RAANANA, Israel, January 13, 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 reached agreement with CyDex
Pharmaceuticals Inc. (La Jolla,
CA) (CyDex) for the use and supply of Captisol® in
the formulation of its lead drug, hCDR1, for the treatment of
systemic lupus erythematosus (SLE).
The agreement grants XTL a non-exclusive, royalty-free license
to use Captisol® in the formulation of its drug for the
purpose of conducting its advanced clinical study on hCDR1 for the
treatment of SLE subject to the payment of certain milestone and
other payments.
Josh Levine, Chief Executive
Officer of XTL, commented, "We are pleased with the completion of
this strategic agreement with CyDex for the use and supply of
Captisol®. This partnership represents a key element of our
preparations for the advanced clinical study of hCDR1 and together
with our agreement with BioConnection NV for the production of our
drug product, we believe this will advance much of the chemistry
manufacturing and control activities required prior to IND
approval."
"With our progress on the production of the drug product and an
FDA response to our proposed study design expected in early 2016,
we are positioning ourselves to initiate the trial in the second
half of 2016. We believe that hCDR1 has the potential to be a
'first in class' and 'best in class' drug in an area with a
significant unmet medical need. There is currently no
effective solution for SLE in the market and the competitive
pipeline is remarkably weak," Levine added.
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 further 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 Captisol®
Captisol® is a patent protected, uniquely modified cyclodextrin,
whose chemical structure was rationally designed to enable the
creation of new products by significantly improving solubility,
stability, bioavailability and dosing of active pharmaceutical
ingredients (APIs).
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