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 that an independent Data Safety Monitoring Board (DSMB) has confirmed that it is safe to start patient recruitment for the middle dose cohort for the Phase 1/2 NOX-A12 plus radiotherapy brain cancer trial.
The 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. The decision to proceed followed the analysis of safety data stipulated in the study protocol after all patients in the first cohort completed at least 4 weeks of treatment.
The clinical trial centers participating in the study have therefore initiated patient recruitment for the second of three escalating dose groups who will receive NOX-A12 at a weekly dose of 400 mg/week. Once the first patient in this second cohort has received a four-week treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to recruit the remaining two patients in this cohort.
“The confirmation of the initial safety profile of NOX-A12 in combination with radiotherapy in all patients of the first cohort is very encouraging,” commented Aram Mangasarian, CEO of NOXXON. “Following this analysis, the trial can progress to the second cohort as planned at the next dose level. We remain focused on reaching our goal of obtaining data from the first cohort of patients in October 2020, and from the second and third cohorts in the end of Q1 2021 and mid-2021, respectively.”
About 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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