Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001

Summary

This is a Phase 2 study of newly diagnosed patients with high grade glioma (HGG) undergoing standard radiation therapy and temozolomide treatment. BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against deterioration of cognition and impairment of quality of life. BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. Both safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be assessed. Eighty patients will be randomized to the treatment arm that will receive BMX-001 while undergoing chemoradiation and 80 patients randomized to receive chemoradiation alone. The sponsor hypothesizes that BMX-001 when added to standard radiation therapy and temozolomide will be safe at pharmacologically relevant doses in patients with newly diagnosed high grade glioma. The sponsor also hypothesizes that the addition of BMX-001 will positively impact the overall survival and improve objective measures of cognition in newly diagnosed high grade glioma patients.

Timeline

Start

2018-09-25

Primary completion

2023-08-17

Completion

2024-12-31

Publications

• Background Jones LW, Cohen RR, Mabe SK, West MJ, Desjardins A, Vredenburgh JJ, Friedman AH, Reardon DA, Waner E, Friedman HS. Assessment of physical functioning in recurrent glioma: preliminary comparison of performance status to functional capacity testing. J Neurooncol. 2009 Aug;94(1):79-85. doi: 10.1007/s11060-009-9803-x. Epub 2009 Feb 11.
• Background Moulder JE, Cohen EP. Future strategies for mitigation and treatment of chronic radiation-induced normal tissue injury. Semin Radiat Oncol. 2007 Apr;17(2):141-8. doi: 10.1016/j.semradonc.2006.11.010.
• Myers MS, Kosmacek EA, Liew CS, Lushnikov AJ, Chatterjee A, Marky LA, Riethoven JM, Oberley-Deegan RE. BMX-001, a clinically relevant radioprotector, can reverse radiation-induced fibrosis when given three weeks after radiation, in part, by restoring methylation. Redox Biol. 2026 Mar;90:104020. doi: 10.1016/j.redox.2026.104020. Epub 2026 Jan 10.
• Gad SC, Sullivan DW Jr, Spasojevic I, Mujer CV, Spainhour CB, Crapo JD. Nonclinical Safety and Toxicokinetics of MnTnBuOE-2-PyP5+ (BMX-001). Int J Toxicol. 2016 Jul;35(4):438-53. doi: 10.1177/1091581816642766. Epub 2016 Apr 20.

Drugs

Indications