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Shuttle Pharma Ready to Enroll Patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
GAITHERSBURG, Md., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development
About this update from Shuttle Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"GAITHERSBURG, Md., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today it has entered into agreements with two of the six site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma. Site initiation visits have been completed for two sites. The trial is now open to enroll patients in the clinical trial. Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease. The Phase 2 clinical trial will be conducted on patients with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma. Presently, radiation is the only approved standard of care for this particular group of patients, with more than half of the patients surviving for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dosage allowing for the achievement of statistical significance with the end point being that of survival as compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months. “We are pleased to be working with highly talented teams at academic medical centers on our Phase 2 trial of Ropidoxuridine for the treatment of patients with glioblastoma,” commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. “The results of this trial will be important to the cancer community as we look for ways to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.” Shuttle Pharma expects the Phase 2 clinical trial will be carried out at six site locatio...