Shuttle Pharma Begins Phase 2 Trial of Ropidoxuridine for Glioblastoma

GAITHERSBURG, Md., Oct. 29, 2024 — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a company specializing in developing therapies to enhance the outcomes for cancer patients undergoing radiation therapy (RT), has announced a significant milestone. The first trio of patients in its Phase 2 clinical trial for Ropidoxuridine, designed to treat glioblastoma, has received their initial doses. Glioblastoma is an aggressive and fatal brain cancer with no known cure.

Ropidoxuridine (IPdR), Shuttle Pharma's leading radiation sensitizer, is intended to be used alongside RT to target brain tumors. The company has been granted Orphan Drug Designation by the FDA, which offers potential market exclusivity following the drug’s first FDA approval for this disease.

The Phase 2 clinical trial focuses on patients with the most aggressive forms of glioblastoma – IDH wild-type and methylation negative. These patients currently only receive radiation therapy as the standard treatment, and more than half survive less than a year after diagnosis. This trial will initially involve 40 patients, divided into two groups receiving different doses (20 patients at 1,200 mg/day and 20 patients at 960 mg/day) to determine the optimal dosage. Once identified, an additional 14 patients will be treated with the optimal dose to achieve statistical significance. The primary endpoint of the study is to measure survival rates against historical data. The trial is anticipated to conclude within 18 to 24 months.

Dr. Anatoly Dritschilo, Chairman and CEO of Shuttle Pharma, emphasized the importance of this development, stating, “The initiation of patient dosing in our Phase 2 trial of Ropidoxuridine for glioblastoma is a substantial milestone for both Shuttle Pharma and the numerous patients with brain tumors who lack effective treatment options. The outcomes of this trial will be pivotal as Shuttle Pharma aims to use radiation sensitizers to enhance cancer cure rates, extend patient survival, and improve the quality of life for those battling glioblastoma.”

In the United States, approximately 800,000 cancer patients receive radiation therapy each year. According to data from the American Cancer Society and the American Society of Radiation Oncologists, about half of these treatments are for curative purposes, while the rest are for therapeutic care. The potential market for radiation sensitizers includes the 400,000 patients treated for curative purposes, with expectations of a 22% increase in this number over the next five years.

About Shuttle Pharmaceuticals

Established in 2012 by faculty members from Georgetown University Medical Center, Shuttle Pharmaceuticals is dedicated to discovering and developing specialty pharmaceuticals to improve outcomes for cancer patients treated with radiation therapy. Their mission is to enhance patients' lives by creating therapies that maximize RT's effectiveness while reducing its side effects. Although RT is a proven cancer treatment modality, Shuttle Pharma aims to increase cure rates, extend survival times, and improve quality of life through the development of radiation sensitizers, either as primary treatments or in combination with surgery, chemotherapy, and immunotherapy.

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