Phase 1 Trial Will Analyze a Direct-to-Brain Drug for Recurrent Glioblastoma Treatment

The first patient was enrolled in a phase 1 trial of MTX110, a novel drug being tested for the treatment of recurrent glioblastoma (an aggressive type of brain cancer), according to Midatech Pharma, PLC, the manufacturer of the drug.

The goal of the phase 1 trial, which is named MAGIC-G1, is to determine the optimal dose of MTX110, as well as the safety and efficacy of convection enhanced delivery, which is a method of delivering drugs directly to the brain. There will be two groups in the study: one will receive MTX110 alone, while the other will receive MTX110 plus lomustine, a chemotherapy agent commonly used to treat brain tumors and other types of cancer.

Researchers are currently enrolling patients on the trial, which will take place at Baptist MD Anderson Cancer Center in Jacksonville, Florida and Duke University Hospital in Durham, North Carolina. To be eligible, patients must have recurrent glioblastoma, be healthy enough to undergo anesthesia and have an estimated life expectancy of three months or longer.

The main goal of the trial is to determine the frequency and nature of side effects — including serious side effects and those that lead to a decrease in the dose of MTX110. From that data, researchers will determine the recommended dose to be used in phase 2 of the trial.

The research team will also analyze overall survival (time from treatment until death from any cause) over a 12-month period; progression-free survival (time from treatment until disease gets worse) over a six-month period; and best overall response rate (percentage of patients whose cancer shrinks or disappears as a result of treatment) over six months.

“(Recurrent glioblastoma) is a devastating and incurable cancer marked by short survival rates and universal recurrence. A start of recruitment into the MAGIC-G1 study marks a significant step towards developing a potential new treatment paradigm for patients with this devastating disease that currently has limited effective treatment options,” Dr. Dmitry Zamoryakhin, chief scientific officer at Midatech said in a company-issued press release.

The researchers plan on completing the trial on Sept. 30, 2024.

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