Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has expanded its Phase 2 clinical trial for Ropidoxuridine, a radiation sensitizer, in patients with glioblastoma by adding two more clinical trial sites. This brings the total to four active sites out of the six planned, including UVA Cancer Center, John Theurer Cancer Center, Allegheny Health Network Cancer Institute, and Miami Cancer Institute. The trial aims to improve outcomes for patients with IDH wild-type, methylation negative glioblastoma, an aggressive form of brain cancer.
Targeting Aggressive Glioblastoma Subtype
The Phase 2 trial specifically targets patients with IDH wild-type, methylation negative glioblastoma. This subgroup represents a particularly challenging population, as they often have limited response to existing treatments and a poor prognosis, with more than half surviving less than 12 months after diagnosis. By focusing on this specific subtype, Shuttle Pharma aims to address a significant unmet medical need.
Ropidoxuridine as Radiation Sensitizer
Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate, designed to enhance the effectiveness of radiation therapy (RT) in treating brain tumors. As a radiation sensitizer, Ropidoxuridine aims to make cancer cells more susceptible to radiation, potentially increasing cure rates and prolonging patient survival. The drug has been granted Orphan Drug Designation by the FDA, which could provide market exclusivity upon approval.
Trial Design and Enrollment
The Phase 2 clinical trial will initially enroll 40 patients, randomized into two different dosage arms (1,200 mg/day and 960 mg/day) to determine the optimal dose. Following the dose optimization phase, an additional 14 patients will be added to the optimal dosage arm to achieve statistical significance, using survival compared to historical controls as the primary endpoint. The company anticipates the trial will take 18 to 24 months to complete.
Market Opportunity and Radiation Therapy
Radiation therapy is a common cancer treatment, with an estimated 800,000 patients in the US receiving it annually. Approximately 50% of these patients are treated for curative purposes, representing the primary market opportunity for radiation sensitizers like Ropidoxuridine. This market is projected to grow by over 22% in the next five years, according to the American Cancer Society and the American Society of Radiation Oncologists.
Management Commentary
"I am pleased to report yet another key milestone in the advancement of our Phase 2 clinical trial for the treatment of patients with glioblastoma, having successfully onboarded two additional nationally recognized cancer centers," commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. "Each of the four initial locations have completed site initiation visits and are fully ready to begin treating patients, with the final two sites set to come on board in the coming weeks."
