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 a planned review by an independent Data Safety Monitoring Board (DSMB) has analyzed safety data from ten weeks of treatment of the first patient enrolled in the NOX-A12 plus radiotherapy brain cancer trial. Based on this assessment, the DSMB has confirmed that it is appropriate to continue the recruitment of additional patients according to the study protocol.
The clinical trial centers participating in the study have therefore initiated the recruitment of the remaining patients in the first of three escalating dose groups. Once each patient in the first cohort has received a four-weeks treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to proceed to the middle dose level of NOX-A12.
“We are encouraged by this initial confirmation of the safety profile of NOX-A12,” commented Aram Mangasarian, CEO of NOXXON. “Following this analysis, the trial can progress as planned so the next patients can receive the treatment as part of the protocol. We remain focused on reaching our goal of obtaining data from the first cohort of patients in mid-2020, and from the second and third cohorts in the fourth quarter 2020 and the second quarter of 2021, respectively.”
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 in December 2018 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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