On March 12, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that the Data Safety Monitoring Board (DSMB) analyzed safety data from the initial four weeks of treatment of the first patient enrolled in the third and final dose cohort of the NOX-A12 plus radiotherapy brain cancer study (Press release, NOXXON, MAR 12, 2021, View Source [SID1234576595]). The DSMB concluded that it is safe and appropriate to continue patient recruitment according to the study protocol. The DSMB’s decision marks an important milestone in this trial as it enables the advancement and analysis of the final dose regimen, placing NOXXON on the path toward valuable data readouts anticipated later this year.
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The Phase 1/2 clinical study is testing three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy, in newly diagnosed brain cancer patients. Based on the DSMB’s confirmation, participating clinical centers have now initiated final patient recruitment for the last and highest dose group. After all patients in the third cohort have received four weeks of treatment with NOX-A12 and radiotherapy, the DSMB will reconvene for a final meeting to assess safety and tolerability. The outcome of this meeting will inform the recommended dose for the next randomized, controlled brain cancer trial which will lead to the registration of NOX-A12.
"We are pleased by the safety data confirmation of the DSMB, as it will allow our study to progress and the last patients to receive treatment at the highest planned dose of NOX-A12. This achievement brings us one step closer to a topline data readout for this cohort sometime around the end of Q3 2021," commented Aram Mangasarian, CEO of NOXXON. "As the study advances, we will be analyzing data which will be used to define the recommended dose and guide preparations for a potentially registrational Phase 2 study. The recent capital raise plus available financing vehicles secure NOXXON’s financial runway well into 2022, thereby allowing us to address operational matters crucial for the future of the company."