On October 14, 2020 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that all three patients of the second dose cohort have been enrolled into the brain cancer clinical trial testing CXCL12 inhibitor, NOX-A12, and have already received the planned initial treatment (Press release, NOXXON, OCT 14, 2020, View Source [SID1234568428]). The Phase 1/2 clinical study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed brain cancer patients.
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Once the last patient in the second cohort completes four weeks of therapy of NOX-A12 and radiotherapy, the independent Data Safety Monitoring Board (DSMB) will determine whether it is safe to proceed from the middle to the highest dose level of NOX-A12. The approved protocol plans for each patient to be treated with NOX-A12 for up to six months.
"The combination of NOX-A12, at both low and middle doses, and radiotherapy has been well tolerated by the patients participating in this clinical trial. Recruitment of the last cohort could start as early as November once the next safety analysis confirms benign safety profile of NOX-A12," said Dr. Frank Giordano, Chairman of the Department of Radiation Oncology at the University Hospital Bonn.
"Completing patient recruitment is an important step in the continued clinical assessment of this novel therapy for patients with difficult-to-treat and highly aggressive brain cancer. As a measure to ensure the timely completion of the study under the current challenging conditions posed by the COVID-19 pandemic, we will soon open additional clinical sites in Germany to increase recruitment capacity," commented Aram Mangasarian, CEO of NOXXON.