transplantation to survive. The majority of ESKD patients undergo chronic hemodialysis, which requires a 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.

About Vascular Therapies (www.vasculartx.com):

Vascular Therapies, Inc. is a privately‑held, biotechnology company that is developing Sirogen, a sirolimus drug 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. This investigational product is currently being evaluated in a Phase III randomized clinical trial. The drug development program has received Fast Track status from the FDA and sirolimus has Orphan Drug designation for the dialysis vascular access indications in the U.S. and E.U.

Company Contact

John McDermott
Chief Executive Officer
Vascular Therapies, Inc
jmcdermott@vasculartx.com

SOURCE: Vascular Therapies