Germany-based biotechnology company Noxxon Pharma has reportedly received a positive outlook from the DSMB (Data Safety Monitoring Board) and will continue with the patient recruitment process for its brain cancer study called NOX-A12 plus radiotherapy.
The DSMB declared that it would be safe to continue with the enrollment after evaluating the security and safety aspects from 4 weeks of diagnosis of the very first candidate recruited during the third as well as the final dose of the study.
The Phase 1, or Phase 2 clinical study encompasses three-dose treatments of NOX-A12, along with external-beam radiotherapy among the newly detected brain cancer patient population. Moreover, the participating clinical facilities have now begun final patient recruitment for the last and the highest dose group.
It has been reported that once all patients in the third cohort have received 4 weeks of treatment, DSMB would again assess the tolerability and safety. Besides, the meeting would subsequently highlight the recommended dose for the next controlled, randomized brain cancer trial.
Commenting on the latest move, Aram Mangasarian, CEO at Noxxon Pharma reportedly cited that the company is thrilled to have acquired a safety data confirmation from the DSMB, further allowing the firm to study as well as provide patients a secure treatment option at an optimum planned dose of NOX-A12.
The CEO further mentioned that this approval brings Noxxon Pharma a step closer to a topline data readout for this cohort sometime around Q3 2021 end. Additionally, as the study proceeds, the company will look to analyze data that would be used to determine the endorsed dose and guide preparations and formulations for a potentially registrational Phase 2 analysis.
Mangasarian further quoted that the latest capital raised, and the available funding avenues have secured the Noxxon Pharma’s financial pathway well into 2022, thus enabling the company to address the operational issues which are likely to be critical for its future growth.
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