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), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the second quarter ended June 30, 2024.
Shuttle Pharma’s recent highlights include the following:
- Enrollment of patients in the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma has recently opened following the entry of agreements with two site locations to administer the 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 Pharma expects the Phase 2 clinical trial will be carried out at six site locations, with two sites now ready to start treating patients and all sites anticipated to be treating patients in the coming months.
- Shuttle Pharma has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.
“We achieved a significant milestone recently with the commencement of our Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma now officially underway and ready to enroll patients,” stated Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “To date, we have entered into agreements with two of the planned six site locations with an additional four sites set to come on board in September. The two initial sites have completed site initiation visits and are fully ready to begin treating patients. The results of this Phase 2 clinical trial will determine clinical efficacy of Ropidoxuridine as a radiation sensitizer with the goal of increasing cancer cure rates, prolonging patient survival, and improving the quality of life for patients suffering from glioblastoma.”
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, then an additional 14 patients will be enrolled 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.
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