OncoGenex Phase 3 ENSPIRIT Trial Continuing As Planned

(RTTNews) - OncoGenex Pharmaceuticals, Inc. (OGXI) Thursday said the Phase 3 ENSPIRIT trial, evaluating custirsen in the treatment of non-small cell lung cancer or NSCLC, is continuing as planned as per the recommendation of the Independent Data Monitoring Committee, based upon completion of the first interim futility analysis.

"While the results of the study remain blinded to OncoGenex and Teva, we are very pleased that ENSPIRIT has passed this important early interim futility analysis," said Scott Cormack, President and CEO of OncoGenex.

The Phase 3 ENSPIRIT trial is an international, randomized, open-label trial. It is designed to evaluate a survival benefit for custirsen in the treatment of advanced or metastatic non-small cell lung cancer in 1,100 patients who have progressed after initial chemotherapy treatment.

Patients are randomized to receive custirsen plus docetaxel or docetaxel alone. Patient enrollment to ENSPIRIT was initiated by Teva in September 2012.

Two interim futility analyses are planned for stopping the trial. The first of these two futility analyses has now been completed. A second futility analysis will be conducted later in the trial.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the evaluation of custirsen in the ENSPIRIT trial.

OGXI closed down 1.9 percent on Thursday, but added 4.8 percent in the extended trade.