RAANANA, Israel, March 21, 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 it has
completed the clinical trial design for its upcoming Phase 2 study
of hCDR1 in the treatment of systemic lupus erythematosus (SLE).
The global study is planned to commence in 2016, following the
Company's investigational new drug (IND) filing with the U.S. Food
and Drug Administration (FDA).
The study, developed in consultation with XTL's Clinical
Advisory Board, is based on encouraging feedback received from the
FDA in response to the Company's pre-IND meeting package.
The planned global Phase 2 trial is a double-blind, placebo
controlled 26 week study to evaluate the safety and efficacy of
hCDR1 in the treatment of SLE. The study will include three arms.
Two arms will treat subjects with a different hCDR1 weekly dose,
one of which will be the 0.5 mg dose which was the most effective
dose tested in the previous Phase 2 study, and the third arm will
be placebo. The primary efficacy endpoint of the study will be the
proportion of subjects achieving a favorable response at 26 weeks
in at least one organ system. BILAG is a standard diagnostic
measure of the severity of lupus in organ systems and the
recommended measure for efficacy for our trial by the FDA. Data
from a prior Phase 2 study clearly showed a statistically
significant effect of a 0.5 mg dose of hCDR1 on the BILAG
index.
Secondary endpoints include proportions of patients achieving a
substantial response by BILAG 2004, proportion of patients
achieving a response by SLEDAI-2K Responder Index 50, and
additional endpoints presented and accepted by the FDA. Steroid
dosing of subjects will be restricted to improve patient outcomes.
Prior studies showed that reduced steroid usage corresponded with
improved efficacy in patients treated with hCDR1.
"We worked closely with the world-renowned lupus experts on our
Clinical Advisory Board to develop this study design based on the
BILAG index as a measure of hCDR1's efficacy. The FDA's recent
guidance indicating that BILAG is an appropriate efficacy endpoint
for our trial was a very significant and positive milestone. It
enabled us to optimize our study design, and in our opinion,
improves the likelihood of the study's success based on the
efficacy results of the prior Phase 2 trial when a 0.5 mg dose of
hCDR1 was used with the BILAG index," said Josh Levine, CEO of XTL. "We look forward to
filing our IND in the U.S. and commencing the trial this year."
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 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
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. Based on encouraging safety and
efficacy data shown in a completed Phase 2 study, the Company
expects to initiate a Phase 2 trial in 2016.
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. Please see the risk
factors associated with an investment in our ADSs or ordinary
shares which are included in our Registration Statement on Form F-1
as filed with the U.S. Securities and Exchange Commission on
December 31, 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