Clinical Evidence
A Growing Clinical Evidence Base.
Across clinical studies in head and neck cancer, high-grade glioma, and anal cancer malignancies, BMX-001 has shown encouraging evidence of normal-tissue protection, tolerability, and anti-tumor activity when administered with standard chemoradiation221.
High-Grade Glioma — Randomized Phase 2 survival and safety evidence
The Problem in High-Grade Glioma
- High-grade glioma is among the most lethal solid tumors. With the standard Stupp regimen (radiation + temozolomide), median survival is about 15 months — and even the most recent approved advance, tumor-treating fields added in 2017, extends it only to roughly 20 months.22
- Yet despite this lethality, high-grade glioma remains one of oncology's most underserved markets — a setting where any meaningful improvement in survival could represent a significant commercial opportunity, subject to regulatory review and approval.
- Radiation also injures the brain it treats, driving cognitive decline and white-matter damage. Patients need more than incremental survival — they need a therapy that extends life while protecting the brain and preserving quality of life during and after treatment.
Randomized Phase 2 — High-Grade Glioma4
Multi-center, 1:1 randomized trial (N=160) — BMX-001 + SOC vs. SOC alone
+0.0 mo
Median OS Gain
Primary endpoint achieved
Phase 3
Ready
Regulatory Status
FDA Fast Track + Orphan Drug
✓
Cognition Preserved
Positive trend vs. SOC alone
✓
White Matter Protected
Confirmed by diffusion tensor imaging