UK-based Ark Therapeutics has enrolled the first patient in its Phase III study of Trinam, a novel, gene-based medicine to prevent blood vessels from blocking in kidney dialysis patients who have undergone vascular access graft surgery.
The multicenter, randomized, controlled trial will test the efficacy and safety of Trinam in patients with end-stage renal disease who require vascular access for hemodialysis.
The results of a Phase II, open-label, non-randomized, standard-care controlled trial, reported in 2007, showed that Trinam remained functional for dialysis up to three times longer than control and the product was well tolerated.
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