XTL Biopharmaceuticals Announces Completion of Patient Randomization Into the Bicifadine Phase 2b Clinical Trial for the Treatme
June 30 2008 - 8:35AM
PR Newswire (US)
VALLEY COTTAGE, N.Y., June 30 /PRNewswire-FirstCall/ -- XTL
Biopharmaceuticals Ltd. (NASDAQ:XTLB)(TASE:XTL) today announced
that it has completed patient randomization into its Phase 2b study
of Bicifadine -- a serotonin and norepinephrine reuptake inhibitor
(SNRI) -- for the treatment of diabetic neuropathic pain. 350
patients were randomized into the study. Based on the completion of
randomization, the Company expects to have the last patient
complete the study in the next 4 months. The Phase 2b trial 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 2b 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. Approximately 40 clinical centers in the United
States, Germany, Israel and India are participating in the study.
Following randomization, all patients enter a 2-week titration
period to allow them to gradually escalate up to their target
treatment dose. This is 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). 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 demonstrated in over 15 clinical trials in acute pain, and
its 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. Ron Bentsur, XTL's Chief
Executive Officer, commented, "We are very excited to have
completed this milestone of patient randomization ahead of our
projected timeline, and we remain grateful for the tremendous
dedication of the investigators who are participating in the
study." Mr. Bentsur added, "We eagerly await the outcome of this
study in Q4 2008." XTL in-licensed the world-wide 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 serotonin and norepinephrine
reuptake inhibitor, for the treatment of diabetic neuropathic pain,
which is currently in a Phase 2b study. XTL has out-licensed its
novel pre-clinical HCV small molecule inhibitor program. XTL also
has an active in-licensing and acquisition program designed to
identify and acquire additional drug candidates. 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 successfully complete the Phase 2b clinical trial with
Bicifadine and obtain positive trial results from the Phase 2b
clinical trial, all of which will directly impact our ability to
continue to fund our 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 Web site: http://www.xtlbio.com/
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