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XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of Diabetic Neuropathic Pain
Date:9/10/2007

oll approximately 330 patients. Approximately 45 clinical centers in the United States, Europe and India will participate in the study. Following randomization, all patients will enter a 2-week titration period to allow them to gradually escalate up to their target treatment dose. This will be followed by a 12-week steady-state treatment period at the target treatment dose. The primary endpoint of the study is to compare the efficacy of each of the two active doses of bicifadine (200mg tid and 400mg tid) versus placebo in reduction of pain associated with diabetic neuropathy, at baseline (at the time of randomization) versus week 14 (week 12 of the steady-state phase). Pain will be measured based on a 24-hour pain rating using the 11-point Pain Intensity Numeric Rating Scale (formerly referred to as the LIKERT scale).

The lead investigators in the study are Dr. Andrew Boulton, M.D. and Dr. Sherwyn Schwartz, M.D. Dr. Boulton is Professor of Medicine, Division of Endocrinology, Diabetes and Metabolism, at the University of Miami and the University of Manchester, UK. Professor Boulton has been active in clinical research in diabetic neuropathy over the last 25 years and has published over 250 peer reviewed articles on the subject. He was co-chair of the committee that formulated the American Diabetes Association statement on diabetic neuropathy published in Diabetes Care in 2005. Dr. Schwartz is Chief Executive Officer and Chief Medical Officer of DGD Research, Inc. which is the largest diabetes and endocrinology practice in the United States. Dr. Schwartz has over 20 years of clinical research experience in diabetes and diabetic complications, and has participated in hundreds of clinical trials in the field.

Dr. Christine Sang, Director of Translational Pain Research at the Brigham and Women's Hospital, Harvard Medical School, and Chair of XTL's Scientific Advisory Board, commented, "Based on the evidence for the role of SNRI's in the treatment of neuropat
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SOURCE XTL Biopharmaceuticals Ltd
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