Ph III trial of Ark's Trinam gets SPA
UK-based Ark Therapeutics says that, following full review by the US Food and Drug Administration, the application for Special Protocol Assessment for a Phase III trial of Trinam, its developmental gene therapy for the prevention of hemodialysis blockage, filed in April 2007, has been successful and the FDA has formally given SPA approval.
In parallel, the updated Investigational New Drug application for the trial has also been separately reviewed and approved by the agency, subject to a requirement for the company to qualify one product release test relating to potency, prior to enrolling patients.
The compound is Ark's novel gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. The firm will now commence work to start the planned Phase III trial and, in addition, intends to apply to the FDA for Fast Track Designation.
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