On September 12, 2019 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 the start of recruitment of newly diagnosed brain cancer patients in a Phase 1/2 clinical trial combining the CXCL12 inhibitor NOX-A12 with radiotherapy (Press release, NOXXON, SEP 12, 2019, View Source [SID1234539484]). NOX-A12 is thought to inhibit the influx of "repair cells" from the bone marrow to the tumor, an unwanted consequence of radiotherapy that leads to a replacement of the destroyed blood vessels within the tumor which ultimately results in a recurrence of the disease.
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The safety and first efficacy data obtained in this study will support the definition of a Recommended Phase 2 Dose (RP2D) for this new treatment approach to guide further clinical developments. The non-invasive assessment of the changes in tumor vascularization by MRI is expected to confirm the predicted mechanism mode of action for the inhibition of CXCL12 in combination with radiotherapy.
"NOX-A12 combined with radiotherapy is a novel and promising approach with the potential to effectively treat brain cancer patients for which there are currently no optimal therapies. The demand from the clinical community to test this combination has been very strong and we are pleased to initiate this trial. We expect data from the first cohort of patients to be available in mid-2020," said Jarl-Ulf Jungnelius, Chief Medical Officer of NOXXON.
The trial will be conducted at three hospitals in Germany. Up to three escalating doses of NOX-A12 will be administered in combination with standard radiotherapy to newly diagnosed patients with brain tumors who would not benefit from the current standard of care of chemoradiotherapy and whose tumors cannot be fully resected by surgery. The main objective of the study is to assess the safety and tolerability of this combination. Secondary endpoints include activity of the therapy, assessed through the monitoring of tumor vascularization by MRI scans, progression-free survival, overall survival and rates of response.
CEO of NOXXON, Aram Mangasarian, will host a webinar on September 23, 2019 at 03.00 p.m. CEST, and will be joined by Dr. Frank Giordano, Vice Chairman of Radiation Oncology Department at University Medical Centre Mannheim for the presentation and Q&A session. To join the webinar, please send an email to [email protected].