Patient receiving care in a clinical setting
Sources

References

References & Sources

All clinical, regulatory, and commercial claims on this page are drawn from peer-reviewed publications, regulatory filings, and authoritative public health data. Inline citations are marked with superscript numbers throughout.

  1. 1GLOBOCAN / WHO Global Cancer Incidence and Mortality Estimates, 2022.
  2. 2Brizel DM, et al. Phase 1/2 Trial of BMX-001 in Head & Neck Cancer. ASTRO Annual Meeting, 2021.
  3. 3Anderson CM, Lee CM, Saunders DP, et al. Avasopasem manganese treatment for severe oral mucositis from chemoradiotherapy for locally advanced head and neck cancer: Phase 3 randomized controlled trial (ROMAN). EClinicalMedicine. 2025;79:102902.
  4. 4Peters K, Cohen A, Butowski N, et al. LTBK-09. Results of BMX-HGG Study: A Multi-Institutional, Randomized Phase 2 Clinical Trial of Concurrent Chemoradiation With or Without BMX-001 in Patients With Newly Diagnosed High Grade Glioma. Neuro-Oncol. 2023;25(Suppl 5):v311. doi:10.1093/neuonc/noad179.1203.
  5. 5Sheng H, Yang W, Fukuda S, et al. Long-term neuroprotection from a potent redox-modulating metalloporphyrin in the rat. Free Radic Biol Med. 2009;47(7):917–923.
  6. 6Sheng H, Spasojevic I, Tse HM, et al. Neuroprotective efficacy from a lipophilic redox-modulating Mn(III) N-hexylpyridylporphyrin, MnTnHex-2-PyP, in rodent models of ischemic stroke and subarachnoid hemorrhage. J Pharmacol Exp Ther. 2011;338(3):906–916.
  7. 7Wang P, Li Y, Yan B, et al. Manganese porphyrin promotes post cardiac arrest recovery in mice and rats. Biology. 2022;11(7):957.
  8. 8Li X, Cao Z, Wu Y, et al. Intracarotid infusion of redox-active manganese porphyrin BMX-001 improves long-term stroke outcome in rats. Antioxidants. 2023;12(10):1861.
  9. 9Zhang S, Cao J, Spasojevic I, Treggiari M, Sheng H. Treatment with manganese porphyrin, MnTnBuOE-2-PyP5+ (BMX-001), suppressed the activation of macrophages in a mouse intracerebral hemorrhage model. Pharmaceuticals. 2025;18(4):547.
  10. 10Baskar R, Dai J, Wenlong N, Yeo R, Yeoh KW. Cancer and Radiation Therapy: Current Advances and Future Directions. Int J Med Sci. 2012;9(3):193–199. doi:10.7150/ijms.3634.
  11. 11National Institutes of Health (NIH) / National Cancer Institute (NCI) — peer-reviewed federal grant funding supporting BMX-001 preclinical and clinical development, including the NCI-funded expansion into colorectal carcinoma.
  12. 12Tong Q, Weaver MR, Kosmacek EA, et al. MnTE-2-PyP reduces prostate cancer growth and metastasis by suppressing p300 activity and p300/HIF-1/CREB binding to the promoter region of the PAI-1 gene. Free Radic Biol Med. 2016;94:185–194. doi:10.1016/j.freeradbiomed.2016.02.036.
  13. 13Tse HM, Milton MJ, Piganelli JD. Mechanistic analysis of the immunomodulatory effects of a catalytic antioxidant on antigen-presenting cells: implication for their use in targeting oxidation-reduction reactions in innate immunity. Free Radic Biol Med. 2004;36(2):233–247. doi:10.1016/j.freeradbiomed.2003.10.017.
  14. 14Tovmasyan A, Sheng H, Weitner T, et al. Design, Mechanism of Action, Bioavailability and Therapeutic Effects of Mn Porphyrin-Based Redox Modulators. Med Princ Pract. 2013;22(2):103–130. doi:10.1159/000341715.
  15. 15Noh SU, Lim J, Shin S-W, et al. Single-Cell Profiling Reveals Immune-Based Mechanisms Underlying Tumor Radiosensitization by a Novel Mn Porphyrin Clinical Candidate, MnTnBuOE-2-PyP5+ (BMX-001). Antioxidants (Basel). 2024;13(4):477.
  16. 16Batinic-Haberle I, Tovmasyan A, Spasojevic I. Mn Porphyrin-Based Redox-Active Drugs: Differential Effects as Cancer Therapeutics and Protectors of Normal Tissue Against Oxidative Injury. Antioxid Redox Signal. 2018;29(16):1691–1724. doi:10.1089/ars.2017.7453.
  17. 17Myers MS, Kosmacek EA, Liew CS, et al. BMX-001 acts as a selective chemoradioprotector in rectal cancer. Redox Biochemistry and Chemistry. 2026;16:100074. doi:10.1016/j.rbc.2026.100074.
  18. 18Lin C, et al. Phase 1/2 Trial of BMX-001 with Chemoradiation in Anal Squamous Cell Carcinoma — Reduction in Grade 3+ Toxicity (14% vs 21–36% historical). ASTRO Annual Meeting, 2024. ClinicalTrials.gov NCT03386500.
  19. 19Gad 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;35(4):438–453. doi:10.1177/1091581816642766.
  20. 20Stupp R, et al. Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma. N Engl J Med. 2005;352:987–96.
  21. 21Ajani JA, Winter KA, Gunderson LL, et al. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA. 2008;299(16):1914–1921.
  22. 22Stupp R, Taillibert S, Kanner AA, et al. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017;318(23):2306–2316. doi:10.1001/jama.2017.18718.
  23. 23Stupp R, et al. NovoTTF-100A versus Temozolomide for Glioblastoma. JAMA. 2015;314(23):2535–43.
  24. 24Le QT, Kim HE, Schneider CJ, et al. Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: a randomized, placebo-controlled study. Int J Radiat Oncol Biol Phys. 2011;80(5):1364–1372. doi:10.1016/j.ijrobp.2010.10.024.
BioMimetix

A clinical-stage oncology company developing BMX-001, a first-in-class manganese porphyrin. Preclinically, BMX-001 enhances tumor response to radiation and chemotherapy while protecting normal tissue; clinically, it has demonstrated encouraging survival, normal-tissue protection, tolerability, and function across clinical programs.

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