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XTL Biopharm Ltd (XTL)

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Monday 10 September, 2007

XTL Biopharm Ltd

Initiates Ph IIb Trial of Bicifadine for Diab N...


XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine 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                               

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.


                                                                                                    

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