Veloxis Pharmaceuticals A/S Announces Preliminary Analysis of STRATO Study Suggesting Reduction in Tremor in Kidney Transplant Patients

Veloxis Pharmaceuticals A/S announced results of a preliminary analysis from the first 16 patients in its Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO) clinical trial. Results from the first 16 patients demonstrated a trend toward a reduction in tremor following the switch from twice-daily tacrolimus to once-daily LCP-Tacro. In the open-label STRATO trial, kidney transplant patients who were stable on twice-daily tacrolimus and had a complaint of tremor were switched to once-daily LCP-Tacro. Tremor was evaluated by independent neurologists, pre and post conversion to LCP-Tacro, using the Fahn-Tolosa-Marin tremor rating scale (FTM-TRS), the Tremorometer, an accelerometry instrument that measures frequency and amplitude of tremor and by PGI (Patient Global Impression of Change), a validated seven-point scale to assess change in amount of tremor reported by patients. The primary endpoint of the trial is the mean change from baseline in the FTM tremor rating scale for overall tremor score seven days after LCP-Tacro conversion. The preliminary analysis of available data on 16 subjects showed improvement in FTM rating scales, reduction in tremor amplitude by tremorometer recordings and PGI rating improvements. The study continues to enroll and final data is expected in the first half of 2013. The interim study results will be submitted for presentation at upcoming scientific meetings.