Shuttle Pharma Completes Clinical Trial Site Enrollment for Phase 2 of Ropidoxuridine for Treatment of Patients with Glioblastoma
Shuttle Pharmaceuticals (Nasdaq: SHPH) has completed enrollment of six clinical trial sites for its Phase 2 study of Ropidoxuridine, a radiation sensitizer for treating glioblastoma. The trial sites include Georgetown University Medical Center, UNC Medical Center, UVA Cancer Center, John Theurer Cancer Center, Allegheny Health Network Cancer Institute, and Miami Cancer Institute. The study will randomize 40 patients into two dose groups (1,200 mg/day and 960 mg/day) to determine optimal dosing, followed by an additional 14 patients for survival endpoint comparison. The trial is expected to complete in 18-24 months. Ropidoxuridine has received FDA Orphan Drug Designation for brain tumor treatment.
Shuttle Pharmaceuticals (Nasdaq: SHPH) ha concluso l'arruolamento di sei siti di sperimentazione clinica per il suo studio di Fase 2 su Ropidoxuridina, un sensibilizzante per le radiazioni per il trattamento del glioblastoma. I siti di sperimentazione includono il Georgetown University Medical Center, l'UNC Medical Center, l'UVA Cancer Center, il John Theurer Cancer Center, l'Allegheny Health Network Cancer Institute e il Miami Cancer Institute. Lo studio randomizzerà 40 pazienti in due gruppi di dosaggio (1.200 mg/giorno e 960 mg/giorno) per determinare il dosaggio ottimale, seguito da ulteriori 14 pazienti per il confronto degli endpoint di sopravvivenza. Si prevede che la sperimentazione si concluda in 18-24 mesi. Ropidoxuridina ha ricevuto la designazione di Farmaco Orfano dalla FDA per il trattamento dei tumori cerebrali.
Shuttle Pharmaceuticals (Nasdaq: SHPH) ha completado el reclutamiento de seis sitios de ensayos clínicos para su estudio de Fase 2 sobre Ropidoxuridina, un sensibilizador de radiación para el tratamiento del glioblastoma. Los sitios de ensayo incluyen el Georgetown University Medical Center, el UNC Medical Center, el UVA Cancer Center, el John Theurer Cancer Center, el Allegheny Health Network Cancer Institute y el Miami Cancer Institute. El estudio aleatorizará a 40 pacientes en dos grupos de dosis (1,200 mg/día y 960 mg/día) para determinar la dosis óptima, seguido de otros 14 pacientes para la comparación de endpoints de supervivencia. Se espera que el ensayo finalice en 18-24 meses. Ropidoxuridina ha recibido la designación de Medicamento Huérfano por parte de la FDA para el tratamiento de tumores cerebrales.
셔틀 제약 (Nasdaq: SHPH)는 로피독수리디네의 2단계 임상 시험을 위한 6개 임상 시험 사이트의 등록을 완료했습니다. 이 방사선 감감제는 교모세포종 치료에 사용됩니다. 임상 시험 사이트에는 조지타운 대학교 의료 센터, UNC 메디컬 센터, UVA 암 센터, 존 투레르 암 센터, 알레게니 건강 네트워크 암 연구소, 그리고 마이애미 암 연구소가 포함됩니다. 이 연구는 40명의 환자를 두 개의 용량 그룹(1,200 mg/일 및 960 mg/일)으로 무작위 배정하여 최적의 용량을 결정하고, 이후 14명의 환자를 추가하여 생존 기준 비교를 진행할 예정입니다. 이 시험은 18-24개월 이내에 완료될 것으로 예상됩니다. 로피독수리디네는 뇌종양 치료를 위해 FDA의 오르판 약물 지정을 받았습니다.
Shuttle Pharmaceuticals (Nasdaq: SHPH) a terminé le recrutement de six sites d'essais cliniques pour son étude de phase 2 sur Ropidoxuridine, un sensibilisant aux radiations pour le traitement du glioblastome. Les sites d'étude incluent le Georgetown University Medical Center, le UNC Medical Center, le UVA Cancer Center, le John Theurer Cancer Center, l'Allegheny Health Network Cancer Institute et le Miami Cancer Institute. L'étude randomisera 40 patients en deux groupes de dose (1 200 mg/jour et 960 mg/jour) afin de déterminer la posologie optimale, suivie de 14 patients supplémentaires pour la comparaison des critères d'évaluation de la survie. L'essai devrait se terminer dans 18 à 24 mois. Ropidoxuridine a reçu la désignation de médicament orphelin par la FDA pour le traitement des tumeurs cérébrales.
Shuttle Pharmaceuticals (Nasdaq: SHPH) hat die Einschreibung von sechs klinischen Prüfzentren für seine Phase-2-Studie zu Ropidoxuridin, einem Strahlensensibilisator zur Behandlung von Glioblastomen, abgeschlossen. Die Studienstandorte umfassen das Georgetown University Medical Center, das UNC Medical Center, das UVA Cancer Center, das John Theurer Cancer Center, das Allegheny Health Network Cancer Institute und das Miami Cancer Institute. In der Studie werden 40 Patienten randomisiert in zwei Dosisgruppen (1.200 mg/Tag und 960 mg/Tag) eingeteilt, um die optimale Dosierung zu bestimmen, gefolgt von weiteren 14 Patienten zum Vergleich der Überlebensendpunkte. Die Studie wird voraussichtlich in 18-24 Monaten abgeschlossen sein. Ropidoxuridin hat von der FDA die Orphan-Drug-Bezeichnung zur Behandlung von Hirntumoren erhalten.
- Completed enrollment of all six planned clinical trial sites
- FDA Orphan Drug Designation secured, providing potential marketing exclusivity
- Patient screening and enrollment process has begun
- Large market opportunity with 400,000 potential patients annually in the US
- Trial completion timeline of 18-24 months indicates long wait for results
- Current treatment outcomes show over 50% of patients survive less than 12 months
Insights
The completion of site enrollment for Ropidoxuridine's Phase 2 trial marks a significant milestone in addressing an urgent unmet need in glioblastoma treatment. The trial's design targeting IDH wild-type, methylation negative glioblastoma patients is particularly noteworthy, as this aggressive form has poor survival rates of
The enrollment of 40 patients across six prestigious cancer centers, with an additional 14 patients planned for the optimal dosage group, provides a robust framework for evaluating efficacy. The potential market is substantial, with 400,000 radiation therapy patients annually who could benefit from radiation sensitizers. The FDA's Orphan Drug Designation adds significant value through potential market exclusivity.
The 18-24 month timeline for trial completion is reasonable given the survival endpoints being measured. The two-dose randomization approach (960mg/day vs 1,200mg/day) will help establish optimal dosing while gathering important survival data compared to historical controls.
GAITHERSBURG, Md., Oct. 28, 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 finalized agreements with all six of the planned site enrollment locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma following the entry into agreements with Georgetown University Medical Center and UNC Medical Center. The Company previously entered agreements 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. Patients are currently undergoing screening for enrollment in 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 has received Orphan Drug Designation from the FDA for IPdR, providing potential marketing exclusivity upon first FDA approval for treatment of the disease.
“We have successfully engaged all six of the planned clinical trial site locations to administer the Phase 2 clinical trial of Ropidoxuridine,” commented Shuttle Pharma's CEO, Anatoly Dritschilo, M.D. “All six locations are nationally recognized cancer centers that are most likely to treat IDH wild-type, methylation negative glioblastoma patients, the target of the clinical trial. Patients are currently being evaluated for enrollment, having signed consents for treatment, and are now in the process of being screened.”
The Phase 2 clinical trial has begun enrolling patients with aggressive, IDH wild-type, methylation negative glioblastomas. Presently, radiation is the standard of care for this particular group of patients, but outcome studies have shown that more than half of the patients live for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will randomize 40 patients into two different dose groups (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose, which will then be continued to add 14 patients on the optimal dosage to reach the survival end-point for comparison to historical controls. The Company expects the trial to be completed over the next 18 to 24 months.
Dr. Dritschilo continued, “An estimated 800,000 patients in the U.S. are treated with radiation therapy annually. According to the American Cancer Society and the American Society of Radiation Oncologists, about
More information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.
About Shuttle Pharmaceuticals
Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com.
Safe Harbor Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning the development of our company. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ended December 31, 2023, as amended, filed with the SEC on September 4, 2024, as well other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Shuttle Pharmaceuticals
Anatoly Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com
Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com
FAQ
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