On November 10, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that an independent Data Safety Monitoring Board (DSMB) has confirmed that it is safe and appropriate to start patient recruitment for the highest planned dose cohort for the Phase 1/2 NOX-A12 plus radiotherapy brain cancer study (Press release, NOXXON, NOV 10, 2020, View Source [SID1234570518]).
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The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The decision to proceed followed the analysis of safety data stipulated in the study protocol after all patients in the second cohort completed at least four weeks of treatment at the middle dose.
The clinical study centers participating in the study have initiated patient recruitment for the high-dose group that will receive 600 mg NOX-A12 per week. Once the first patient in the third cohort completes four weeks of treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to recruit the remaining two patients in the cohort.
"Following this analysis, the study can progress to the high-dose cohort as planned. The recent addition of three clinical sites will also greatly support the timely completion of the study, with top-line data expected in mid-2021," commented Aram Mangasarian, CEO of NOXXON.