Ark Therapeutics wins approval to initiate Phase III renal disease study12th January 2009
By Staff Writer
UK-based Ark Therapeutics Group has completed the work requested by the FDA to qualify a potency test for Trinam. As a result, the company has now been notified by the FDA that it can commence patient recruitment into its Trinam Phase III trial.
The Phase III study is a US multi-center, randomized, controlled trial, in which the efficacy and safety of Trinam will be investigated in patients with end-stage renal disease (ESRD) requiring vascular access for hemodialysis. Patients with ESRD will be randomized to receive either Trinam in addition to standard care or standard care alone at the time of surgical placement of a synthetic PTFE graft for vascular access.
Primary unassisted patency (time to any first intervention) will be the primary regulatory endpoint and overall patency and a number of other important pre-defined clinical endpoints will also be measured. Safety will be assessed by an independent data and safety monitoring board against a pre-specified set of stopping rules defined during the special protocol assessment.
Trinam is Ark's gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. The product is an adenovirus-mediated VEGF D gene delivered with a novel biodegradable local delivery device.
Nigel Parker, CEO of Ark, said: "Following finalization of the test work and acceptance of the assay by the FDA, we are delighted now to be commencing patient recruitment in the Phase III trial for Trinam. Maintenance of graft access for kidney dialysis patients is vital for their survival, making this an area of high clinical need for which we are hopeful that this pioneering gene-based medicine can provide a solution."
http://www.pharmaceutical-business-review.com/article_news_print.asp?guid=F4BE5368-0A2E-4082-AB26-289D155FEFF2
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