HERZLIYA, Israel, May 19, 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 the appointment of consultants Lee S. Simon, MD, FACP, FACR and David Isenberg, MD, for the planned Phase II
trial for the Company's hCDR1 compound for the treatment of Lupus
(Systemic Lupus Erythematosus – SLE) patients.
"Dr. Simon and Professor Isenberg are two of the industry's most
knowledgeable experts in lupus drug development, who we believe
will be major contributors to our Phase II lupus trial," said
Josh Levine, CEO of XTL. "Dr. Simon
and Prof. Isenberg each have over 20 years of experience with
lupus, rheumatology and the development of disease activity
measures, with a specific interest in the lupus indication. In
fact, Prof. Isenberg was one of the creators of the BILAG index,
one of the endpoints currently recommended by the FDA, while Dr.
Simon was a former Division Director within the US Center for Drug
Development and Research (CDER) at the FDA and worked on the now
available guidance document regarding drug development in SLE.
Their combined guidance will be an integral part of advancing this
trial."
Dr. Lee Simon has been a
rheumatologist for 36 years. He has extensive experience in drug
development in the US, and has served on consulting advisory boards
for many different companies and federal associations including
more than seven years as a voting member of various advisory
committees for the U.S. FDA and then served as a Division
Director of Analgesic, Anti- inflammatory and Ophthalmologic Drug
Products for several years.
He has been awarded the 2003 Distinguished Service Award of the
ACR and has been awarded the 2003 Scientific Leadership Award of
the Lupus Research Institute. He served on the Steering
Committee of IMPAACT, a group developing recommendations for the
design and implementation of clinical trials investigating
pain. Dr. Simon has also been on the editorial board of
multiple journals and has authored more than 110 original
publications, review articles and chapters, and has served as a
co-editor of four books.
"I am pleased to join the XTL team to support the Company's
Phase II trial for lupus," said Dr. Simon. "With the exception of
Benlysta, over the last 50 years, there has been no other potential
therapy yet that has been able to successfully navigate FDA
regulations and achieve commercialization. I look forward to
assisting in the development of hcDR1 toward this end."
Professor David Isenberg's
principal clinical interests have been in the development of
disease activity and damage assessment tools in patients with
lupus. From 2004-2006, he was the president of the British Society
for Rheumatology and, from 2006-2011, he chaired the Society's
Biologics Register Committee. From 1998-2003, he was Chairman of
the Systemic Lupus International Collaborating Clinics group
(SLICC). He continues to chair the BILAG Group and Lupus UK's
research committee. He is also an executive director of the UK's
Arthritis Research UK charity.
Prof. Isenberg received the 2010 Evelyn Hess Prize from the
Lupus Foundation of America for his contribution to lupus research
and treatment and the Rodger Demers Prize (Canada), in 2012, for his contribution to
international rheumatology.
"Throughout the course of my career, I have been studying
treatments for lupus, a debilitating and complex disease that
plagues approximately 5 million patients, worldwide," said
Professor Isenberg. "I am happy to serve as a consultant for XTL's
Phase II trial testing for hcDR1 using the BILAG index because it
has shown encouraging results when used during the previously
conducted PRELUDE trial. I am eager to begin the trial and offer my
expertise, as this modified Phase II trial is a significant step in
the right direction for trying to fight this disease."
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 lupus, multiple myeloma and schizophrenia.
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 press release 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.
Investor Contacts:
Jeffrey
Goldberger / Garth
Russell
KCSA Strategic Communications
Phone: 212-896-1249 / 212-896-1250
Email: jgoldberger@kcsa.com / grussell@kcsa.com
SOURCE XTL Biopharmaceuticals Ltd.