XTL Biopharmaceuticals Announces Completion of the Bicifadine Phase 2b Study for Diabetic Neuropathic Pain
October 07 2008 - 6:35AM
PR Newswire (US)
VALLEY COTTAGE, New York, Oct. 7 /PRNewswire-FirstCall/ -- XTL
Biopharmaceuticals Ltd. (NASDAQ:XTLBNASDAQ:TASE:NASDAQ:XTL)
announced today that the last patient randomized into the
Bicifadine Phase 2b clinical trial for the treatment of diabetic
neuropathic pain has completed the study. This milestone officially
marks the completion of this randomized, double-blind,
placebo-controlled Phase 2b clinical trial which enrolled 351
patients at approximately 40 sites in the United States, Germany,
Israel and India. The Company expects to report top-line results
from this study within 6-8 weeks. Bicifadine is a first-in-class
triple reuptake inhibitor for the treatment of diabetic neuropathic
pain. Bicifadine's main effect is as a serotonin and norepinephrine
reuptake inhibitor with a moderate effect on dopamine reuptake
inhibition, believed to be potentially complementary in treating
neuropathic pain. The Phase 2b trial is aimed at demonstrating the
efficacy of Bicifadine for the treatment of diabetic neuropathic
pain, using a study design that is similar to the successful
registration trials of Cymbalta(R), a dual-reuptake inhibitor of
serotonin and norepinephrine that is approved for this indication,
and other approved agents for neuropathic pain. The Phase 2b trial
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. Following randomization,
all patients entered a 2-week titration period to allow them to
gradually escalate up to their target treatment dose. This was
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 is
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 completion of the Bicifadine Phase 2b clinical trial
is an important and significant milestone for XTL," stated Ron
Bentsur, CEO of the Company, who continued, "We are grateful for
the dedication of all the investigators who participated in the
study, and we look forward to reporting top-line data from the
study later this quarter." XTL in-licensed the worldwide rights to
Bicifadine from Dov Pharmaceutical, Inc. (Nasdaq OTC: DOVP) in
January 2007. ABOUT XTL BIOPHARMACEUTICALS LTD. XTL
Biopharmaceuticals Ltd. ("XTL") is engaged in the development of
therapeutics for the treatment of diabetic neuropathic pain and
HCV. XTL is developing Bicifadine, a triple reuptake inhibitor of
serotonin, norepinephrine and dopamine, which is currently in a
Phase 2b study for the treatment of diabetic neuropathic pain. XTL
has out-licensed its novel pre-clinical HCV small molecule
inhibitor program. XTL is publicly traded on the NASDAQ and
Tel-Aviv Stock Exchanges (NASDAQ:XTLB)(TASE:XTL). Cautionary
Statement Some of the statements included in this press release,
particularly those anticipating future clinical and business
prospects for our clinical compound for neuropathic pain,
Bicifadine, the likelihood of successful results from a clinical
trial with Bicifadine, operating strategies and similar matters,
may be forward-looking statements that involve a number of risks
and uncertainties. For those statements, we claim the protection of
the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. Among the factors
that could cause our actual results to differ materially are the
following: our ability to obtain positive trial results from the
Phase 2b clinical trial of Bicifadine, raise the funding necessary
for our future operations, and other risk factors identified from
time to time in our reports filed with the Securities and Exchange
Commission, including our annual report on Form 20-F filed with the
Securities and Exchange Commission on March 27, 2008. Any
forward-looking statements set forth in this press release speak
only as of the date of this press release. We do not intend to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release
and prior releases are available at http://www.xtlbio.com/. The
information in our website is not incorporated by reference into
this press release and is included as an inactive textual reference
only. DATASOURCE: XTL Biopharmaceuticals Ltd. CONTACT: Ron Bentsur,
Chief Executive Officer of XTL Biopharmaceuticals Ltd.,
+1-845-267-0707 ext. 225
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