What is a Phase I Clinical Trial?

Before introducing new medicines to the public, companies or hospitals must test experimental treatments very carefully through medical research studies known as clinical trials. This trial is known as a Phase I Clinical Trial, as this is the first time it has been tested in humans with medulloblastoma. Although, as of today, more than 20 patients with other forms of brain cancer have been safely treated with MTX110. The trial will be used to help determine how safe MTX110 is as a potential treatment for medulloblastoma.

What is being tested?

MTX110 is a solubilized formulation of a drug called Panobinostat, which is a class of drugs known as a histone deacetylase (HDAC) inhibitor. Panobinostat has previously been approved in a capsule form for treatment of another cancer, a blood cancer called multiple myeloma. However, scientists have shown that it may also be very effective in treating brain cancers, such as medulloblastoma. MTX110 needs to be injected via an Ommaya reservoir. This delivery method is a common, first line treatment for brain tumors so you may already have one. If not, you will need a surgery to place the reservoir system at the beginning of the trial. During the trial, every eligible patient will receive MTX110 and the Ommaya reservoir.

How many people will take part in the MTX110-101 trial?

The trial is designed to treat 5 patients.

What does MTX110-101 hope to achieve?

The MTX110-101 clinical trial aims to understand whether the experimental treatment, MTX110, is safe in treating patients with recurrent or progressed medulloblastoma.

Medulloblastoma Clinical Trials | MTX110-101

The MTX110-101 clinical trial is now open for enrolment for eligible patients in a research trial to determine if an experimental treatment, MTX110, is safe to treat medulloblastoma.

Medulloblastoma is a fast growing, cancerous tumor that typically forms in or around the fourth ventricle of the brain. It is the most common aggressive brain cancer in children although it can occur at any age. Its location, being so close to important structures of the brain, limits the use of standard treatment options. After initial surgery, the disease may return and often its location does not allow the surgeon to remove it completely without damaging the healthy brain tissue.

It is common for patients to participate in clinical trials which are used to investigate potential new therapies and develop future treatments.

Before you participate in the trial, you/or your child will be required to read a document which explains all the procedures and visits. You will also have to provide written consent to either participate or allow your child to participate. Depending on the age of your child, they may also need to consent. If you decide to participate, you or your child will undergo a number of assessments to determine eligibility.

If eligible for the clinical trial, you or your child may need a surgery to fit a special catheter typically called an Ommaya reservoir (unless you’ve already got one). The reservoir will be placed under the skin to allow MTX110 to be injected through a catheter, into the brain, to reach the area of the tumor. This treatment will be repeated four times a week for a total of 6 weeks.

As this is a clinical trial, additional assessments will be conducted by your treating physician, and they will explain everything to you in detail.

What is a Phase I Clinical Trial?

Before introducing new medicines to the public, companies or hospitals must test experimental treatments very carefully through medical research studies known as clinical trials. This trial is known as a Phase I Clinical Trial, as this is the first time it has been tested in humans with medulloblastoma. Although, as of today, more than 20 patients with other forms of brain cancer have been safely treated with MTX110. The trial will be used to help determine how safe MTX110 is as a potential treatment for medulloblastoma.
What is being tested?

MTX110 is a solubilized formulation of a drug called Panobinostat, which is a class of drugs known as a histone deacetylase (HDAC) inhibitor. Panobinostat has previously been approved in a capsule form for treatment of another cancer, a blood cancer called multiple myeloma. However, scientists have shown that it may also be very effective in treating brain cancers, such as medulloblastoma.

MTX110 needs to be injected via an Ommaya reservoir. This delivery method is a common, first line treatment for brain tumors so you may already have one. If not, you will need a surgery to place the reservoir system at the beginning of the trial.

During the trial, every eligible patient will receive MTX110 and the Ommaya reservoir.
How many people will take part in the MTX110-101 trial?

The trial is designed to treat 5 patients.
What does MTX110-101 hope to achieve?

The MTX110-101 clinical trial aims to understand whether the experimental treatment, MTX110, is safe in treating patients with recurrent or progressed medulloblastoma.

MTX110-101 Medulloblastoma Clinical Trial in 2023

Welcome to the

The trial is sponsored by the McGovern Medical School/UT Health and Children’s Memorial Hermann Hospital in Houston.

MTX110 is provided by Biodexa Pharmaceuticals.

Purpose of the MTX110-101 Trial

No trial procedures will occur without your consent.

What is involved in the MTX110-101 clinical trial?

Key inclusion/exclusion criteria

What is a Phase I Clinical Trial?

What is being tested?

How many people will take part in the MTX110-101 trial?

What does MTX110-101 hope to achieve?

Want to find out more?