RAANANA, Israel, August 11, 2016 /PRNewswire/ --
XTL Biopharmaceuticals Ltd.
(NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a
clinical-stage biopharmaceutical company developing its lead
product for the treatment of lupus, today announced that it has
filed a new patent application with the U.S. Patent and Trademark
Office to protect doses of hCDR1 lower than 0.5 mg weekly, in the
treatment of Systemic Lupus Erythematosus (SLE).
The new patent application is based on clinical evidence that
lower doses of hCDR1 may be as efficient, or in some instances more
efficient, than the higher doses previously tested in the treatment
of SLE. Lower doses of hCDR1 may improve clinical outcomes in SLE
patients when used as a standalone treatment, or when used as a
combination therapy in addition to standard of care. Improved
outcomes may include the potential to control disease activity in
patients who do or do not require steroids. For patients who do
require steroids, an hCDR1 combination therapy may decrease the
dosage of steroids required to control disease activity.
"We are pleased to expand the intellectual property assets
around hCDR1, based on clinical data showing hCDR1 may be effective
at doses lower than the 0.5 mg weekly, which has shown
statistically significant efficacy as compared to placebo in a
prior Phase 2 study," said Josh
Levine, CEO of XTL. "While, as a new chemical entity, hCDR1
already will be entitled to data exclusivity, this patent
application adds to a robust and growing portfolio of applications
and issued patents in key markets around the world."
XTL completed its Phase 2 clinical trial design for hCDR1 in the
treatment of SLE earlier this year. The trial design includes a
treatment arm dosing weekly at 0.5 mg hCDR1 and BILAG as the
measure for the primary efficacy endpoint. Data from the prior
Phase 2 study clearly showed a statistically significant effect of
a 0.5 mg dose of hCDR1 on the BILAG index.
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and
has 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 Systemic Lupus Erythematosus (SLE)
Lupus is a chronic inflammatory 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 dysregulation of 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 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., is a clinical-stage biotech
company focused on the development of pharmaceutical products for
the treatment of autoimmune diseases including lupus. The Company's
lead drug candidate, hCDR1, is a world-class clinical asset for the
treatment of systemic lupus erythematosus (SLE). Treatments
currently on the market for SLE 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.
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, except as may be required
under applicable securities laws. 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 March 31,
2016.
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