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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...
Panobinostat Nanoparticle Formulation MTX110 is used for Diffuse Intrinsic Pontine Glioma (DIPG), a type of brain tumor. It is being developed as a small molecule therapy for this indication. The drug is administered by convection-enhanced delivery directly to the tumor site.
Panobinostat Nanoparticle Formulation MTX110 targets histone deacetylases (HDACs), which are enzymes involved in gene expression regulation. By inhibiting HDACs, the drug aims to alter cancer cell behavior. This mechanism is relevant to its potential effect on Diffuse Intrinsic Pontine Glioma.
Panobinostat Nanoparticle Formulation MTX110 is being developed by Biodexa Pharmaceuticals plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol BDRX. Biodexa is conducting clinical research to evaluate the drug's safety and efficacy in patients.
Panobinostat Nanoparticle Formulation MTX110 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug has received Fast Track designation from the FDA, which may expedite its development and review process.
Panobinostat Nanoparticle Formulation MTX110 has one completed clinical trial, identified as NCT03566199. This Phase 1 study evaluated the drug in participants with newly-diagnosed Diffuse Intrinsic Pontine Glioma. The trial enrolled 7 patients in the United States and was not randomized or blinded.
Yes, Panobinostat Nanoparticle Formulation MTX110 is the same as MTX110. The drug is also known by this alternative name, which is used in clinical trial registries and scientific literature. Both names refer to the same investigational therapy for Diffuse Intrinsic Pontine Glioma.