Northwest Biotherapeutics (NWBO) is way overdue disclosing results from an interim analysis of a phase III study of its brain cancer vaccine DCVax.
Twelve weeks have passed since Northwest Bio said independent data monitors were taking their first look at the study, which compares DCVax to placebo in patients with newly diagnosed glioblastoma mutliformae (GBM).
Results from the interim analysis were expected no later than the first week of February, Northwest Bio said. On Feb. 10, Northwest Bio CEO Linda Powers, speaking at the BIO CEO healthcare investor conference, said data monitors needed "another couple of weeks" to complete their work.
We're now another week beyond Power's acknowledged delay and still no word from the company.
Last March -- almost one year ago, actually -- Northwest Bio told investors enrollment in the 312-patient GBM study of DCVax would be completed this quarter or early in the second quarter, and that the first interim analysis would be conducted in the third quarter of 2013.
Northwest Bio spokesperson Farrell Kramer would not disclose the current number of GBM patients enrolled in the DCVax study. "We're not at liberty to provide any information to you that has not been announced publicly," Kramer said, via email.
The DCVax study in GBM has gone through numerous design changes and patient enrollment freezes since it was started in 2005 as a small, non-randomized phase II study expected to enroll 90 patients. In addition to upsizing to 312 newly diagnosed GBM patients, Northwest Bio added a placebo arm to the study and changed its designation to "phase III" -- implying positive results could be used to support an FDA approval filing.