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Also known as MTX-110, MTX110 (CN)
Panobinostat Nanoparticle Formulation MTX110 · 1 trial · 1 indication
Adverse events and clinically significant laboratory abnormalities which meet Grade 3, 4, or 5 criteria according to Common Terminology Criteria for Adverse Events (CTCAE) classified by investigators and treating physicians as related to study treatment (probable, possible, and definite) will be summarized by maximum intensity/grade. Adverse events will be graded according to CTCAE version 4.0.
| Arm | Type | Description |
|---|---|---|
| Treatment (MTX110) | EXPERIMENTAL | Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Panobinostat Nanoparticle Formulation MTX110 | DRUG | Given IT |
| Convection-Enhanced Delivery (CED) | DRUG | Undergo CED |
Inclusion Criteria: * Patients with newly diagnosed DIPG by magnetic resonance imaging (MRI); defined as patients with a pontine location and diffuse involvement of at least 2/3 of the pons are eligible without histologic diagnosis. For lesions with typical imaging features, biopsy is neither encou...
MTX110 is being studied for the treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG), a rare and aggressive pediatric brain tumor. It is an investigational therapy and has not been approved for any indication. The clinical program has focused on delivering the drug directly to the tumor site in the brainstem.
MTX110 is a nanoparticle formulation of panobinostat, a small molecule histone deacetylase (HDAC) inhibitor. It targets HDAC1, HDAC2, HDAC3, HDAC5, HDAC6, and HDAC7. By inhibiting these enzymes, the drug is designed to alter gene expression and interfere with tumor cell growth in diffuse intrinsic pontine glioma.
MTX110 is being developed by Biodexa Pharmaceuticals plc, which trades under the ticker BDRX. The company is advancing the nanoparticle formulation of panobinostat as an investigational treatment for diffuse intrinsic pontine glioma, with clinical activity conducted in the United States.
MTX110 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program has been completed, and the candidate remains in early-stage clinical evaluation for newly diagnosed diffuse intrinsic pontine glioma.
MTX110 has been evaluated in the Phase 1 trial NCT03566199, titled MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma. The trial enrolled 7 participants in the United States, was uncontrolled, and has been completed. It included patients aged 2 years and older.