Clinical Trials

Phase 2 Clinical Trial for Ropidoxuridine

We are currently conducting a Phase 2 clinical trial of Ropidoxuridine with the following medical centers:

• Georgetown University Medical Center
• UNC Medical Center
• UVA Cancer Center
• John Theurer Cancer Center at Hackensack University Medical Center
• Allegheny Health Network (AHN) Cancer Institute
• Miami Cancer Institute, part of Baptist Health South Florida

Study Design

The Phase 2 trial will enroll 40 patients, randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose based on efficacy and patient safety. Once the optimal dose is determined, an additional 14 patients will be enrolled on the trial at the optimal dose to reach statistical significance with the survival end-point as compared to historical controls.

The Phase 2 clinical trial will be conducted on patients presenting with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma patients. This cohort of patients is currently treated with radiation therapy only as the standard of care, with fewer than half of the patients surviving 12 months after diagnosis.

More information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.