UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For
June
30, 2008
Commission
File Number: 000-51310
XTL
Biopharmaceuticals Ltd.
(Translation
of registrant's name into English)
711
Executive Blvd., Suite Q
Valley
Cottage, New York 10989
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F.
Form
20-F
x Form
40-F
o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1): o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7): o
Indicate
by check mark whether by furnishing the information contained in this Form,
the
registrant is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o No
x
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
N/A
Incorporation
by Reference: This Form 6-K of XTL Biopharmaceuticals Ltd. dated June 30, 2008
is hereby incorporated by reference into the registration statements on Form
F-3
(File No. 333-141529 and File No. 333-147024) filed by XTL Biopharmaceuticals
Ltd. with the Securities and Exchange Commission on March 23, 2007 and October
30, 2007, respectively, and
the registration statements on Form S-8 (File No. 333-148058 and File No.
333-148574) filed by XTL Biopharmaceuticals Ltd. with the Securities and
Exchange Commission on December 14, 2007 and January 18, 2008,
respectively.
XTL
Biopharmaceuticals Announces Completion of Patient Randomization into the
Bicifadine Phase 2b Clinical Trial for the Treatment of Diabetic Neuropathic
Pain
Valley
Cottage, New York, June 30, 2008 -
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®, 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).
Contact:
Ron
Bentsur, Chief Executive Officer
Tel:
+1-(845)-267-0707 ext. 225
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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
| XTL BIOPHARMACEUTICALS LTD. | ||
| |
|
|
| Date: June 30, 2008 | By: | /s/ Ron Bentsur |
|
Ron Bentsur |
||
|
Chief
Executive Officer
|
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