ARK PLANS TO LAUNCH STUDY IN VASCULAR ACCESS GRAFT PATIENTS

Ark Therapeutics announced it has held a meeting with the FDA at which the agency agreed that a single Phase III trial will be acceptable for the basis of a marketing approval of Trinam, the company's gene therapy to prevent blood vessels from becoming blocked in kidney dialysis patients who have undergone vascular access graft surgery.

The Phase III study is being planned as a multicenter, randomized, controlled trial of up to 250 patients 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 graft for vascular access. The primary endpoint of the trial will be the time to graft failure.

Ark reported the preliminary results from a ongoing, open-label, standard-care-controlled Phase II trial in August 2006 showing that the access grafts of low-dose patients remained functional for dialysis on average more than five times longer (17.8 months) than control patients in the trial (3.3 months). No serious side effects were exhibited other than those consistent with the nature of the operation and condition.

As part of the overall Trinam program, Ark also announced that it intends to undertake a small preclinical study investigating biodistribution in an "end-to-side" procedure for surgical placement of the graft. If the results of this trial are in line with expectations, it will allow the Phase III trial to include this procedure alongside the "end-to-end" placement procedure. The Phase III study is expected to commence in mid-2007 and to last for approximately 18 months.