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
September 10, 2007
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 September
10,
2007 is hereby incorporated by reference into the registration statement on
Form
F-3 (File No. 333-141529) filed by XTL Biopharmaceuticals Ltd. with the
Securities and Exchange Commission on March 23, 2007.
XTL
Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine
for the Treatment of Diabetic Neuropathic Pain
for the Treatment of Diabetic Neuropathic Pain
Company
to Hold a Conference Call Tomorrow (Tuesday) at 8:30 am EDT to
Discuss the Clinical Trial
Discuss the Clinical Trial
Valley
Cottage, New York, September 10, 2007 -
XTL
Biopharmaceuticals Ltd. (NASDAQ: XTLB; LSE: XTL; TASE: XTL) today announced
the
initiation of a Phase IIb clinical trial of Bicifadine - a serotonin and
norepinephrine reuptake inhibitor (SNRI) - for the treatment of diabetic
neuropathic pain.
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 clearly demonstrated in over 15 clinical
trials in acute pain, and its favorable 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.
The
Phase
IIb trial that was launched today 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
IIb 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. The Phase IIb study is designed to enroll approximately 330
patients. Approximately 45 clinical centers in the United States, Europe and
India will participate in the study. Following randomization, all patients
will
enter a 2-week titration period to allow them to gradually escalate up to their
target treatment dose. This will be 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 will be 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
lead
investigators in the study are Dr. Andrew Boulton, M.D. and Dr. Sherwyn
Schwartz, M.D. Dr. Boulton is Professor of Medicine, Division of Endocrinology,
Diabetes and Metabolism, at the University of Miami and the University of
Manchester, UK. Professor Boulton has been active in clinical research in
diabetic neuropathy over the last 25 years and has published over 250 peer
reviewed articles on the subject. He was co-chair of the committee that
formulated the American Diabetes Association statement on diabetic neuropathy
published in Diabetes Care in 2005. Dr. Schwartz is Chief Executive Officer
and
Chief Medical Officer of DGD Research, Inc. which is the largest diabetes and
endocrinology practice in the United States. Dr. Schwartz has over 20 years
of
clinical research experience in diabetes and diabetic complications, and has
participated in hundreds of clinical trials in the field.
Dr.
Christine Sang, Director of Translational Pain Research at the Brigham and
Women’s Hospital, Harvard Medical School, and Chair of XTL’s Scientific Advisory
Board, commented, “Based on the evidence for the role of SNRI’s in the treatment
of neuropathic pain, I believe that Bicifadine has strong potential to be
successfully developed as a treatment for diabetic neuropathic pain. I am also
encouraged by the drug’s activity observed in previous acute pain studies and
its safety exposure in over 3,000 patients to date.”
Dr.
Andrew Boulton, Co-Lead Investigator in the study, commented, “This study design
is similar to the design of the successful registration trials of duloxetine
(Cymbalta®) in diabetic neuropathic pain and those of other approved agents.
This study is well powered to demonstrate a clinical benefit that is comparable
to the approved agents for this disease. I am happy to be involved in this
important program.”
Dr.
Sherwyn Schwartz, Co-Lead Investigator in the study, commented, “As the head of
the largest diabetes center in the country, I believe that diabetic neuropathic
pain continues to be an area of tremendous unmet medical need, as many patients
do not adequately respond to the limited number of therapies that are available.
I am intrigued by the possibility of having another SNRI with a unique ratio
of
reuptake inhibition of serotonin versus norepinephrine to offer to my patients.”
Ron
Bentsur, XTL’s Chief Executive Officer, commented, “We are very excited to be
initiating this late-stage clinical trial for Bicifadine and are enthusiastic
about the strong support for this trial from many of the top clinical
investigative sites from around the world.”
XTL
in-licensed the world-wide rights to Bicifadine from Dov Pharmaceutical, Inc.
(NASDAQ OTC: DOVP) in January 2007.
CONFERENCE
CALL INFORMATION
XTL
will
hold a conference call tomorrow, Tuesday, September 11, 2007, at 8:30 am EDT
to
discuss Bicifadine and the Phase IIb clinical trial. In order to participate
in
the conference call, please call +1-877-502-9272 (in the United States),
+1-913-981-5581 (outside the United States), call in passcode: 2040477. An
audio
recording of the conference call will be available for replay by calling
+1-888-203-1112 (in the United States), +1-719-457-0820 (outside the United
States), replay passcode 2040477, for a period of 45 days after the
call.
ABOUT
DIABETIC NEUROPATHIC PAIN
Diabetic
neuropathic pain is a chronic pain condition resulting from damage to nerves
in
patients with diabetes. Diabetic neuropathic pain, which manifests itself
primarily in the feet, can often be debilitating thus preventing patients from
carrying out their normal day-to-day activities. In the United States, it is
estimated that 4.5 million patients with diabetes suffer from diabetic
neuropathic pain. Diabetic neuropathic pain is the largest segment in the
rapidly growing market for neuropathic pain drugs. This market was estimated
at
$1.8 billion in 2005, and is expected to grow to $5.5 billion by 2015. Only
two
oral drugs have been approved to date by the FDA for the treatment of diabetic
neuropathic pain (Eli Lilly’s Cymbalta®, an SNRI, and Pfizer’s
Lyrica®);
however, the response rates to these drugs are limited. Consequently, millions
of patients remain without adequate treatment options and seek new drugs that
could provide better relief for their chronic pain.
ABOUT
THE SNRI DRUG CLASS
Serotonin
and Norepinephrine Reuptake Inhibitors (SNRI’s) are drugs that increase the
levels of serotonin and norepinephrine in the brain, thus blocking pain signals.
SNRI is a proven drug class in diabetic neuropathic pain as well as Major
Depressive Disorder. One SNRI (Eli Lilly’s Cymbalta®) is already approved for
the treatment of diabetic neuropathic pain, while a second SNRI (Wyeth’s
Effexor®) has demonstrated efficacy in treatment of diabetic neuropathic pain in
large, randomized and placebo-controlled studies. Both Cymbalta® and Effexor®
are also approved for depression. A third SNRI (Cypress’ Milnacipran®) recently
demonstrated efficacy in a Phase III trial in a related neuropathic pain
indication (fibromyalgia), providing further evidence of the efficacy of the
SNRI class in neuropathic pain.
ABOUT
BICIFADINE
Bicifadine
is an SNRI which is presently being developed for the treatment of diabetic
neuropathic pain. As a member of the proven SNRI class, Bicifadine is expected
to demonstrate efficacy in the treatment of diabetic neuropathic pain.
Bicifadine has already demonstrated its efficacy as an analgesic in 15 clinical
trials in patients suffering from acute pain, including in two large,
randomized, placebo-controlled Phase III trials. In addition, Bicifadine has
already demonstrated a favourable safety profile, having been evaluated in
more
than 3,000 patients.
Bicifadine
is different from other approved members of the SNRI class in its unique ratio
of inhibition reuptake of serotonin versus norepinephrine (which is weighted
towards norepinephrine reuptake inhibition). This unique ratio is expected
to
translate into a unique response profile of patients to Bicifadine.
As
the
treatment paradigm in neuropathic pain involves switching patients among drugs
(both within the same drug class, as well as among drug classes), in order
to
find the specific drug to which the patient responds best, Bicifadine is
expected to offer a unique alternative to patients who do not adequately respond
to the currently approved drugs. Furthermore, if clinical trials demonstrate
that Bicifadine has an advantage over the currently approved drugs in either
overall efficacy rates, safety profile, or onset of action, it has the potential
to become a first-line treatment for diabetic neuropathic pain.
ABOUT
XTL BIOPHARMACEUTICALS LTD.
XTL
Biopharmaceuticals Ltd. (“XTL”) is engaged in the development of therapeutics
for the treatment of neuropathic pain and hepatitis C. XTL is developing
Bicifadine, a serotonin and norepinephrine reuptake inhibitor, for the treatment
of diabetic neuropathic pain. XTL is also developing several novel pre-clinical
hepatitis C small molecule inhibitors. 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, London, and Tel-Aviv Stock
Exchanges (NASDAQ: XTLB; LSE: XTL; 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 launch a Phase IIb clinical trial
with Bicifadine, recruit adequate participants for such a Phase IIb clinical
trial, obtain positive trial results from a Phase IIb clinical trial, and our
ability to successfully complete cost-effective pre-clinical trials for our
DOS
program, all of which will directly impact our ability to continue to fund
our
operations; our ability to meet anticipated development timelines for all of
our
drug candidates due to recruitment, clinical trial results, manufacturing
capabilities or other factors; and other risk factors identified from time
to
time in our reports filed with the Securities and Exchange Commission and the
London Stock Exchange, including our annual report on Form 20-F filed with
the
Securities and Exchange Commission on March 23, 2007. 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: September 10, 2007 | By: | /s/ Bill Kessler |
|
Bill Kessler |
||
|
Director
of Finance
|
||