RAANANA, Israel, January 13, 2016 /PRNewswire/ --
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTL) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, today announced that it has reached agreement with CyDex Pharmaceuticals Inc. (La Jolla, CA) (CyDex) for the use and supply of Captisol® in the formulation of its lead drug, hCDR1, for the treatment of systemic lupus erythematosus (SLE).
The agreement grants XTL a non-exclusive, royalty-free license to use Captisol® in the formulation of its drug for the purpose of conducting its advanced clinical study on hCDR1 for the treatment of SLE subject to the payment of certain milestone and other payments.
Josh Levine, Chief Executive Officer of XTL, commented, "We are pleased with the completion of this strategic agreement with CyDex for the use and supply of Captisol®. This partnership represents a key element of our preparations for the advanced clinical study of hCDR1 and together with our agreement with BioConnection NV for the production of our drug product, we believe this will advance much of the chemistry manufacturing and control activities required prior to IND approval."
"With our progress on the production of the drug product and an FDA response to our proposed study design expected in early 2016, we are positioning ourselves to initiate the trial in the second half of 2016. We believe that hCDR1 has the potential to be a 'first in class' and 'best in class' drug in an area with a significant unmet medical need. There is currently no effective solution for SLE in the market and the competitive pipeline is remarkably weak," Levine added.
hCDR1 is a novel compound with a unique mechanism of action and with clinical data on over 400 patients in 3 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 further information please see a peer reviewed article in Lupus Science and Medicine journal (full article).
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. There has been only one drug approved by the FDA in the last over 50 years and recently two of the few drugs in advanced development did not meet their primary endpoints in Phase 3 trials.
Captisol® is a patent protected, uniquely modified cyclodextrin, whose chemical structure was rationally designed to enable the creation of new products by significantly improving solubility, stability, bioavailability and dosing of active pharmaceutical ingredients (APIs).
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 with a focus on treatments for autoimmune diseases.
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 Tech Index.
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SOURCE XTL Biopharmaceuticals Ltd