Cubist Pharmaceuticals, Inc. and XTL Biopharmaceuticals Ltd. jointly announced the completion of the first scheduled review by an independent data and safety monitoring board (DSMB) of the first group of 15 patients enrolled in the ongoing Phase 2 clinical trial.
The trial is the second of two planned Phase 2 trials. This study is examining the safety and efficacy of HepeX-B (libivirumab and exbivirumab for injection) for prevention of hepatitis B reinfection in patients who have received liver transplantation for end-stage hepatitis B infection, and who have been maintained on hepatitis B immune globulin (HBIg).
The clinical protocol for an open-label study of HepeX-B was designed with input from the US FDA and specifies for periodic scheduled open-label reviews of the clinical data by an independent DSMB. Based upon a review of the data provided by XTL, the DSMB, convened by Duke Clinical Research Institute at Duke University, has recommended continuation of the trial. Patients are currently being enrolled in the trial in the US and in Israel. Centres in several Western European countries will be opened shortly, the release says.
HepeX-B is a combination of two fully human monoclonal antibodies, selected using XTLbio's pre-clinical Trimera model, that target HBV surface antigens. It is currently in an international Phase 2 study for the prevention of infection by HBV in liver transplant patients who have been maintained on HBIg. In clinical studies, HepeX-B maintained serum levels similar to or higher than the current first-line treatment, HBIg, using 1,000 times less drug. HepeX-B has already been granted Orphan Drug Status in both the US and the European Union.
Hepatitis B is most commonly caused by the Hepatitis B virus, which, according to Datamonitor, has infected over 2 billion people around the world. Although a vaccine against HBV was introduced in 1982, globally, 350 million people are infected chronically with the disease and approximately 1 million people die each year as a result of complications from HBV infection.