Shuttle Pharma Completes Phase 2 Site Enrollment for Glioblastoma Treatment

Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), commonly referred to as Shuttle Pharma, has announced the completion of agreements with six clinical trial sites for the Phase 2 trial of their leading candidate, Ropidoxuridine. This drug is a radiation sensitizer aimed at increasing the effectiveness of radiation therapy (RT) in treating glioblastoma, a highly malignant brain tumor with no known cure. The recent agreements include Georgetown University Medical Center and UNC Medical Center, adding to previous partnerships with 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.

Ropidoxuridine (IPdR) is designed to enhance the impact of radiation therapy on glioblastoma, a condition recognized for its severity and poor prognosis. Shuttle Pharma has received Orphan Drug Designation from the FDA for this candidate, potentially offering marketing exclusivity following the first FDA approval for treatment.

According to Dr. Anatoly Dritschilo, CEO of Shuttle Pharma, the company has successfully engaged six prominent cancer centers to conduct the Phase 2 trial. These centers are selected for their capability to treat patients with IDH wild-type, methylation negative glioblastoma, the specific focus of this trial. Patient screening is currently underway.

The trial aims to enroll patients with aggressive forms of glioblastoma. Current standard care involves radiation, but studies reveal that over half of these patients survive less than a year post-diagnosis. Shuttle Pharma’s trial will include 40 participants, divided into two dosage groups (20 receiving 1,200 mg/day and 20 receiving 960 mg/day). Upon determining the optimal dose, an additional 14 patients will receive this dosage to evaluate survival outcomes compared to historical data. The trial is expected to conclude within 18 to 24 months.

Dr. Dritschilo highlighted that approximately 800,000 patients in the U.S. receive radiation therapy annually, with about half undergoing treatment with curative intent, according to the American Cancer Society and the American Society of Radiation Oncologists. The market potential for radiation sensitizers like Ropidoxuridine lies with the 400,000 patients treated with the goal of curing cancer. The results from this trial are anticipated to be significant for the medical community, potentially offering new methods to enhance cancer cure rates, extend patient survival, and improve quality of life for those battling glioblastoma.

Founded in 2012 by faculty members of Georgetown University Medical Center, Shuttle Pharma’s mission is to enhance the effectiveness of radiation therapy while minimizing its side effects. The company focuses on developing therapies that improve outcomes for cancer patients treated with RT. By creating radiation sensitizers, Shuttle Pharma aims to increase cure rates, prolong survival, and improve the quality of life for cancer patients, whether used alone or alongside surgery, chemotherapy, and immunotherapy.