BERLIN–(BUSINESS WIRE)–Regulatory News:
NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today the collaboration with three additional clinical sites to increase recruitment capacity for the Phase 1/2 brain cancer study of NOX-A12 plus radiotherapy, as a measure to ensure the timely completion of the study under the current challenging conditions posed by the COVID-19 pandemic.
Along with the hospitals in Mannheim, Essen and Bonn, which have been participating in the recruitment of patients for the study since mid-2019, NOXXON will also collaborate with investigators at three additional hospitals in Leipzig, Münster and Tübingen, Germany.
The clinical Phase 1/2 trial 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. Having completed patient recruitment in the first and second dose cohort, all six centers will continue enrolling patients into the highest dose cohort. Top-line data from the study is expected in mid-2021.
“Timely completion of recruitment remains our main focus for this trial. Adding these new clinical sites enables us to increase recruitment capacity and to diversify the geographical distribution of the study in light of the COVID-19 pandemic. We are very pleased to receive the support of three prominent clinical sites in Tübingen, Leipzig and Münster to contribute to this important study,” commented Aram Mangasarian, CEO of NOXXON.
NOXXON’s oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier and blocking tumor repair. By neutralizing chemokines in the tumor microenvironment, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. Building on extensive clinical experience and safety data, the lead program NOX-A12 has delivered top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients and further studies are being planned in these indications. In September 2019 the company initiated an additional trial with NOX-A12 in brain cancer in combination with radiotherapy. The combination of NOX-A12 and radiotherapy has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. The company’s second clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the innate immune system. NOXXON plans to test NOX-E36 in patients with solid tumors both as a monotherapy and in combination. Further information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp
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