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
Intent-to-Treat Population — Primary Analysis4
Multi-center, 1:1 randomized trial (N=160) — BMX-001 + RT/TMZ vs. RT/TMZ alone
32.2 mo
mOS — BMX-001+RT/TMZ
95% CI (21.8, not reached)
27.6 mo
mOS — RT/TMZ alone
95% CI (19.8, 33.8)
Efficacy-Evaluable Population (N=145)4
N=74 BMX-001+RT/TMZ vs. N=71 RT/TMZ alone
31.3 mo
mOS — BMX-001+RT/TMZ
SAP-specified population
24.7 mo
mOS — RT/TMZ alone
SAP-specified population
Clinical Context
High-grade glioma is one of the most lethal solid tumors. Compare to drugs that received full FDA approval:
+2.5 mo
+4.0 mo
+4.6 mo
BMX-001 +4.6 mo gain in ITT population (Figure 1A); +6.6 mo in efficacy-evaluable population (Figure 1B).
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.