RAANANA, Israel, April 5, 2017 /PRNewswire/ --
- Additional data shows a
statistically significant effect
in the gene expression of
two additional genes that
have a role in the pathogenesis of
Sjögren's
syndrome (SS)
- Substantial unmet medical need in estimated
four million U.S. patients
- Filed patent covers the
effect of hCRD1 on
such gene expression with implications
for the treatment of SS
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 has received additional preclinical data regarding the role
of hCDR1 as a potential treatment for Sjögren's syndrome (SS) from
Prof. Edna Mozes of The Weizmann
Institute of Science and the developer of hCDR1.
The expansion of these in-vitro data
includes peripheral blood mononuclear cells (PBMC) obtained from
additional blood samples from patients with primary SS. The data to
date show that incubation with hCDR1 results in a statistically
significant reduction in the gene expression of four pathogenic
cytokines known to be involved in SS and lupus (including
B-lymphocyte stimulator or BLyS), as well as upregulation of an
immunosuppressive gene and a marker for activity of regulatory T
cells. Such effects were previously seen in similar studies
involving lupus patients. Concurrently, hCDR1 is in development for
the treatment of systemic lupus erythematosus (SLE), has been
tested in over 400 patients, and is ready to enter a global Phase 2
trial for SLE.
"We are pleased by the results of this extension study, which
reinforce the potential of hCDR1 to provide patients with Sjögren's
syndrome with the first-ever approved therapy to treat the systemic
manifestations of the disease," said Josh
Levine, CEO of XTL. "Given Sjögren's syndrome and systemic
lupus erythematosus may have similar but distinct disease
manifestations, these data further support the positive results of
our prior Phase 2 study of hCDR1 in treating SLE. Both SLE/lupus
and SS have large unmet clinical needs, with few satisfactory
treatment options and both indications have seen recent failures in
clinical studies with the notable exception of the recent
successful Phase 2 in Lupus Nephritis of Voclosporin being
developed by Aurinia Pharmaceuticals."
Based on hCDR1's well-known mechanism of action and favorable
safety profile, XTL plans to pursue an accelerated clinical
development path for the treatment of SS. Additionally, a second
patent application has been filed with the U.S. Patent and
Trademark Office for hCDR1 in the treatment of SS.
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 may also cause
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 many
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 April
3, 2017.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals Ltd.
Tel: +972-9-955-7080
Email: ir@xtlbio.com
http://www.xtlbio.com
SOURCE XTL Biopharmaceuticals Ltd
