RAANANA, Israel, August 26, 2015 /PRNewswire/ --
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTL)
("XTL" or the "Company"), announced today that previously reported results of a Phase 2b study on
the safety and efficacy of its lead drug candidate, hCDR1
(Edratide) for the treatment of SLE (lupus) were published in the
Lupus Science & Medicine Journal. See link for full article
(full article).
The article, authored by leading rheumatologists, Dr.
Murray Urowitz, Dr. David Isenberg and Dr. Dan Wallace, reported the results of a study
conducted by Teva Pharmaceuticals in which Edratide demonstrated
efficacy in one and possibly more clinically meaningful endpoints.
According to the article, dose ranging studies demonstrated that
the 0.5mg dose administered weekly as a subcutaneous injection was
the most effective dose and that the drug showed no safety signals
in the 26 week study.
Further the article stated that the study (PRELUDE) showed that
Edratide was safe and well tolerated and while the primary
endpoints based solely on SLEDAI-2K and AMS were not met, the
secondary predefined endpoint, BILAG, was met for the 0.5 mg
Edratide arm in the intention to treat (ITT) cohort (N=316)
(OR=2.09, p=0.03) with trends in the 1.0 and 2.5 mg doses. The
article also stated that there was a positive trend in the
Composite SLE Responder Index of the ITT cohort and post hoc
analysis showed that the BILAG secondary endpoint was also met for
the 0.5 mg Edratide for a number of subgroup dose levels, including
low or no steroids, seropositivity and patients with 2 grade BILAG
improvement.
The article concluded that the favorable safety profile and
encouraging clinically significant effects noted in some of the
endpoints support the need for additional longer term Edratide
studies that incorporate recent advances in the understanding and
treatment of SLE, including steroid treatment algorithms, and using
a composite primary endpoint which is likely to include BILAG.
Josh Levine, Chief Executive
Officer of XTL, commented, "The encouraging data published in a
peer-reviewed article in Lupus Science & Medicine regarding
Edratide, our lead drug candidate for the treatment of SLE, further
strengthens XTL's resolve to bring this drug candidate to market as
soon as possible. With the recent announcements of drugs
being developed for the treatment of lupus by UCB and Eli Lilly
failing to reach their primary endpoints in Phase 3 trials, there
remains a significant unmet medical need in SLE."
"We believe that there is a substantial opportunity for our lead
drug candidate, hCDR1 (Edratide). We look forward to continuing the
development of Edratide in advanced clinical trials and providing a
measure of hope to patients suffering from this disease and the
clinicians who treat them. We will continue to share our progress
with you in the coming months."
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.
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