HERZLIYA, Israel, January 8, 2014 /PRNewswire/ --
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB) (TASE: XTL) ("XTL" or
the "Company"), a clinical-stage biopharmaceutical company focused
on the acquisition, development and commercialization of
pharmaceutical products for the treatment of unmet clinical needs,
today announced it has signed a licensing agreement with Yeda
Research and Development Company Ltd. ("Yeda") to develop hCDR1, a
Phase II-ready asset for the treatment of Systemic Lupus
Erythematosus (SLE).
"Lupus is a debilitating disease affecting approximately five
million people worldwide and represents a tremendous unmet medical
need. In fact, only one new treatment, Benlysta, has been approved
in the last 50 years," stated Josh
Levine, Chief Executive Officer of XTL.
hCDR1, a peptide developed by Prof. Edna
Mozes of the Department of Immunology, The Weizmann
Institute of Science, acts as a disease-specific treatment to
modify the SLE-related autoimmune process by specific upstream
immunomodulation through the generation of regulatory T cells,
reducing inflammation and resuming immune balance. More than 40
peer-reviewed papers have been published on hCDR1.
Two placebo controlled Phase I trials and a placebo controlled
Phase II trial (PRELUDE) were conducted by Teva Pharmaceutical
Industries ("Teva"), which had previously in-licensed hCDR1 from
Yeda. The Phase I and Phase II studies consisted of over 400
patients, demonstrating that hCDR1 is well tolerated by patients
and has a favorable safety profile. The PRELUDE trial did not
achieve its primary efficacy endpoint based on the SLEDAI scale,
resulting in Teva returning the asset to Yeda. However, the
PRELUDE trial showed encouraging results in its secondary clinical
endpoint, the BILAG index, and, in fact, the 0.5 mg weekly dose
showed a substantial effect. Multiple post-hoc analyses also showed
impressive results for this dose using the BILAG index. Such dose
will be the focus of the clinical development plan moving
forward.
The FDA has since directed that the primary endpoint in future
trials for Lupus therapies, including those for hCDR1, should be
based on either the BILAG index or the SLE Responder Index (SRI).
Given the FDA's recommendation and the positive findings from the
PRELUDE trial, XTL intends to initiate a new Phase II clinical
trial, which will include the 0.5 mg (and a 0.25 mg) weekly dose of
hCDR1.
Mr. Levine concluded, "We believe we have a greater likelihood
to successfully develop hCDR1 given the knowledge we have gained
from the PRELUDE trial as well as outcomes related to previous
clinical trials for other Lupus therapies, including
Benlysta. As we take these lessons into consideration, we
expect to further develop and advance hCDR1 towards potential
commercialization."
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.
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 focused on late stage clinical development of drugs for the
treatment of multiple myeloma, schizophrenia and Lupus.
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 Bluetech-50.
Cautionary Statement
Some of the statements included in this Form 6-K may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995.
Contact:
KCSA Strategic Communication
Jeffrey Goldberger / Garth Russell
+1-212-896-1249 / +1-212-896-1250
XTLB@kcsa.com
SOURCE XTL Biopharmaceuticals Ltd