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Shuttle Pharma Hits Patient Enrollment Milestone for Phase 2 Ropidoxuridine Clinical Trial

Ropidoxuridine is Shuttle Pharma’s lead candidate radiation sensitizer for use in combination with radiation therapy to treat Glioblastoma (brain tumors), a deadly brain malignancy with no known cure.

Shuttle Pharmaceuticals (NASDAQ: SHPH), a discovery and development-stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), announced that it achieved a 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of 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 has 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 radiation therapy to treat brain tumors (glioblastoma), a deadly brain malignancy with no known cure. The company previously received an Orphan Drug Designation from the FDA, which provides potential marketing exclusivity upon obtaining FDA approval for the 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.

Anatoly Dritschilo, M.D., Shuttle Pharmaceuticals CEO and Chairman, commented:

“Enrollment into the trial is ahead of our expectations. 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, which is expected to grow by more than 22% over the next five years.

More information about the Shuttle Pharma Phase 2 Ropidoxuridine Clinical Trial (NCT06359379) can be found at the website clinicaltrials.gov.


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