XTL Biopharmaceuticals In-licenses hCDR1, a Phase 2 Clinical Stage Asset for the Treatment of Lupus
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
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.
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