On December 7, 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 first patient was enrolled in an expansion arm of the GLORIA clinical trial of NOX-A12 in MGMT unmethylated brain cancer (glioblastoma, GBM) (Press release, NOXXON, DEC 7, 2021, View Source [SID1234596561]). The patient has received their first week of treatment of NOX-A12 (600 mg/week) and the VEGF inhibitor bevacizumab combined with radiotherapy.
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The GLORIA Phase 1/2 clinical trial evaluates the safety and efficacy of NOX-A12 combined with radiotherapy. In three expansion arms, the synergistic benefit of NOX-A12 with other therapeutic settings will be evaluated:
Arm A: NOX-A12 with radiotherapy in patients with complete tumor resection
Arm B: NOX-A12 with radiotherapy and bevacizumab in patients with incomplete tumor resection
Arm C: NOX-A12 with radiotherapy and anti-PD-1 in patients with incomplete tumor resection.
Each expansion arm plans to evaluate 6 patients.
Aram Mangasarian, CEO of NOXXON, commented: "After the compelling results seen with NOX-A12 in glioblastoma patients in the GLORIA trial when combined only with radiotherapy, we are excited to move forward and explore additional treatment combinations that will potentially bring further benefits to these very difficult to treat patients. At this point, we are planning to prioritize recruitment to the bevacizumab and pembrolizumab arms and look forward to seeing the results."
Expansion arms A and B have already been approved by the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte), while the third arm is still under review. The expansion arms aim at providing additional clinical data to support the design of the planned pivotal trial and discussions with the regulatory agencies.