Noxxon Pharma said Friday that recruitment of patients in second cohort has been initiated for the middle dose cohort for the Phase 1/2 NOX-A12 plus radiotherapy brain cancer trial.
BERLIN–(BUSINESS WIRE)–Regulatory News:
NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced Friday that an independent Data Safety Monitoring Board (DSMB) has confirmed that it is safe to start patient recruitment.
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 first cohort completed at least 4 weeks of treatment.
The clinical trial centers participating in the study have therefore initiated patient recruitment for the second of three escalating dose groups who will receive NOX-A12 at a weekly dose of 400 mg/week. Once the first patient in this second cohort has received a four-week treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to recruit the remaining two patients in this cohort.
“The confirmation of the initial safety profile of NOX-A12 in combination with radiotherapy in all patients of the first cohort is very encouraging,” commented Aram Mangasarian, CEO of NOXXON. “Following this analysis, the trial can progress to the second cohort as planned at the next dose level. We remain focused on reaching our goal of obtaining data from the first cohort of patients in October 2020, and from the second and third cohorts in the end of Q1 2021 and mid-2021, respectively.”