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

Company to Hold a Conference Call Tomorrow (Tuesday) at 8:30 am EDT to

Discuss the Clinical Trial

Valley Cottage, NEW YORK, September 10 /PRNewswire-FirstCall/ -- XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB; LSE: XTL; TASE: XTL) today announced the initiation of a Phase IIb clinical trial of Bicifadine - a serotonin and norepinephrine reuptake inhibitor (SNRI) - for the treatment of diabetic neuropathic pain.

Bicifadine is being developed for the treatment of diabetic neuropathic pain which represents a significant unmet medical need in the rapidly growing multi-billion dollar neuropathic pain market. Bicifadine is a member of the SNRI drug class, a proven class in the treatment of diabetic neuropathic pain. Bicifadine's efficacy in reducing pain has been clearly demonstrated in over 15 clinical trials in acute pain, and its favorable safety profile has been established in over 3,000 patients. Importantly, Bicifadine has a unique ratio of reuptake inhibition of serotonin versus norepinephrine, which differentiates it from other members of the SNRI drug class.

The Phase IIb trial that was launched today is aimed at demonstrating the efficacy of Bicifadine in diabetic neuropathic pain, using a study design that is similar to the successful registration trials of Cymbalta(R), a member of the SNRI class that is approved for this indication, and other approved agents for neuropathic pain.

The Phase IIb study is a randomized, double-blind, placebo-controlled study comparing 200mg 3x/day (tid) and 400mg 3x/day (tid) of Bicifadine versus placebo, with a 1:1:1 randomization between the three arms, in patients with diabetic neuropathic pain. The Phase IIb study is designed to enr
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