XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of Diabetic Neuropathic Pain
September 10 2007 - 2:57AM
PR Newswire (US)
Company to Hold a Conference Call Tomorrow (Tuesday) at 8:30 am EDT
to Discuss the Clinical Trial Valley Cottage, NEW YORK, September
10 /PRNewswire-FirstCall/ -- 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(R), 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(R)) 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(R), an SNRI, and Pfizer's Lyrica(R)); 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(R)) is
already approved for the treatment of diabetic neuropathic pain,
while a second SNRI (Wyeth's Effexor(R)) has demonstrated efficacy
in treatment of diabetic neuropathic pain in large, randomized and
placebo-controlled studies. Both Cymbalta(R) and Effexor(R) are
also approved for depression. A third SNRI (Cypress'
Milnacipran(R)) 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).
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. Contact: Ron Bentsur Chief Executive Officer Tel:
+1-(845)-267-0707 ext. 225 DATASOURCE: XTL Biopharmaceuticals Ltd
CONTACT: Contact: Ron Bentsur, Chief Executive Officer, Tel:
+1-(845)-267-0707 ext. 225
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