NeoPharm has received notification that the company's cintredekin besudotox (IL13-PE38QQR) Pivotal Phase III PRECISE trial for the treatment of glioblastoma multiforme (GBM), the most aggressive form of brain cancer, has achieved the 270 intent-to-treat patient enrollment milestone, as established by the PRECISE trial protocol. The PRECISE trial protocol allows for enrollment of up to 300 patients in order to obtain 270 patients with confirmed GBM at first recurrence at study entry surgical resection, for the intent-to-treat patient population. Only 288 patients were required to be enrolled to meet the 270 intent-to-treat patient population.
The company reported in November that it had been notified by an independent data monitoring committee that the study had reached the criterion for the second futility analysis (100 deaths). In May, the company reported that it had been notified by the committee that the study had reached the criterion for the first futility analysis (50 deaths) and should proceed as planned.