NOXXON files application for phase 1/2 clinical trial combining NOX-A12 & radiotherapy for the treatment of brain cancer patients
Company aims to be ready to launch the trial in Q2-2019
Berlin, Germany, February 27, 2019 – NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today that it has filed the clinical trial application (CTA) with the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), to start a Phase 1/2 clinical trial combining NOX-A12 with radiotherapy to treat newly diagnosed brain cancer patients who would not benefit from the current standard of care and whose tumor cannot be fully resected by surgery.
NOXXON plans to conduct the trial in collaboration with investigators at three hospitals in Germany: Mannheim, Essen and Bonn. The primary endpoint of this dose escalation study, which will assess up to three doses of NOX-A12, is the safety and tolerability of NOX-A12 combined with radiotherapy. Secondary endpoints include activity of the therapy, assessed through the monitoring of tumor vascularization by MRI scans, progression-free survival, overall survival and rates of response.
“Provided we can rapidly address any regulatory questions from the independent ethics committee, we should be ready to initiate the trial in mid-2019. The combination of NOX-A12 with radiation is the second therapeutic approach that we have developed for solid tumors and we believe that it can be applicable to many tumor types. We are encouraged by the strong support of clinical experts in both, the US and Europe,” said Dr. Jarl Ulf Jungnelius, Chief Medical Officer of NOXXON Pharma.