REHOVOT, Israel and NEW IPSWICH, N.H., May 16 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (London: XTL) announced today initiation of a Phase II clinical study of XTL-001 in combination with Lamivudine for the treatment of chronic hepatitis B virus (HBV) infection. It is anticipated that the combination treatment using XTL-001 with antivirals will reduce the incidence of drug resistance to current therapy.
Patients in the study will be treated with a combination of various doses of XTL-001 or a placebo and a standard treatment regimen of Lamivudine. The multi-center, double-blind, dose ranging study is expected to enroll 60 patients. Five dosing regimens of XTL-001 will be evaluated. Patients will receive the combination drug therapy for up to 12 months. This initial Phase II study is designed to gather clinical data regarding the appropriate dose regimen in the HBV patient population for future clinical studies. Parameters to be assessed include safety and antiviral effect.
XTL-001 consists of two high affinity human monoclonal antibodies that act at multiple sites on the HBV surface antigen. These antibodies were discovered and developed using XTL's Trimera system, a proprietary technology for producing and bio-validating high-affinity, fully human monoclonal antibodies. In a Phase I clinical study of 27 patients, various single and multiple dosing regimens of XTL-001 without Lamivudine were well tolerated and no serious adverse events were observed. Furthermore, there was a rapid and consistent decrease in HBV viral levels in all patients receiving multiple doses of XTL-001.
HBV is the most common form of hepatitis and one of the world's leading causes of death. Current therapies used for treatment of chronic HBV infection include interferon-alpha and Lamivudine. Although these treatments may reduce viral load, in the majority of patients there is not a permanent eradication of the virus. Thus new and multi-drug approaches directed to different mechanisms are needed.
``We are very pleased to commence Phase II studies for XTL-001,'' stated Martin Becker, Ph.D. President and Chief Executive Officer of XTL. ``This trial is in line with XTL's strategy of combining human monoclonal antibody based therapeutics with small molecule drugs to treat infectious diseases.''.. |
