Core Viewpoint - Shuttle Pharmaceuticals is advancing its Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment, with the first patient enrolled at UVA Cancer Center, aiming to improve outcomes for cancer patients undergoing radiation therapy [1][5]. Company Overview - Shuttle Pharmaceuticals is a discovery and development stage specialty pharmaceutical company founded in 2012, focused on enhancing cancer treatment outcomes through radiation sensitizers [7]. - The company's mission is to improve the lives of cancer patients by maximizing the effectiveness of radiation therapy while minimizing side effects [7]. Clinical Trial Details - The Phase 2 trial will initially involve 40 patients randomized into two dosing groups (20 patients at 1,200 mg/day and 20 patients at 960 mg/day) to identify the optimal dose [2]. - Following the determination of the optimal dose, an additional 14 patients will be added to achieve statistical significance, with survival as the primary endpoint compared to historical controls [2]. - The trial targets patients with IDH wild-type, methylation negative glioblastoma, a type of brain tumor with a poor prognosis, where standard care is currently limited to radiation therapy [2]. Market Opportunity - Approximately 800,000 patients in the US receive radiation therapy for cancer annually, with about 50% treated for curative purposes, representing a significant market opportunity for radiation sensitizers [5]. - The number of patients treated for curative purposes is expected to grow by more than 22% over the next five years, indicating a rising demand for effective treatments [5]. Regulatory Status - Ropidoxuridine has received Orphan Drug Designation from the FDA, which may provide marketing exclusivity upon first approval for glioblastoma treatment [3]. Trial Locations - The Phase 2 trial is being conducted at multiple prestigious cancer centers, including UVA Cancer Center, Georgetown University Medical Center, and Miami Cancer Institute, among others [4].
Shuttle Pharma Expands Patient Enrollment for Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma as UVA Cancer Center Doses Its First Patient