Shuttle Pharma to Enroll Patients in Phase 2 Ropidoxuridine Glioblastoma Trial

On August 14, 2024, Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), also known as Shuttle Pharma, announced its progress in the Phase 2 clinical trial for Ropidoxuridine, a treatment candidate for glioblastoma. Glioblastoma is a severe brain malignancy with limited treatment options. Ropidoxuridine (IPdR) is designed to enhance the effectiveness of radiation therapy (RT), making it a potential breakthrough for patients with this aggressive cancer.

Shuttle Pharma has successfully initiated agreements with two of the six planned site locations for the trial, marking a significant step towards patient enrollment. The trial aims to address IDH wild-type, methylation negative glioblastoma, a subgroup with particularly poor prognosis. Current treatments for these patients primarily involve radiation therapy, yet survival rates remain dismally low, with over half succumbing to the disease within a year of diagnosis.

The Phase 2 trial will include 40 patients divided into two dosage groups: 20 patients will receive 1,200 mg/day of Ropidoxuridine, while the remaining 20 will receive 960 mg/day. The objective is to identify the optimal dose, after which an additional 14 patients will be treated with the determined optimal dosage. The trial will measure survival rates against historical data, with an estimated duration of 18 to 24 months.

Dr. Anatoly Dritschilo, Chairman and CEO of Shuttle Pharma, expressed optimism about collaborating with esteemed academic medical centers for this trial. He emphasized the potential impact of radiation sensitizers like Ropidoxuridine on improving cancer cure rates, extending patient survival, and enhancing the quality of life for glioblastoma patients.

The trial will eventually expand to six sites, all expected to begin patient treatments in the near future. Dr. Tyvin Rich, Shuttle Pharma's Chief Medical Officer and Professor Emeritus of Radiation Oncology at the University of Virginia School of Medicine, highlighted the strategic selection of universities and hospitals best suited to handle this specific patient group. This careful selection aims to expedite patient enrollment in the trial.

In the United States, approximately 800,000 cancer patients undergo radiation therapy annually, with about half receiving it for curative purposes. This delineates a significant market opportunity for radiation sensitizers like Ropidoxuridine, which could benefit around 400,000 patients treated with curative intent. This number is poised to grow by over 22% in the next five years.

Shuttle Pharma, founded in 2012 by Georgetown University Medical Center faculty, focuses on enhancing the outcomes of cancer patients undergoing radiation therapy. Their mission is to develop therapies that maximize RT effectiveness while minimizing its side effects, thereby aiming to boost cure rates, prolong survival, and improve the quality of life for cancer patients. The company explores the use of radiation sensitizers in primary treatments and in combination with surgery, chemotherapy, and immunotherapy, pursuing a comprehensive approach to cancer care.