The Phase II trial will enrol glioblastoma patients with isocitrate dehydrogenase (IDH) wild-type, methylation-negative tumours. Credit: Owlie Productions/Shutterstock.

Shuttle Pharmaceuticals (Shuttle Pharma) has dosed the first three participants in a Phase II trial of its lead therapy, Ropidoxuridine, aimed at treating glioblastoma, a malignancy of the brain.

A radiation sensitiser, Ropidoxuridine is designed to be used alongside radiation therapy (RT) to treat the condition.

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The trial will enrol patients with isocitrate dehydrogenase (IDH) wild-type, methylation-negative glioblastoma.

It will initially involve 40 patients, who will be randomised into two groups to receive different dosages of Ropidoxuridine, 1,200mg/day and 960mg/day, to identify the optimal dose.

An additional 14 patients will then be treated with an optimal dosage of the therapy.

The primary endpoint of the trial is to assess survival following Ropidoxuridine, compared to historical controls.

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Shuttle Pharmaceuticals anticipates that the trial will last for 18 to 24 months.

The company also concluded agreements with six enrolment sites for this trial, with the recent addition of Georgetown University Medical Center and UNC Medical Center in the US.

Shuttle previously signed deals with UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute.

Shuttle Pharmaceuticals chairman and CEO Anatoly Dritschilo said: “The initiation of patient dosing in our Phase II trial of Ropidoxuridine for the treatment of patients with glioblastoma is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumours who currently lack effective therapies.

“The results of this trial will be important as Shuttle Pharma looks to leverage radiation sensitisers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”