ANOTHER FAILURE OF EPOTHILONES

(RTTNews) - Swiss pharmaceutical giant Novartis AG (NVS: News ) said Thursday that its late-stage study examining patupilone for patients with advanced ovarian cancer failed to meet the primary endpoint of overall survival. Novartis informed that it does not plan to proceed with regulatory filings.

No new or unexpected serious adverse events in the patupilone arm were identified in the trial. Also, investigators involved in the study and regulatory agencies were notified of the trial outcome.

Patupilone, or EPO906, belongs to a class of microtubule stabilizers called epothilones and is being evaluated in ongoing trials in multiple tumor types, including metastatic colorectal cancer, brain metastases in non-small cell lung cancer or NSCLC and hormone-refractory prostate cancer or HRPC.

The patupilone trial was an open label, active controlled, parallel group, multicenter trial conducted in about 168 sites in 22 countries, among 829 patients with epithelial ovarian, primary fallopian or primary peritoneal cancer, who were randomized to receive patupilone or Doxil/Caelyx. The comparator arm in the trial was Doxil/Caelyx, or pegylated liposomal doxorubicin.