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
the
month of October 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): ____
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): ____
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 October 7,
2008
is hereby incorporated by reference into the registration statements on Form
F-3
(File No. 333-141529, File No. 333-147024 and File No. 333-153055) filed by
XTL
Biopharmaceuticals Ltd. with the Securities and Exchange Commission on March
23,
2007 , October 30, 2007 and August 15, 2008, 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 the Bicifadine Phase 2b Study for
Diabetic Neuropathic
Pain
Valley
Cottage, New York, October 7, 2008
- XTL
Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: 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®, 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).
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 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.
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: October 7, 2008 | By: | /s/ Bill Kessler |
|
Bill Kessler |
||
| Director of Finance | ||