Shuttle Pharma Expands Enrollment for Phase 2 Glioblastoma Trial of Ropidoxuridine

GAITHERSBURG, Md., November 26, 2024 – Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a pharmaceutical company devoted to enhancing the outcomes for cancer patients undergoing radiation therapy, has announced the enrollment and initial dosing of its first patient at the UVA Cancer Center in the Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma treatment. UVA Cancer Center is one of six centers participating in this trial. Earlier, Shuttle Pharma disclosed that patients at the Miami Cancer Institute, part of Baptist Health South Florida, had also begun receiving doses.

The Phase 2 clinical trial involves 40 patients randomly assigned to two different doses of Ropidoxuridine (20 patients receiving 1,200 mg/day and 20 patients receiving 960 mg/day) to determine the optimal dosage. Once identified, an additional 14 patients will be included in the trial at this optimal dosage to ensure statistical significance, with overall survival as the primary endpoint compared to historical data. This trial focuses on an aggressive type of brain tumor known as IDH wild-type, methylation-negative glioblastoma. Currently, radiation remains the sole standard treatment for these patients, with more than half surviving less than a year post-diagnosis.

Ropidoxuridine (IPdR) is Shuttle Pharma's leading candidate as a radiation sensitizer, intended for use alongside radiation therapy to treat glioblastoma, a highly lethal brain cancer with no known cure. The FDA has granted Orphan Drug Designation to Ropidoxuridine, offering potential market exclusivity upon first approval for treating this disease.

In addition to the UVA Cancer Center and Miami Cancer Institute, the Phase 2 trial is being conducted at other esteemed institutions: Georgetown University Medical Center, John Theurer Cancer Center at Hackensack University Medical Center, and Allegheny Health Network (AHN) Cancer Institute.

Shuttle Pharma's Chairman and CEO, Dr. Anatoly Dritschilo, expressed his satisfaction with the trial's advancement, highlighting the significance of enrolling and dosing the first patient at UVA Cancer Center. He noted the strategic alignment with renowned cancer centers nationwide to treat patients with IDH wild-type, methylation-negative glioblastoma. Dr. Dritschilo emphasized the potential impact of radiation sensitizers in enhancing cancer cure rates, extending patient survival, and improving the quality of life for glioblastoma patients.

In the United States, approximately 800,000 cancer patients receive radiation therapy annually. According to the American Cancer Society and the American Society of Radiation Oncologists, about half of these therapies are for curative purposes, with the remainder being therapeutic. The market opportunity for radiation sensitizers is significant, targeting the 400,000 patients treated for curative purposes, with projections indicating a 22% increase in this number over the next five years.

For more details on the Phase 2 study (NCT06359379), visit www.clinicaltrials.gov.

About Shuttle Pharmaceuticals:

Established in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharmaceuticals is a specialty pharmaceutical company at the discovery and development stage. The company's mission is to enhance the outcomes for cancer patients treated with radiation therapy by developing therapies that maximize radiation effectiveness while minimizing its side effects. Recognizing the proven efficacy of radiation therapy in cancer treatment, Shuttle Pharma focuses on creating radiation sensitizers to boost 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.