Vascular Therapies has announced that the first patient in the ACCESS 2 clinical trial was enrolled by Nikhil Kansal at Harbor-UCLA Medical Center in Torrance, USA.
The Phase 3 prospective randomised ACCESS 2 study will enrol 120 patients from centres in the USA and UK. The study is being conducted to validate an encouraging subgroup analysis from the first Phase 3 (ACCESS) study that showed that Sirogen use in end-stage renal disease (ESRD) patients 65 years and older resulted in clinically meaningful improvement in arteriovenous fistula (AVF) maturation and durability.
Kansal commented: “We are excited to participate in this randomised clinical trial that addresses an important unmet clinical need. The elderly population is the fastest growing segment of the haemodialysis population and these patients urgently need a solution to improve AV fistula maturation.”
Sriram Iyer, chief scientific officer of Vascular Therapies commented: “Initiating enrolment of the ACCESS 2 clinical study is an important milestone for Vascular Therapies. We would like to thank our investigators and their research teams for their interest in Sirogen and desire to evaluate a new potential therapy for haemodialysis patients.”
Vascular Therapies advises that the Sirogen drug development programme has received Fast Track status from the US Food and Drug Administration (FDA).