XTL Biopharma Expands Clinical Advisory Board To Support Phase II Study Of HCDR1 In Sjogren's Syndrome
RAANANA, Israel, February 13, 2017 /PRNewswire/ --
• Dr. Robert I. Fox and Professor Simon Bowman are world-renowned rheumatologists and experts in Sjogren's syndrome
• XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases.
• Sjogren's is a substantial unmet medical need in an estimated 4 million U.S. patients and significantly expands market opportunity for XTL's lead drug candidate
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing treatments for autoimmune diseases, today announced that two leading experts in rheumatology, Robert Fox, MD and Simon Bowman, MD, have joined the Company's clinical advisory board to help guide a planned Phase II trial to evaluate the company's investigational drug, hCDR1, for the treatment of Sjögren's syndrome (SS).
Drs. Fox and Bowman join a distinguished group of leading rheumatologists on the company's advisory board, including Murray Urowitz, MD, David Isenberg, MD, Dan Wallace, MD and Lee S. Simon MD, FACP, FACR.
"Dr. Fox and Professor Bowman are internationally-recognized experts at the forefront of research in Sjögren's syndrome," said Josh Levine, CEO of XTL. "Together, they have more than 30 years of experience in the development of treatment measures for the SS. We are excited to welcome these clinicians aboard our already impressive clinical advisory board, and look forward to benefiting from their experience in trial design, dosing and other aspects of the drug development process for our Phase II trial."
Dr. Robert Fox, Chief of the Rheumatology Clinic at the Scripps-Ximed Medical Group at Scripps Memorial Hospital in La Jolla, CA, specializes in the pathogenesis and treatment of Sjögren's syndrome. He has been involved in studies of therapies to treat Sjögren's syndrome for more than 15 years, including writing clinical protocols for pivotal trials. He has edited a number of journals and pursued research as a principal investigator in multicenter clinical trials and his own NIH-funded research programs. Additionally, Dr. Fox serves as a member of the American College of Rheumatology's Advisory Board for Sjögren's Syndrome as well as the Advisory Board for the National Sjögren's Syndrome Foundation. In recent years, he has served as Rheumatology Editor for Medscape and written more than 100 articles and editorials for practicing physicians and patients.
"Sjögren's syndrome is a very difficult disease to overcome and has a severe impact on the patients' quality of life and function," said Dr. Fox. "New treatment options are urgently needed, and I am looking forward to working with XTL to evaluate the clinical impact of hCDR1 for treating the systemic manifestations of the disease."
Professor Simon Bowman has been a consultant rheumatologist for over 15 years at the Queen Elizabeth Hospital in Birmingham. He is a Fellow at the Royal College of Physicians; a past President of the British Sjögren's Syndrome Association, member of the Sjögren's Syndrome Foundation of America and past President of the British Society for Rheumatology. Professor Bowman has broad experience in all areas of rheumatology, with a particular clinical and research interest in Sjögren's syndrome. He holds an Honorary Chair at the University of Birmingham and has published widely on the topic of Sjögren's syndrome and other connective tissue disorders.
"I am pleased to support XTL'S clinical development program for hCDR1 for the treatment of Sjögren's syndrome," said Professor Bowman. "This investigational agent's therapeutic potential is supported by the results of the PRELUDE study for lupus, a similar autoimmune condition, where the agent had positive systemic effect, as well as recent pre-clinical studies that show a reduction in gene expression in three cytokines considered to be pathogenic in the disease."
About Sjögren's syndrome
Sjögren's syndrome is a systemic autoimmune disease with some autoantibodies and clinical manifestations similar to those detected in SLE. Although many patients experience dry eyes, dry mouth ,fatigue and joint pain, Sjögren's syndrome also causes dysfunction of organs such as the kidneys, gastrointestinal system, blood vessels, lungs, liver, pancreas, and the central nervous system. Patients also have a substantially higher risk of developing lymphoma. Today, as many as four million Americans are living with this disease, according to the Sjögren's Syndrome Foundation.
Current standard of care in the U.S. includes treating specific symptoms such as dry eyes, dry mouth, and arthritis. Systemic manifestations are often treated with drugs used to treat other autoimmune diseases, such as hydroxychloroquine, methotrexate, or azathioprine. However, these treatments are not sufficient in many patients and may have significant side effects. There is no approved specific drug for the treatment of systemic manifestations in Sjögren's syndrome.
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and clinical data on over 400 patients in three clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. For more information please see a peer reviewed article in Lupus Science and Medicine journal (full article).
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases. The Company's lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of autoimmune diseases including systemic lupus erythematosus (SLE) and Sjögren's Syndrome (SS). The few treatments currently on the market for these diseases are not effective enough for most patients and some have significant side effects. hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer reviewed scientific journals.
XTL is traded on the Nasdaq Capital Market (XTLB) and the Tel Aviv Stock Exchange (XTLB.TA). 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 Form 20-F filed with the U.S. Securities and Exchange Commission on March 31, 2016.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals Ltd.
Tel: +44-972-9955-7080
Email: ir@xtlbio.com
http://www.xtlbio.com
Stephanie Carrington
ICR, Inc.
+44-646-277-1282
Stephanie.Carrington@icrinc.com
Media
James Heins
ICR, Inc.
+44-203-682-8251
James.Heins@icrinc.com
• XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases.
• Sjogren's is a substantial unmet medical need in an estimated 4 million U.S. patients and significantly expands market opportunity for XTL's lead drug candidate
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing treatments for autoimmune diseases, today announced that two leading experts in rheumatology, Robert Fox, MD and Simon Bowman, MD, have joined the Company's clinical advisory board to help guide a planned Phase II trial to evaluate the company's investigational drug, hCDR1, for the treatment of Sjögren's syndrome (SS).
Drs. Fox and Bowman join a distinguished group of leading rheumatologists on the company's advisory board, including Murray Urowitz, MD, David Isenberg, MD, Dan Wallace, MD and Lee S. Simon MD, FACP, FACR.
"Dr. Fox and Professor Bowman are internationally-recognized experts at the forefront of research in Sjögren's syndrome," said Josh Levine, CEO of XTL. "Together, they have more than 30 years of experience in the development of treatment measures for the SS. We are excited to welcome these clinicians aboard our already impressive clinical advisory board, and look forward to benefiting from their experience in trial design, dosing and other aspects of the drug development process for our Phase II trial."
Dr. Robert Fox, Chief of the Rheumatology Clinic at the Scripps-Ximed Medical Group at Scripps Memorial Hospital in La Jolla, CA, specializes in the pathogenesis and treatment of Sjögren's syndrome. He has been involved in studies of therapies to treat Sjögren's syndrome for more than 15 years, including writing clinical protocols for pivotal trials. He has edited a number of journals and pursued research as a principal investigator in multicenter clinical trials and his own NIH-funded research programs. Additionally, Dr. Fox serves as a member of the American College of Rheumatology's Advisory Board for Sjögren's Syndrome as well as the Advisory Board for the National Sjögren's Syndrome Foundation. In recent years, he has served as Rheumatology Editor for Medscape and written more than 100 articles and editorials for practicing physicians and patients.
"Sjögren's syndrome is a very difficult disease to overcome and has a severe impact on the patients' quality of life and function," said Dr. Fox. "New treatment options are urgently needed, and I am looking forward to working with XTL to evaluate the clinical impact of hCDR1 for treating the systemic manifestations of the disease."
Professor Simon Bowman has been a consultant rheumatologist for over 15 years at the Queen Elizabeth Hospital in Birmingham. He is a Fellow at the Royal College of Physicians; a past President of the British Sjögren's Syndrome Association, member of the Sjögren's Syndrome Foundation of America and past President of the British Society for Rheumatology. Professor Bowman has broad experience in all areas of rheumatology, with a particular clinical and research interest in Sjögren's syndrome. He holds an Honorary Chair at the University of Birmingham and has published widely on the topic of Sjögren's syndrome and other connective tissue disorders.
"I am pleased to support XTL'S clinical development program for hCDR1 for the treatment of Sjögren's syndrome," said Professor Bowman. "This investigational agent's therapeutic potential is supported by the results of the PRELUDE study for lupus, a similar autoimmune condition, where the agent had positive systemic effect, as well as recent pre-clinical studies that show a reduction in gene expression in three cytokines considered to be pathogenic in the disease."
About Sjögren's syndrome
Sjögren's syndrome is a systemic autoimmune disease with some autoantibodies and clinical manifestations similar to those detected in SLE. Although many patients experience dry eyes, dry mouth ,fatigue and joint pain, Sjögren's syndrome also causes dysfunction of organs such as the kidneys, gastrointestinal system, blood vessels, lungs, liver, pancreas, and the central nervous system. Patients also have a substantially higher risk of developing lymphoma. Today, as many as four million Americans are living with this disease, according to the Sjögren's Syndrome Foundation.
Current standard of care in the U.S. includes treating specific symptoms such as dry eyes, dry mouth, and arthritis. Systemic manifestations are often treated with drugs used to treat other autoimmune diseases, such as hydroxychloroquine, methotrexate, or azathioprine. However, these treatments are not sufficient in many patients and may have significant side effects. There is no approved specific drug for the treatment of systemic manifestations in Sjögren's syndrome.
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and clinical data on over 400 patients in three clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. For more information please see a peer reviewed article in Lupus Science and Medicine journal (full article).
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases. The Company's lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of autoimmune diseases including systemic lupus erythematosus (SLE) and Sjögren's Syndrome (SS). The few treatments currently on the market for these diseases are not effective enough for most patients and some have significant side effects. hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer reviewed scientific journals.
XTL is traded on the Nasdaq Capital Market (XTLB) and the Tel Aviv Stock Exchange (XTLB.TA). 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 Form 20-F filed with the U.S. Securities and Exchange Commission on March 31, 2016.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals Ltd.
Tel: +44-972-9955-7080
Email: ir@xtlbio.com
http://www.xtlbio.com
Stephanie Carrington
ICR, Inc.
+44-646-277-1282
Stephanie.Carrington@icrinc.com
Media
James Heins
ICR, Inc.
+44-203-682-8251
James.Heins@icrinc.com