Noxxon Pharma has secured a positive recommendation from the Data Safety Monitoring Board (DSMB) to continue recruiting patients for the NOX-A12 plus radiotherapy brain cancer study.
The independent body concluded that it is safe to continue with the enrolment after assessing safety data from the initial four weeks of treatment of the first patient recruited in the third and final dose cohort of the study.
The Phase I/II clinical study involves testing three dose regimens of NOX-A12 (200mg, 400mg and 600mg/week) along with external-beam radiotherapy in newly diagnosed brain cancer patients.
The participating clinical centres have now started final patient recruitment for the last and highest dose group. Once all patients in the third cohort have received four weeks of treatment, DSMB will again assess safety and tolerability.
The meeting will subsequently determine the recommended dose for the next randomised, controlled brain cancer trial.
Noxxon CEO Aram Mangasarian said: “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. As the study advances, we will be analysing data which will be used to define the recommended dose and guide preparations for a potentially registrational Phase II 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.”