VBLT - VBL Therapeutics climbs on amendment to cancer study

VBL Therapeutics (VBLT) has added ~8.0% in the pre-market after announcing an amendment to its OVAL study, a phase 3 randomized pivotal trial evaluating the combination of VB-111 and paclitaxel against placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer.In addition to the previously defined primary endpoint of the trial, overall survival ((OS)), the company has now added a second, separate primary endpoint, the progression-free survival ((PFS)).The meeting of either endpoint is expected to be sufficient to support a marketing application, the company said citing a review conducted by the FDA on the changes.The meeting of the PFS endpoint is likely to speed up the BLA submission by approximately one year as opposed to the timeline based on a readout on OS primary endpoint which is anticipated in 2023.The study amendment and an update on the enrollment of the trial which has exceeded 260 patients as of April end will be part of

For further details see:

VBL Therapeutics climbs on amendment to cancer study