By Chris Wack
Shuttle Pharmaceuticals has received positive written responses to questions submitted for a Type B pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration.
The company said that the FDA’s positive feedback and guidance on its Chemistry, Manufacturing and Controls, 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.
Ropidoxuridine is Shuttle’s lead candidate of radiation sensitizer for use in combination with radiation therapy to treat brain tumors, or 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.
Write to Chris Wack at [email protected]
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