Special Protocol Assessment (SPA) approval has been given to Ark Therapeutics Group plc of London for a phase III pivotal trial of Trinam, a novel gene-based medicine to prevent blood vessel blockage in kidney dialysis patients who have undergone vascular access graft surgery.
Results of a phase II open-label, non-randomized trial showed that access grafts of patients who received the planned dose of Trinam exhibited almost three times the primary unassisted patency compared with controls.
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The phase III study will be a U.S. multicenter, randomized, controlled trial in which Trinam’s efficacy and safety will be investigated in patients with end-stage renal disease requiring vascular access for hemodialysis. While the SPA was reviewed, Ark conducted a preclinical study and provided extra biodistribution data on an “end-to-side” surgical procedure for placement of the graft.
The resulting data were in line with previous findings, allowing the phase III trial to include this procedure alongside the existing “end-to-end” placement procedure used in phase II.
In addition to beginning work on the phase III trial, the company intends to apply to the FDA for fast-track designation.
