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The Phase 2b trial is aimed at demonstrating the efficacy of Bicifadine indiabetic neuropathic pain, using a study design that is similar to thesuccessful registration trials of Cymbalta(R), a member of the SNRI class thatis approved for this indication, and other approved agents for neuropathicpain.
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The Phase 2b study is a randomized, double-blind, placebo-controlled studycomparing 200mg 3x/day (tid) and 400mg 3x/day (tid) of Bicifadine versusplacebo, with a 1:1:1 randomization between the three arms, in patients withdiabetic neuropathic pain. Approximately 40 clinical centers in the UnitedStates, Germany, Israel and India are participating in the study. Followingrandomization, all patients enter a 2-week titration period to allow them togradually escalate up to their target treatment dose. This is followed by a12-week steady-state treatment period at the target treatment dose. Theprimary endpoint of the study is to compare the efficacy of each of the twoactive doses of Bicifadine (200mg tid and 400mg tid) versus placebo inreduction of pain associated with diabetic neuropathy, at baseline (at thetime of randomization) versus week 14 (week 12 of the steady-state phase).Pain is measured based on a 24-hour pain rating using the 11-point PainIntensity Numeric Rating Scale (formerly referred to as the LIKERT scale).
Bicifadine is being developed for the treatment of diabetic neuropathicpain which represents a significant unmet medical need in the rapidly growingmulti-billion dollar neuropathic pain market. Bicifadine is a member of theSNRI drug class, a proven class in the treatment of diabetic neuropathic pain.Bicifadine's efficacy in reducing pain has been demonstrated in over 15clinical trials in acute pain, and its safety profile has been established inover 3,000 patients. Importantly, Bicifadine has a unique ratio of reuptakeinhibition of serotonin versus norepinephrine, which differentiates it fromother members of the SNRI drug class.
Ron Bentsur, XTL's Chief Executive Officer, commented, "We are veryexcited to have completed this milestone of patient randomization ahead of ourprojected timeline, and we remain grateful for the tremendous dedication ofthe investigators who are participating in the study." Mr. Bentsur added, "Weeagerly await the outcome of this study in Q4 2008."
XTL in-licensed the world-wide rights to Bicifadine from DovPharmaceutical, Inc. (NASDAQ OTC: DOVP) in January 2007.
ABOUT XTL BIOPHARMACEUTICALS LTD.
XTL Biopharmaceuticals Ltd. ("XTL") is engaged in the development oftherapeutics for the treatment of diabetic neuropathic pain and HCV. XTL isdeveloping Bicifadine, a serotonin and norepinephrine reuptake inhibitor, forthe treatment of diabetic neuropathic pain, which is currently in a Phase 2bstudy. XTL has out-licensed its novel pre-clinical HCV small moleculeinhibitor program. XTL also has an active in-licensing and acquisition programdesigned to identify and acquire additional drug candidates. XTL is publiclytraded on the NASDAQ and Tel-Aviv Stock Exchanges (NASDAQ: XTLB; TASE: XTL).
Cautionary Statement
Some of the statements included in this press release, particularly thoseanticipating future clinical and business prospects for our clinical compoundfor neuropathic pain, Bicifadine, the likelihood of successful results from aclinical trial with Bicifadine, operating strategies and similar matters, maybe
