Frequently asked questions

There is a specific set of eligibility criteria you must meet prior to taking part in the trial. You need to contact one of the participating sites to determine if you can be screened to take part in the clinical trial. Contact details can be found here.

Biodexa Pharmaceuticals will pay for any research related expenses, this includes the cost of pumps, experimental drugs, hospitalizations during active infusion and research specific MRIs. Biodexa Pharmaceuticals will also pay for your accommodation, if required, in addition to reasonable weekly traveling costs to the site.

You and/or your insurance company will have to pay for any costs that are considered regular medical standard of care for treatment of glioblastoma. This includes, but may not be limited to, an initial biopsy for diagnosis confirmation and regular routine MRIs. Since these procedures are typically offered to patients with glioblastoma, and thus considered standard practice, you will be responsible for any co-pays/co-insurance that you usually have when seeking medical treatment.

At present the trial is only open to patients from the United States.

The investigator at the study site will assess your eligibility against the clinical trial protocol. This is to determine if you are eligible to be entered into the trial. 

All patients which are eligible will receive MTX110, however only a certain number will have an optional surgery to reposition the catheter. Whether you are offered the second surgery will depend on how many patients were treated before you and whether you are suitable to have a repositioning surgery based on the doctors' and surgeon's opinion. Before entering the trial, the investigator will be able to let you know how many patients have been treated and which treatment you will receive.

You may experience side effects if you take part in this study. Before entering the trial you will need to read a document which outlines the details of the clinical trial including the risks associated with the study drug, the surgery and the procedures you will undergo. If you have any questions, you will have an opportunity to speak to the doctor. You will not undergo any procedure until you have read and signed the document.

You will read and sign a document which describes the trial in detail. You will not undergo any procedure until you have read and signed the document. You will then undergo a number of procedures to determine whether you are eligible for the study. This includes blood tests, scans and some clinical assessments. If eligible, you will undergo a surgery to insert the catheter and pump. You will then need to return weekly for assessments and pump refills of MTX110. Depending on which group you're in, you may have a second surgery to move the inserted catheter. You will have regular MRI scans to assess your disease status.

Most chemotherapy drugs, delivered via tablets (orally) or intravenously, do not get into the brain in a sufficient quantity to have an impact on the tumor. This makes them difficult to use for treatment of brain tumors. This is because the brain has a natural barrier between blood vessels and brain tissue. It’s called the ‘blood brain barrier’ and it prevents drugs administered by these routes from entering the brain and the tumor. Even if you tried increasing the dose, the amount needed to enter the brain could be very toxic to your body. This would naturally counteract the potential benefits of such a drug. 

Since MTX110 has been specially designed as a liquid solution, it can be delivered using a technique called convection-enhanced delivery (CED). 

Convection enhanced delivery (CED) is a method used to deliver drugs directly into a tumor. For this study, it is achieved by undergoing a surgery where a catheter will be implanted into your brain via a very precise technique called stereotactic surgery. This catheter will be positioned under the skin and will be connected to a pump that the surgeon will place under the skin in your stomach area. MTX110 is then administered slowly, pumped drop by drop directly into the center of the tumor. 

As the catheter is placed directly into the center of the tumor, the drug does not need to travel through the ‘blood brain barrier'. Therefore, the amount of drug delivered to the tumor is significantly more when compared to taking a drug orally or a different method. As the drug is only being delivered directly to the site of the tumor and does not interact with other parts of the body, you avoid the higher and potentially more toxic doses that would be needed when taken orally.