NOXXON Announces That Data Safety Monitoring Board Validates Further NOX-A12 Dose Escalation in Phase 1/2 Brain Cancer Study
Recruitment of patients in the high-dose cohort has been initiated
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 and appropriate to start patient recruitment for the highest planned dose cohort for the Phase 1/2 NOX-A12 plus radiotherapy brain cancer study.
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 second cohort completed at least four weeks of treatment at the middle dose.
The clinical study centers participating in the study have initiated patient recruitment for the high-dose group that will receive 600 mg NOX-A12 per week. Once the first patient in the third cohort completes four weeks of treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to recruit the remaining two patients in the cohort.
“Following this analysis, the study can progress to the high-dose cohort as planned. The recent addition of three clinical sites will also greatly support the timely completion of the study, with top-line data expected in mid-2021,” commented Aram Mangasarian, CEO of NOXXON.
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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Contacts
NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer
+49 (0) 30 726247 0
[email protected]
Trophic Communications
Gretchen Schweitzer or Joanne Tudorica
+49 (0) 172 861 8540 or +49 (0) 176 2103 7191
[email protected]
NewCap
Arthur Rouillé
+33 (0) 1 44 71 00 15
[email protected]