Ark reports strong data from ongoing Ph II Trianam trial

UK-based Ark Therapeutics has reported further positive results from a Phase II trial of Trinam, its novel gene therapy to prevent blood vessel blockage in kidney dialysis patients who have undergone vascular access graft surgery.

Good results for the low-dose group were first reported in October 2005, and the new data show that the access grafts of low-dose patients remain functional for dialysis on average over five times longer (17.8 months) than control patients in the trial (3.3 months). In the high-dose group, recruited after the low-dose cohort, all patients with successful graft implants still have open grafts with patency averaging eight months so far. For the primary end point of safety, no systemic distribution of Trinam has been found in either of the high or low dose groups and the product is well tolerated, the firm noted.

The Phase II trial of the agent, which is an endothelial growth factor gene in an adenoviral vector combined with Ark's biodegradable local delivery collagen collar device (EG001), is an ongoing open-label, standard-care controlled study to primarily assesses safety, with efficacy as a secondary measure.