Shuttle Pharma Reaches Milestone in Patient Enrollment for Phase 2 Trial of Ropidoxuridine for Treatment of Patients With Glioblastoma

Shuttle Pharmaceuticals Holdings, Inc. recently announced it has achieved 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma.

The Phase 2 trial design is to initially randomize 40 patients into two different dose levels, with 20 patients receiving 1,200 mg/day and 20 patients receiving 960 mg/day, to determine an optimal dose for use in glioblastoma patients. Once the optimal dose is identified, 14 additional patients will be enrolled at the optimal dose to reach statistical significance with the end-point demonstrating survival as compared to historical controls. The Phase 2 clinical trial is being conducted on patients presenting with the most aggressive form of brain tumors– IDH wild-type, methylation negative glioblastoma. This cohort of patients currently only have radiation as the standard of care, with less than half of the patients surviving beyond 12 months after diagnosis.

Ropidoxuridine (IPdR) is Shuttle Pharma’s lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle Pharma previously received Orphan Drug Designation from the FDA, providing Shuttle Pharma with potential marketing exclusivity upon obtaining FDA approval for treatment of this disease.

The Phase 2 trial is conducted at Georgetown University Medical Center, Allegheny Health Network (AHN) Cancer Institute, UNC Medical Center, the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, and Miami Cancer Institute, part of Baptist Health South Florida.

“Enrollment into the trial is ahead of our expectations,” commented Shuttle Pharma’s CEO and Chairman, Anatoly Dritschilo, MD. “I am grateful to the teams at each of these nationally recognized cancer centers for their participation in the trial as we look to develop radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”

An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for palliative therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected to grow by more than 22% over the next five years.

More information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.

Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, visit www.shuttlepharma.com.