Shuttle Pharmaceuticals Holdings, Inc. (SHPH) has announced the expansion of its Phase 2 clinical trial for Ropidoxuridine, a novel radiation sensitizer, in the treatment of glioblastoma. The first patient has been dosed at the UVA Cancer Center, marking a significant step in the trial's progression across six cancer centers.
The Phase 2 trial (NCT06359379) is designed to evaluate the efficacy and safety of Ropidoxuridine in combination with radiation therapy for patients with IDH wild-type, methylation-negative glioblastoma. This patient population currently has limited treatment options, with radiation therapy being the standard of care. The trial will initially enroll 40 patients, randomized into two dose groups: 20 patients receiving 1,200 mg/day and 20 patients receiving 960 mg/day. Following the initial phase, an additional 14 patients will be added to the trial at the optimal dose, determined from the first cohort.
Rationale for Ropidoxuridine
Glioblastoma remains a formidable challenge in oncology, characterized by its aggressive nature and poor prognosis. According to the National Brain Tumor Society, approximately 10,000 Americans are affected each year, with a survival rate of only 6.9%. Current treatments often fail to provide long-term remission, underscoring the urgent need for innovative therapeutic strategies.
Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate, designed to enhance the effectiveness of radiation therapy. By acting as a radiation sensitizer, Ropidoxuridine aims to increase cancer cure rates, prolong patient survival, and improve the quality of life for patients with glioblastoma. The FDA has granted Ropidoxuridine Orphan Drug Designation, which could provide marketing exclusivity upon approval.
Trial Design and Endpoints
The Phase 2 trial's primary endpoint is overall survival compared to historical controls. Secondary endpoints include assessing the safety and tolerability of Ropidoxuridine in combination with radiation therapy. The trial is being conducted at multiple nationally recognized cancer centers, including Georgetown University Medical Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, in addition to UVA Cancer Center.
Management Commentary
"I am pleased with the progress being made to advance our Phase 2 trial of Ropidoxuridine for the treatment of patients with glioblastoma with the addition of the first patient being dosed at UVA Cancer Center," said Anatoly Dritschilo, M.D., Chairman and CEO of Shuttle Pharma. "We have strategically aligned the trial with nationally recognized cancer centers across a variety of regions to treat patients with IDH wild-type, methylation negative glioblastoma, the target of the clinical trial. I look forward to the continued advancement of the trial as we look to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma."
Market Opportunity
Radiation therapy is a common treatment modality for cancer, with an estimated 800,000 patients in the US receiving it annually. Approximately 50% of these patients are treated for curative purposes, representing a significant market opportunity for radiation sensitizers like Ropidoxuridine. This market is expected to grow by more than 22% over the next five years, driven by the increasing incidence of cancer and advancements in radiation therapy techniques.
