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 all three patients of the first dose cohort have been enrolled into the brain cancer clinical trial testing the CXCL12 inhibitor, NOX-A12, and have already received the planned initial treatment. 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 in a Phase 1/2 clinical trial.
Once the last patient in the first cohort reaches four-weeks of therapy of NOX-A12 combined with radiotherapy, the independent Data Safety Monitoring Board (DSMB) will determine whether it is safe to proceed from the low to the middle dose level of NOX-A12. Under the approved protocol, it is planned that each patient is treated with NOX-A12 for up to six months.
“The combination of NOX-A12 and radiotherapy has so far been well-tolerated by the patients that participated in this clinical trial. This is a very important first step in the clinical assessment of a new treatment option for these very difficult-to-treat patients with highly aggressive brain cancer,” said Dr. Frank Giordano, Chairman of the Department of Radiation Oncology at the University Hospital Bonn.
“Due to the seriousness of the disease we are studying, recruitment into this trial continues in two of our three study centers, despite the challenges that hospital staff face as a result of the COVID-19 pandemic. Provided the next safety analysis after four weeks of treatment confirms the benign safety profile NOX-A12 has shown thus far, the trial will progress so the next patients can receive a higher dose as planned in the protocol,” commented Aram Mangasarian, CEO of NOXXON. “Six months of data from the first cohort of patients should be available in October 2020, and from the second and third cohorts in the end of Q1 2021 and mid-2021, respectively. As a measure to ensure the timely completion of the study under the current challenging conditions of the COVID-19 pandemic, we are planning to include additional clinical sites to increase recruitment capacity.”
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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