Shuttle Pharma Expands Phase 2 Ropidoxuridine Trial Enrollment for Glioblastoma

GAITHERSBURG, Md., Sept. 16, 2024 – Shuttle Pharmaceuticals Holdings, Inc., a specialty pharmaceutical company listed on Nasdaq under the ticker SHPH, has made significant progress in its Phase 2 clinical trial for the treatment of glioblastoma with its leading candidate, Ropidoxuridine. The company has recently established agreements with two more sites, bringing the total to four out of the planned six trial locations that are now ready to enroll patients. These sites include UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida.

Anatoly Dritschilo, M.D., Chairman and CEO of Shuttle Pharma, expressed satisfaction over achieving this milestone, noting that the successful onboarding of these nationally recognized cancer centers marks an important step in advancing the clinical trial. He mentioned that the final two sites are expected to join in the coming weeks. These sites have been carefully selected for their potential to treat patients with IDH wild-type, methylation-negative glioblastoma, which is the primary focus of the trial. This targeted approach aims to expedite patient enrollment for the study.

Ropidoxuridine (IPdR) is Shuttle Pharma’s foremost radiation sensitizer designed to be used in conjunction with radiation therapy (RT) for treating glioblastoma, a severe and incurable brain cancer. The company has received Orphan Drug Designation from the FDA, which could provide market exclusivity upon approval. The Phase 2 trial aims to enroll patients with the aggressive form of glioblastoma. Currently, RT is the only approved standard of care for these patients, and the median survival rate is less than 12 months post-diagnosis.

The Phase 2 trial will initially include 40 patients who will be randomly assigned to one of two dosage groups: 20 patients at 1,200 mg/day and 20 patients at 960 mg/day, to determine the optimal dose. After identifying the optimal dose, an additional 14 patients will be treated at this dosage to achieve statistical significance. The end goal is to compare the survival rates of these patients against historical controls. The trial is expected to be completed within 18 to 24 months.

In the United States, approximately 800,000 cancer patients undergo radiation therapy annually. According to the American Cancer Society and the American Society of Radiation Oncologists, around 50% of these treatments are for curative purposes, with the remainder being therapeutic. The market for radiation sensitizers is substantial, encompassing the 400,000 patients treated for curative purposes, a number that is projected to grow by over 22% in the next five years.

For more details about the Phase 2 study, identified as NCT06359379, individuals can visit clinicaltrials.gov.

Shuttle Pharmaceuticals, founded in 2012 by Georgetown University Medical Center faculty members, is dedicated to enhancing cancer treatment outcomes, particularly for those receiving radiation therapy. The company focuses on developing therapies that increase the efficacy of RT while minimizing its side effects. Shuttle Pharma aims to improve patient survival rates and quality of life through radiation sensitizers, whether used alone or in combination with surgery, chemotherapy, and immunotherapy. For further information, please visit their website at shuttlepharma.com.