RAANANA, Israel, January 11, 2016 /PRNewswire/ --
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE:
XTL) ("XTL" or the "Company"), a clinical-stage
biopharmaceutical company developing its lead product for the
treatment of lupus, today announced that it has submitted the full
protocol for its advanced stage clinical trial of hCDR1 for the
treatment of systemic lupus erythematosus (SLE) to Yeda Research
and Development Company Ltd. (Yeda).
XTL previously announced that it has submitted a Pre-IND meeting
package to the US Food and Drug Administration and expects to
receive written responses regarding its proposed clinical study in
the coming weeks. A Phase 2b clinical trial of hCDR1 was previously
completed and the compound has shown a favorable safety profile in
over 400 patients and efficacy in at least one clinically relevant
endpoint.
Submission of this clinical trial protocol marks a milestone for
XTL in its development of hCDR1, which the Company is developing
under license from Yeda, the technology transfer arm of the
world-renowned Weizmann Institute of Science.
Josh Levine, Chief Executive
Officer of XTL, commented, "We are pleased to have met this
important milestone and to continue our partnership with Yeda in
the development of this novel drug for the benefit of lupus
patients. We are making good progress in all of our regulatory,
clinical and chemistry, manufacturing and control (CMC) activities
and expect to meet the remaining development milestones."
Amir Naiberg, Chief Executive
Officer of Yeda, added, "We are encouraged by the progress that XTL
has made to date with hCDR1 and we look forward to XTL's continued
development of the drug for the treatment of SLE."
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and
with clinical data on over 400 patients in 3 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 Systemic Lupus Erythematosus (SLE)
Lupus is a chronic autoimmune disease involving many systems in
the human body, including joints, kidneys, central nervous system,
heart, hematological system and others. The biologic basis of the
disease is a defect in the immune (defense) system, leading to
production of self (auto) antibodies, attacking the normal organs
and causing irreversible damage. According to the Lupus Foundation
of America, at least 1.5 million Americans have the disease (more
than 5 million worldwide) with more than 16,000 new cases diagnosed
each year. The majority of patients are women of childbearing
years. There has been only one drug approved by the FDA in the last
over 50 years and recently two of the few drugs in advanced
development did not meet their primary endpoints in Phase 3
trials.
About Yeda Research and Development
Company
Yeda Research and Development Company Ltd. is the commercial arm
of the Weizmann Institute of Science, one of the world's leading
multidisciplinary research institutions.
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd., a biopharmaceutical company,
focuses on the acquisition, development, and commercialization of
pharmaceutical products for the treatment of unmet clinical needs
with a focus on treatments for autoimmune diseases.
XTL is a public company, traded on the Nasdaq Capital Market
(NASDAQ: XTLB) and the Tel Aviv Stock Exchange (TASE: XTL). 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 Annual Report on Form 20-F as
filed with the U.S. Securities and Exchange Commission on
April 28 2015.
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