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Shuttle Pharma FDA Orphan-Drug Nears Patient Enrollment Milestone for Phase 2 Clinical Trial
GlobeNewswire News Roomยท 2025-05-08 20:01
Core Insights - Shuttle Pharmaceuticals is advancing its Phase 2 clinical trial for Ropidoxuridine, targeting glioblastoma patients, with nearly 50% enrollment achieved and positive early results regarding drug tolerance [1][2][3] - The company aims to finalize enrollment by the end of 2025, with data readout expected in 2026 [1][3] Company Overview - Shuttle Pharmaceuticals is a specialty pharmaceutical company founded in 2012, focused on enhancing outcomes for cancer patients undergoing radiation therapy [8] - The company's mission is to develop therapies that maximize the effectiveness of radiation therapy while minimizing side effects [8] Clinical Trial Details - The Phase 2 trial involves randomizing 40 patients into two dosage groups (1,200 mg/day and 960 mg/day) to identify the optimal dose for glioblastoma treatment [3] - Following the identification of the optimal dose, an additional 14 patients will be enrolled to achieve statistical significance in survival outcomes compared to historical controls [3] Market Opportunity - Approximately 800,000 patients in the US receive radiation therapy annually, with 50% treated for curative purposes, representing a significant market for radiation sensitizers [6] - The market for radiation sensitizers is expected to grow by over 22% in the next five years, driven by the 400,000 patients treated for curative purposes [6] Industry Impact - The trial is seen as critical for the radiation therapy industry, aiming to leverage radiation sensitizers to improve cancer cure rates and patient quality of life [5]