XTOL Bio starts Ph II of chronic hep B drug

Israel's XTL Biopharmaceuticals has initiated a Phase III trial ofCTL-001 in combination with lamivudine (GlaxoSmithKine's Epivir) for the treatment of chronic hepatitis B virus infection. The multi-center, double-blind, dose-ranging study is expected to enroll 60 patients, and it is anticipated that the combination therapy will reduce the incidence of drug resistance to current therapy, which includes interferon alfa and lamivudine.

In a Phase I trial of 27 patients, various single- and multiple-dosing regimens of XTL-001 without lamivudine were well tolerated and no serious adverse events were observed, the company says, and there was a rapid and consistent decrease in HBV viral levels in all patients receiving multiple doses of the drug.