New Compound in Development for Patients with Chronic HCV
XTL Announces the Completion of Phase I Study with XTL-6865 in Patients with Chronic Hepatitis C
XTL Biopharmaceuticals Ltd. announced today the completion of the Phase I study with XTL-6865.
NEW YORK, NY, USA | Mar 29, 2007| XTL Biopharmaceuticals Ltd. announced today the completion of the Phase I study with XTL-6865. The primary goal of this Phase I study was to evaluate safety and pharmacokinetic properties of XTL-6865 in patients with chronic hepatitis C. XTL-6865, which targets the E2 envelope protein of the hepatitis C virus, is comprised of two fully-human monoclonal antibodies and is administered intravenously. The study enrolled 32 patients into 8 cohorts, each comprised of 3 treated patients and 1 placebo patient. Of the 8 cohorts in the study, the first 7 were single administration cohorts with doses ranging from 5mg to 2400mg. The 8th cohort received 1200mg for 5 consecutive days.
In this study, XTL-6865 was shown to be safe at high doses (up to 1200mg for 5 consecutive daily doses and a single dose of 2400mg). The study also enabled the Company to establish the pharmacokinetic properties of XTL-6865 in patients with chronic hepatitis C. For all single doses, the t-max was reached immediately at the end of the XTL-6865 infusion. For the highest single dose, 2400mg, the C-max was between 500 and 1000 microg/ml and the t1/2 was approximately 5 days. For the lower single doses, the t1/2 was 2-3 days. The study provided evidence of binding of the antibody to circulating virus and the formation of immune complexes (antibody-virus), believed to be important for virus neutralization in the serum. No statistically significant changes in HCV-RNA were observed. Given the short duration of administration of XTL-6865, and the fact the patients in this study had a high rate of viral replication at baseline, no significant change in viral load was to be expected.
The results of this Phase I trial potentially pave the way for trials that would evaluate XTL-6865 in patients with hepatitis C undergoing liver transplantation – a potential target patient population for this drug – or in chronic hepatitis C patients with low viral load. XTL intends to seek a collaborative partnership for the future development of this compound.
Ron Bentsur, CEO of XTL Biopharmaceuticals, commented, “This trial enabled us to determine the pharmacokinetic properties of XTL-6865, and to demonstrate that it could be safely administered to patients at high doses. This study also clearly demonstrated that the antibody binds to the circulating virus in the serum. We believe that XTL-6865 could potentially play a role in certain clinical settings, such as preventing re-infection of hepatitis C following liver transplantation or in chronic hepatitis C patients who have low viral loads following treatment with other anti-hepatitis C drugs. We believe this is now an appropriate time to seek to out-license the compound.” Mr. Bentsur continued, “We intend to focus our resources on commencing our clinical program for Bicifadine, for the treatment of diabetic neuropathic pain, and on completing our Phase I study for XTL-2125, our small-molecule compound for the treatment of chronic hepatitis C.”
About XTL Biopharmaceuticals Ltd.
XTL Biopharmaceuticals Ltd. (“XTL”) is engaged in the acquisition, development and commercialization of therapeutics for the treatment of neuropathic pain and hepatitis C. XTL is developing Bicifadine, a serotonin and norepinephrine reuptake inhibitor, for the treatment of neuropathic pain. In addition, XTL is developing XTL-2125 – a small molecule, non-nucleoside inhibitor of the hepatitis C virus polymerase. XTL-2125 is currently in a Phase I clinical trial in patients with chronic hepatitis C. XTL is also developing XTL-6865 – a combination of two monoclonal antibodies against the hepatitis C virus. XTL’s hepatitis C pipeline also includes several families of pre-clinical hepatitis C small molecule inhibitors. XTL also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. XTL is publicly traded on the NASDAQ, London, and Tel-Aviv Stock Exchanges.
SOURCE: XTL Biopharmaceuticals Ltd.