Shuttle Pharmaceuticals approved by FDA for Phase 2 trial of Ropidoxuridine

Shuttle Pharmaceuticals announced they have received the ‘Safe to Proceed’ letter from the U.S. FDA for the company’s investigational new drug application for its Phase II study of Ropidoxuridine as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the Phase II study. Shuttle Pharma is currently finalizing site enrollment with ‘first patient, first dose’ expected in the coming months. Ropidoxuridine is Shuttle Pharma’s lead radiation sensitizer candidate for use in combination with radiation therapy to treat glioblastoma, a deadly malignancy of the brain with no known cure.