Ark: new data from phase 2 trial shows effectiveness of Trinam in maintaining access grafts for dialysis

By Lisa Kerner

Charlotte, N.C., Aug. 23 - Ark Therapeutics Group plc said new data from its ongoing phase 2 trial of Trinam show that the access grafts of low-dose patients remain functional for dialysis five times longer on average (17.8 months) than control patients in the trial (3.3 months).

Of the 16 patients included in the phase 2 study, six were assigned to a low-dose group (one dose of VEGF 4 x109 viral particles), six to a high-dose group (4 x 1010 viral particles) and the remaining four to a control group receiving standard care only.

All patients in the high-dose group with successful graft implants still have open grafts with patency averaging eight months to date.

Ark said no systemic distribution of Trinam has been found in either of the dose groups and the product is well-tolerated.

Trinam is Ark's novel gene therapy to prevent blood vessels from blocking in kidney dialysis patients who have undergone vascular access graft surgery.

An artificial blood vessel (vascular access graft), surgically implanted between an artery and a vein in the forearm, is used during dialysis to gain access to the circulatory system.

These grafts often become blocked due to overgrowth of muscle tissue inside the blood vessel (intimal hyperplasia), requiring surgery.

Ark is a specialist health care group based in London.

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