On September 25, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported receipt of written responses to questions submitted for a Type B pre-Investigational New Drug Application (PIND) meeting with the U.S. Food and Drug Administration (FDA) (Press release, Shuttle Pharmaceuticals, SEP 25, 2023, View Source [SID1234635393]). The FDA’s positive feedback and guidance on the Company’s Chemistry, Manufacturing, and Controls (CMC) and clinical protocol design for Ropidoxuridine provides a pathway to IND application submission in the fourth quarter of 2023 to initiate the Phase 2 clinical trial.

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"The FDA’s written responses provide clarification and guidance on key aspects to our Phase 2 clinical design and CMC protocols, paving the way to Shuttle’s clinical development of Ropidoxuridine as a radiation sensitizer for treating glioblastoma," commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D.

Ropidoxuridine (IPdR) is Shuttle’s lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.