• Ark Therapeutics Group plc, of London, enrolled the first patient in a Phase III study of Trinam, its gene-based compound to prevent blood vessel blocking in kidney dialysis patients who have undergone vascular access graft surgery. The product is an adenovirus-mediated VEGF D gene delivered with a biodegradable local delivery device. The study is a randomized, controlled trial investigating the efficacy and safety of Trinam in patients with end-stage renal disease requiring vascular access for hemodialysis. Patients will 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. Time to any first intervention will be the primary regulatory endpoint. Overall patency and a number of other important predefined clinical endpoints also will be measured.

• Stem Cell Therapeutics Corp., of Calgary, Alberta, said that as a result of the FDA lifting a Phase IIb clinical hold and encouraging results from Phase IIb patients enrolled prior to the hold, it will begin a modified Phase IIb REGENESIS NTx-265 stroke trial as soon as possible with the goal of completing patient enrollment by the end of this year. The company said it unblinded results from the seven patients in the halted Phase IIb trial and found results that were encouraging and consistent with the Phase IIa results announced in February.

• Transcept Pharmaceuticals Inc., of Richmond, Calif., presented positive data on the safety and efficacy of 3.5 mg zolpidem tartrate sublingual tablet (ZST) when taken on an as-needed basis for the treatment of middle-of-the-night (MOTN) awakenings. Results indicated that compared to placebo, ZST significantly reduced latency to sleep onset after MOTN awakenings, improved sleep quality and next-day alertness ratings, and significantly improved the post-MOTN sleep maintenance parameters of wake after sleep onset and number of awakenings vs. placebo. ZST was well tolerated, and no safety issues were identified. Data were presented at the 2009 annual meeting of the American Psychiatric Association in San Francisco.