Vascular Therapies is developing Sirogen, a proprietary sirolimus formulation for intraoperative local, perivascular drug delivery focused on improving vascular access outcomes in patients with kidney disease. Daniel G Clair, vascular surgeon and chairman of the Department of Surgery at Palmetto Health-USC Medical Group in Columbia, USA, presented preliminary results from the company’s clinical development programme at the recent Eastern Vascular Society Meeting (EVS; 5–7 June, Pittsburg, USA).
The presentation included outcomes of two cohorts—a non-randomised phase 2 (n=30; two international sites, two surgeons) and the open label subset (OL; n=26; 20 U.S. sites, 26 surgeons) of the ACCESS study, an ongoing, randomised controlled, multicentre US phase 3 trial. For the composite study group of 56 patients:
- 78% and 73% of AVF were suitable for dialysis at six and 12 months respectively
- Median time to first dialysis was 49 days
- 12-month secondary patency was 73%
- No product related serious adverse events were reported
These outcomes provide a strong efficacy signal. Enrolment in the ACCESS study was completed in August 2019 and included 243 patients. The six-month primary endpoint (Fistula suitability for dialysis at six months) results are expected to be announced in the second quarter of 2020.
Clair commented “these preliminary results are very encouraging and suggest that intraoperative perivascular sirolimus may improve AV fistula outcomes in dialysis patients. We look forward to seeing the primary endpoint results from the randomised cohort.” Maria DeVita, chief of Nephrology at Lenox Hill Hospital in New York, USA and medical monitor for the study.