CRESSKILL, N.J., Aug. 29, 2022 /PRNewswire/ -- Vascular Therapies, Inc. a clinical-stage biopharma company focused on improving vascular access outcomes in patients with kidney disease, today announced that the first patient in the ACCESS 2 clinical trial was enrolled at by Dr Nikhil Kansal at Harbor-UCLA Medical Center in Torrance, CA.
The Phase 3 prospective randomized ACCESS 2 study will enroll 120 patients from centers in the U.S. and U.K. The study is being conducted to validate an encouraging subgroup analysis from the first Phase 3 (ACCESS) study that showed that Sirogen use in ESRD patients 65 years and older resulted in clinically meaningful improvement in AV fistula maturation and durability.
Dr Kansal, the Division Chief of Vascular and Endovascular Surgery commented "We are excited to participate in this randomized clinical trial that addresses an important unmet clinical need. The elderly population is the fastest growing segment of the hemodialysis population and these patients urgently need a solution to improve AV fistula maturation."
Sriram Iyer, MD, Chief Scientific Officer of Vascular Therapies commented "initiating enrollment of the ACCESS 2 clinical study is an important milestone for Vascular Therapies. We'd like to thank our investigators and their research teams for their interest in Sirogen and desire to evaluate a new potential therapy for hemodialysis patients."
About Vascular Therapies, Inc.
Vascular Therapies is a privately held, biopharma company developing Sirogen, a proprietary 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 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 U.S. and E.U. The FDA has tentatively approved the proprietary trade name Sirogen. Sirogen is an investigational product and has not been determined to be safe and effective for any use. For more information, please go to www.vasculartx.com.
Chief Executive Officer
Vascular Therapies, Inc.