Data Safety Monitoring Board confirms safety and validates recruitment of additional patients
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 the Data Safety Monitoring Board (DSMB), in a planned and independent review session, has analyzed safety data from the initial four weeks of treatment of the first patient of the second dose cohort enrolled in the NOX-A12 plus radiotherapy brain cancer trial. The DSMB concluded that it is safe and appropriate to continue the recruitment of additional patients according to the study protocol.
The Phase 1/2 clinical trial is testing 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 clinical centers participating in the study have now initiated the recruitment of the remaining patients in the second of three escalating dose groups. Once all patients in the second cohort have received a four-weeks treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to proceed to the highest planned dose level of NOX-A12.
“We are encouraged by the additional confirmation of the safety profile of NOX-A12 as we continue moving forward with the increasing dose regimens,” commented Aram Mangasarian, CEO of NOXXON. “Following this analysis, the trial can progress as planned, enabling further patients to receive treatment as part of the study protocol. In parallel, the recent capital raises secure our financial runway to well over one year and thereby allow us to remain focused on reaching our goal of obtaining six months of data from the first cohort of patients in October 2020, and from the second and third cohorts at the end of Q1 2021 and mid-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 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. (Read more…) 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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NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer
+49 (0) 30 726247 0
Gretchen Schweitzer or Joanne Tudorica
+49 (0) 89 2388 7730 or +49 (0) 176 2103 7191
+33 (0) 1 44 71 00 15