RAANANA, Israel, October 13, 2015 /PRNewswire/ --
XTL Biopharmaceuticals Ltd. (NASDAQ:
XTLB, TASE: XTL) ("XTL" or the "Company"), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of pharmaceutical products for the treatment of
unmet clinical needs with a focus on treatments for autoimmune
diseases, today announced that it has reached agreement with Yeda
Research and Development Company Ltd. ("Yeda") to amend the
development milestones in the License Agreement signed between the
parties in January 2014 for the
development of hCDR1 for the treatment of systemic lupus
erythematosus (SLE).
The amended agreement extends the time for achievement of key
development milestones by approximately five additional months
including delivery to Yeda of a full protocol for an upcoming
clinical trial on hCDR1, raising an aggregate of US$5 million (of which US$4 million was raised in April 2015), and commencing a clinical trial on
hCDR1 by January 2017.
Josh Levine, Chief Executive
Officer of XTL, commented, "We are pleased with Yeda's affirmation
of their support and confidence in our ability to develop hCDR1 for
the treatment of SLE. The amended agreement recognizes XTL's
efforts to date to advance hCDR1 to a clinical trial including:
assembling a world-class Clinical Advisory Board with leading names
in SLE, strengthening the Company's Board with Directors with drug
development and financial market experience, transferring the IND
relating to hCDR1 from Teva Pharmaceutical Industries Limited to
the Company, manufacturing the drug substance for the upcoming
trial, engaging in ongoing discussions with the FDA to seek
opportunities to strengthen hCDR1 intellectual property and
optimize the regulatory pathway, and raising US $4 million out of the aggregate amount of US
$5 million as required by the License
Agreement."
"We believe the amended agreement provides XTL with the time
needed to properly develop our hCDR1 program and bring the product
to an advanced clinical trial in the near future. We believe our
operational plan and activities over the last several months should
allow us to achieve the amended development milestones well within
the revised timeline. The recent publication of the encouraging
results of a previous Phase 2b trial (the PRELUDE trial) on hCDR1
in a peer reviewed article in the Lupus Science and Medicine
journal (full article), showing favorable safety and efficacy data
on over 300 patients, further strengthens our commitment to advance
the development of hCDR1 as soon as possible."
Amir Naiberg, Chief Executive
Officer of Yeda commented: "We are encouraged by the progress that
XTL has made to date with hCDR1. We look forward to XTL's continued
development of the drug for the treatment of SLE."
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 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
Arrowhead Business and Investment Decisions, LLC
140 Broadway, 46th Floor, New York,
NY 10005
Daniel Renaud or Thomas Renaud
+1-212-619-6889
enquire@arrowheadbid.com
http://www.abid.co/NASDAQ.XTLB
SOURCE XTL Biopharmaceuticals Ltd