XTL Biopharmaceuticals Further Strengthens Team for Phase II Lupus Trial with Two Additional Experts
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.
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.
SOURCE XTL Biopharmaceuticals Ltd.