RAANANA, Israel, Jan. 5,
2017 /PRNewswire/ -- XTL Biopharmaceuticals
Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the
"Company"), a clinical-stage biopharmaceutical company developing
treatments for autoimmune diseases, today announced the Company
intends to pursue Sjögren's syndrome as the second indication for
its lead drug candidate hCDR1. Currently in development for the
treatment of systemic lupus erythematosus (SLE), hCDR1 has been
tested in over 400 patients, and is set to enter a global Phase 2
trial for SLE.
New in-vitro data from studies evaluating cells obtained
from serum samples of patients with Sjögren's syndrome demonstrate
that incubation with hCDR1 resulted in a significant reduction of
gene expression of three cytokines considered to be pathogenic in
Sjögren's syndrome. These data correspond to some of the in
vitro data obtained in studies testing serum samples from
patients with SLE.
Josh Levine, CEO of XTL, stated,
"Sjögren's syndrome impacts more than twice the number of people as
SLE does in the U.S. and represents a significant unmet therapeutic
need. While there are currently only a handful of drugs in clinical
trials to treat Sjögren's syndrome, there is no specific FDA
approved therapy to treat the systemic manifestations of the
disease. Given the similarities of the disease manifestations
between Sjögren's syndrome and SLE, these new in-vitro data
further support the clinical results achieved in the prior Phase 2
trial of hCDR1 in SLE. Based on hCDR1's well established mechanism
of action and its favorable safety profile in over 400 patients, we
plan to pursue an accelerated clinical development path with hCDR1
for this new indication."
A patent application has been filed with the U.S. Patent and
Trademark Office for hCDR1 in the treatment of Sjögren's
syndrome.
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.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals Ltd.
Tel:
+972 9 955 7080
Email: ir@xtlbio.com
www.xtlbio.com
Stephanie Carrington
ICR, Inc.
+1-646-277-1282
Stephanie.Carrington@icrinc.com
Media
James Heins
ICR, Inc.
+1-203-682-8251
James.Heins@icrinc.com
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.
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