RAANANA, Israel, February 13, 2017 /PRNewswire/ --
- Dr. Robert I. Fox
and Professor Simon
Bowman are world-renowned rheumatologists
and experts in Sjogren's syndrome
- XTL Biopharmaceuticals Ltd., is
a clinical-stage biotech company focused on the
development of pharmaceutical products for the treatment of
autoimmune diseases.
- Sjogren's is a substantial unmet medical need
in an estimated 4
million U.S. patients and
significantly expands market opportunity for XTL's lead drug
candidate
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE:
XTLB.TA) ("XTL" or the "Company"), a clinical-stage
biopharmaceutical company developing treatments for autoimmune
diseases, today announced that two leading experts in rheumatology,
Robert Fox, MD and Simon Bowman, MD, have joined the Company's
clinical advisory board to help guide a planned Phase II trial to
evaluate the company's investigational drug, hCDR1, for the
treatment of Sjögren's syndrome (SS).
Drs. Fox and Bowman join a distinguished group of leading
rheumatologists on the company's advisory board, including
Murray Urowitz, MD, David Isenberg, MD, Dan
Wallace, MD and Lee S. Simon
MD, FACP, FACR.
"Dr. Fox and Professor Bowman are internationally-recognized
experts at the forefront of research in Sjögren's syndrome," said
Josh Levine, CEO of XTL. "Together,
they have more than 30 years of experience in the development of
treatment measures for the SS. We are excited to welcome these
clinicians aboard our already impressive clinical advisory board,
and look forward to benefiting from their experience in trial
design, dosing and other aspects of the drug development process
for our Phase II trial."
Dr. Robert Fox, Chief of the
Rheumatology Clinic at the Scripps-Ximed Medical Group at Scripps
Memorial Hospital in La Jolla, CA,
specializes in the pathogenesis and treatment of Sjögren's
syndrome. He has been involved in studies of therapies to
treat Sjögren's syndrome for more than 15 years, including writing
clinical protocols for pivotal trials. He has edited a number of
journals and pursued research as a principal investigator in
multicenter clinical trials and his own NIH-funded research
programs. Additionally, Dr. Fox serves as a member of the American
College of Rheumatology's Advisory Board for Sjögren's Syndrome as
well as the Advisory Board for the National Sjögren's Syndrome
Foundation. In recent years, he has served as Rheumatology Editor
for Medscape and written more than 100 articles and editorials for
practicing physicians and patients.
"Sjögren's syndrome is a very difficult disease to overcome and
has a severe impact on the patients' quality of life and function,"
said Dr. Fox. "New treatment options are urgently needed, and I am
looking forward to working with XTL to evaluate the clinical impact
of hCDR1 for treating the systemic manifestations of the disease."
Professor Simon Bowman has been a
consultant rheumatologist for over 15 years at the Queen Elizabeth
Hospital in Birmingham. He is a Fellow at the Royal College of
Physicians; a past President of the British Sjögren's Syndrome
Association, member of the Sjögren's Syndrome Foundation of America
and past President of the British Society for Rheumatology.
Professor Bowman has broad experience in all areas of
rheumatology, with a particular clinical and research interest in
Sjögren's syndrome. He holds an Honorary Chair at the
University of Birmingham and has
published widely on the topic of Sjögren's syndrome and other
connective tissue disorders.
"I am pleased to support XTL'S clinical development program for
hCDR1 for the treatment of Sjögren's syndrome," said Professor
Bowman. "This investigational agent's therapeutic potential is
supported by the results of the PRELUDE study for lupus, a similar
autoimmune condition, where the agent had positive systemic effect,
as well as recent pre-clinical studies that show a reduction in
gene expression in three cytokines considered to be pathogenic in
the disease."
About Sjögren's syndrome
Sjögren's syndrome is a systemic autoimmune disease with some
autoantibodies and clinical manifestations similar to those
detected in SLE. Although many patients experience dry
eyes, dry mouth ,fatigue and joint pain, Sjögren's
syndrome also causes dysfunction of organs such as the kidneys,
gastrointestinal system, blood vessels, lungs, liver, pancreas, and
the central nervous system. Patients also have a substantially
higher risk of developing lymphoma. Today, as many as four million
Americans are living with this disease, according to the Sjögren's
Syndrome Foundation.
Current standard of care in the U.S. includes treating specific
symptoms such as dry eyes, dry mouth, and arthritis. Systemic
manifestations are often treated with drugs used to treat other
autoimmune diseases, such as hydroxychloroquine, methotrexate, or
azathioprine. However, these treatments are not sufficient in many
patients and may have significant side effects. There is no
approved specific drug for the treatment of systemic manifestations
in Sjögren's syndrome.
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and
clinical data on over 400 patients in three clinical studies. The
drug has a favorable safety profile, is well tolerated by patients
and has demonstrated efficacy in at least one clinically meaningful
endpoint. For more information please see a peer reviewed article
in Lupus Science and Medicine journal (full article).
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd., is a clinical-stage biotech
company focused on the development of pharmaceutical products for
the treatment of autoimmune diseases. The Company's lead drug
candidate, hCDR1, is a world-class clinical asset for the treatment
of autoimmune diseases including systemic lupus erythematosus (SLE)
and Sjögren's Syndrome (SS). The few treatments currently on the
market for these diseases are not effective enough for most
patients and some have significant side effects. hCDR1 has robust
clinical data in three clinical trials with 400 patients and over
200 preclinical studies with data published in more than 40
peer reviewed scientific journals.
XTL is traded on the Nasdaq Capital Market (NASDAQ: XTLB)
and the Tel Aviv Stock Exchange (TASE: XTLB.TA). XTL shares are
included in the following indices: Tel-Aviv Biomed, Tel-Aviv
MidCap, and Tel-Aviv Tech Index.
Cautionary Statement
This press release may contain forward-looking statements, about
XTL's expectations, beliefs or intentions regarding, among other
things, its product development efforts, business, financial
condition, results of operations, strategies or prospects. In
addition, from time to time, XTL or its representatives have made
or may make forward-looking statements, orally or in writing.
Forward-looking statements can be identified by the use of
forward-looking words such as "believe," "expect," "intend,"
"plan," "may," "should" or "anticipate" or their negatives or other
variations of these words or other comparable words or by the fact
that these statements do not relate strictly to historical or
current matters. These forward-looking statements may be included
in, but are not limited to, various filings made by XTL with the
U.S. Securities and Exchange Commission, press releases or oral
statements made by or with the approval of one of XTL's authorized
executive officers. Forward-looking statements relate to
anticipated or expected events, activities, trends or results as of
the date they are made. Because forward-looking statements relate
to matters that have not yet occurred, these statements are
inherently subject to risks and uncertainties that could cause
XTL's actual results to differ materially from any future results
expressed or implied by the forward-looking statements. Many
factors could cause XTL's actual activities or results to differ
materially from the activities and results anticipated in such
forward-looking statements, including, but not limited to, the
factors summarized in XTL's filings with the SEC and in its
periodic filings with the TASE. In addition, XTL operates in an
industry sector where securities values are highly volatile and may
be influenced by economic and other factors beyond its control.
XTL does not undertake any obligation to publicly update
these forward-looking statements, whether as a result of new
information, future events or otherwise. Please see the risk
factors associated with an investment in our ADSs or ordinary
shares which are included in our Form 20-F filed with the U.S.
Securities and Exchange Commission on March
31, 2016.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals Ltd.
Tel: +44-972-9955-7080
Email: ir@xtlbio.com
http://www.xtlbio.com
Stephanie Carrington
ICR, Inc.
+44-646-277-1282
Stephanie.Carrington@icrinc.com
Media
James Heins
ICR, Inc.
+44-203-682-8251
James.Heins@icrinc.com
SOURCE XTL Biopharmaceuticals Ltd