On July 24, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (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), in a planned and independent review session, has analyzed safety data from the initial four weeks of treatment of the first patient of the second dose cohort enrolled in the NOX-A12 plus radiotherapy brain cancer trial (Press release, NOXXON, JUL 24, 2020, View Source [SID1234562308]). The DSMB concluded that it is safe and appropriate to continue the recruitment of additional patients according to the study protocol.
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The Phase 1/2 clinical trial 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. The clinical centers participating in the study have now initiated the recruitment of the remaining patients in the second of three escalating dose groups. Once all patients in the second cohort have received a four-weeks treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to proceed to the highest planned dose level of NOX-A12.
"We are encouraged by the additional confirmation of the safety profile of NOX-A12 as we continue moving forward with the increasing dose regimens," commented Aram Mangasarian, CEO of NOXXON. "Following this analysis, the trial can progress as planned, enabling further patients to receive treatment as part of the study protocol. In parallel, the recent capital raises secure our financial runway to well over one year and thereby allow us to remain focused on reaching our goal of obtaining six months of data from the first cohort of patients in October 2020, and from the second and third cohorts at the end of Q1 2021 and mid-2021, respectively."