NEOPHARM BRAIN CANCER DRUG DOESN'T ACHIEVE SIGNIFICANCE

NeoPharm has announced that the pivotal Phase III PRECISE trial evaluating cintredekin besudotox (IL13-PE38QQR) for the treatment of recurrent glioblastoma multiforme (GBM) did not meet the efficacy endpoint at 215 deaths, which was a statistically significant difference, or separation, in the overall survival curves compared with Gliadel Wafer. The data suggests that cintredekin besudotox, while comparable, was not superior to Gliadel.

The median survival time for patients on cintredekin besudotox was 36.4 weeks, while the median survival time for patients on Gliadel was 35.3 weeks. The company has created a task force to evaluate options for moving forward.

A total of 294 patients were enrolled in the PRECISE trial, of which 276 had confirmed recurrent GBM, according to a release issued after a data monitoring committee review last year.