RAANANA, Israel, January 25, 2016 /PRNewswire/ --
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE:
XTLB) ("XTL" or the "Company"), a clinical-stage
biopharmaceutical company developing its lead product for the
treatment of lupus, today announced the Company has received
written guidance from the U.S. Food and Drug Administration (FDA)
in response to a pre-investigational new drug (IND) meeting package
regarding its upcoming IND filing for its drug candidate, hCDR1.
Based on the FDA's response, XTL plans to file its IND, and in the
coming quarters initiate a global clinical trial for hCDR1 in the
treatment of systemic lupus erythematosus (SLE) in the U.S.,
Europe and Israel.
The FDA provided encouraging guidance on several key aspects of
XTL's proposed clinical trial including: the primary efficacy
endpoint to be based on the BILAG index, a measure of lupus disease
activity which was the secondary efficacy endpoint in a prior Phase
2 study of hCDR1; the appropriate patient population; and total
number of patients required to prove safety for a new drug
application (NDA) for marketing approval. The FDA recommended that
the trial be a Phase 2 study. The FDA has also provided additional
guidance on other aspects of the trial design, which XTL intends to
review with its Clinical Advisory Board as it finalizes the study
protocol including doses and study duration.
"We are very pleased with the FDA's written response to our
pre-IND filing meeting package and see it as a vote of confidence
in our ability to bring a much needed treatment to people living
with lupus," stated Josh Levine,
Chief Executive Officer of XTL.
"This study has an increased likelihood to succeed, in our view,
because the FDA's guidance encourages the study to be substantially
similar to the prior Phase 2 trial which demonstrated efficacy in
the 0.5 mg dose using the BILAG index, the secondary endpoint of
that trial. We believe the FDA's guidance validates the value and
relevance of the safety and efficacy data from the prior Phase 2
trial including data on the patient population and statistically
significant effect of a 0.5mg dose of hCDR1 on the BILAG endpoint.
Using a primary efficacy endpoint based on the BILAG index, we are
hopeful that our upcoming study will produce robust data towards
supporting a future NDA filing," 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 and possibly more
clinically meaningful endpoints. 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 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). There currently is
no effective treatment on the market for SLE. 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 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). 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