UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of September, 2017
Commission File Number:
001-36000
XTL Biopharmaceuticals Ltd.
(Translation of registrant’s name
into English)
5 HaCharoshet St., Raanana,
____________
4365603, Israel
____________
(Address of principal executive offices)
Indicate by check mark whether the registrant
files or will file annual reports under cover Form 20-F or Form 40-F.
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Incorporation by Reference: This Form
6-K of XTL Biopharmaceuticals Ltd. is hereby incorporated by reference into the registration statements on Form S-8 (File No. 333-148085,
File No. 333-148754 and File No. 333-154795) and Form F-3 (File No. 333-194338).
xtl
biopharmaceuticals Unveils ADDITIONAL
expanded hcdr1 preclinical data for the
treatment of sjogren’s syndrome
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Additional data shows a statistically
significant effect in the gene expression of an additional gene that has a role in the pathogenesis of Sjögren’s syndrome
(SS)
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Substantial unmet medical need in
estimated four million U.S. patients
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Filed patent covers the effect of
hCRD1 on such gene expression with implications for the treatment of SS
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HERTZLIYA,
Israel
- (September 12, 2017) –
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 Company has filed a third patent application with the U.S. Patent and Trademark Office for hCDR1
in the treatment of SS.
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 two immunosuppressive
genes, one of which is a marker for activity of regulatory T cells
.
The vast majority of 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.
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 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
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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-A filed with the U.S. Securities
and Exchange Commission on April 3, 2017.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act
of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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XTL BIOPHARMACEUTICALS LTD.
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Date: September 12, 2017
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By:
/s/ Josh Levine
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Josh Levine
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Chief Executive Officer
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