Shuttle Pharma Doses First Patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
Shuttle Pharmaceuticals (Nasdaq: SHPH) has initiated patient dosing in its Phase 2 Clinical Trial of Ropidoxuridine, a radiation sensitizer for treating glioblastoma brain tumors. The trial involves 40 patients initially randomized into two dosage groups (1,200 mg/day and 960 mg/day), with plans to add 14 more patients once the optimal dose is determined. The study targets IDH wild-type, methylation negative glioblastoma patients, who currently have treatment options with radiation therapy. The trial is expected to complete in 18-24 months. Ropidoxuridine has received FDA Orphan Drug Designation, potentially providing marketing exclusivity upon approval.
Shuttle Pharmaceuticals (Nasdaq: SHPH) ha avviato la somministrazione ai pazienti nel suo studio clinico di Fase 2 riguardante Ropidoxuridina, un sensibilizzatore alla radiazione per il trattamento dei tumori cerebrali di glioblastoma. Lo studio coinvolge inizialmente 40 pazienti randomizzati in due gruppi di dosaggio (1.200 mg/giorno e 960 mg/giorno), con piani di aggiungere 14 pazienti in più una volta determinato il dosaggio ottimale. L'obiettivo dello studio è i pazienti con glioblastoma IDH wild-type, negativi alla metilazione, che attualmente hanno opzioni di trattamento con la terapia radiante. Si prevede che la sperimentazione si completi in 18-24 mesi. Ropidoxuridina ha ricevuto la Designazione di Farmaco Orfano da parte della FDA, con la possibilità di fornire esclusività di commercializzazione una volta approvato.
Shuttle Pharmaceuticals (Nasdaq: SHPH) ha iniciado la dosificación de pacientes en su ensayo clínico de Fase 2 de Ropidoxuridina, un sensibilizador a la radiación para tratar tumores cerebrales de glioblastoma. El ensayo involucra a 40 pacientes inicialmente aleatorizados en dos grupos de dosis (1,200 mg/día y 960 mg/día), con planes de agregar 14 pacientes más una vez que se determine la dosis óptima. El estudio se centra en pacientes con glioblastoma IDH wild-type, negativos a la metilación, quienes actualmente tienen opciones de tratamiento con terapia de radiación. Se espera que el ensayo se complete en 18-24 meses. Ropidoxuridina ha recibido la designación de medicamento huérfano por parte de la FDA, lo que potencialmente proporciona exclusividad de comercialización una vez aprobado.
샌들 제약 (Nasdaq: SHPH)는 로피독수리딘의 2상 임상 시험에서 환자 투약을 시작했습니다. 로피독수리딘은 뇌종양인 교모세포종 치료를 위한 방사선 감작제입니다. 이 시험은 초기 40명의 환자를 두 개의 용량 그룹(하루 1,200mg 및 하루 960mg)으로 무작위 배정하며, 최적의 용량이 결정되면 14명의 환자를 추가할 계획입니다. 이 연구는 IDH 와일드타입, 메틸화 음성 교모세포종 환자를 대상으로 하며, 현재 방사선 요법으로 치료 옵션을 가지고 있습니다. 이 시험은 18-24개월 이내에 완료될 것으로 예상됩니다. 로피독수리딘은 FDA에서 고아약 지정을 받았으며, 이는 승인 시 마케팅 독점권을 제공할 수 있습니다.
Shuttle Pharmaceuticals (Nasdaq: SHPH) a commencé l'administration aux patients dans son essai clinique de Phase 2 de Ropidoxuridine, un sensibilisateur aux radiations pour le traitement des tumeurs cérébrales de glioblastome. L'essai implique 40 patients initialement randomisés en deux groupes de dosage (1 200 mg/jour et 960 mg/jour), avec des plans pour ajouter 14 patients supplémentaires une fois la dose optimale déterminée. L'étude cible les patients atteints de glioblastome IDH wild-type, négatifs à la méthylation, qui ont actuellement des options de traitement avec la radiothérapie. L'essai devrait se terminer dans 18 à 24 mois. Ropidoxuridine a reçu la désignation de médicament orphelin de la FDA, fournissant potentiellement une exclusivité de commercialisation une fois approuvé.
Shuttle Pharmaceuticals (Nasdaq: SHPH) hat die Patientendosierung in seiner Phase-2-Studie zu Ropidoxuridin begonnen, einem Strahlensensibilisator zur Behandlung von Glioblastom-Hirntumoren. Die Studie umfasst zunächst 40 Patienten, die in zwei Dosierungsgruppen randomisiert wurden (1.200 mg/Tag und 960 mg/Tag), mit dem Plan, 14 weitere Patienten hinzuzufügen, sobald die optimale Dosis bestimmt ist. Die Studie zielt auf Patienten mit IDH Wild-Type und methylierungsnegativem Glioblastom ab, die derzeit Behandlungsmöglichkeiten mit Strahlentherapie haben. Es wird erwartet, dass die Studie in 18-24 Monaten abgeschlossen ist. Ropidoxuridin hat von der FDA die Zulassung als Orphan Drug erhalten, was potenziell eine Vermarktungsexklusivität nach Genehmigung bieten könnte.
- FDA Orphan Drug Designation received for Ropidoxuridine
- First three patients successfully dosed in Phase 2 trial
- Market opportunity includes 400,000 potential patients in US, expected to grow 22% in 5 years
- Treatment addresses an unmet medical need in aggressive brain tumors
- Trial completion timeline of 18-24 months indicates lengthy development process
- Current survival rate for target patient group is less than 12 months
- initial trial size of 40 patients with additional 14 patients pending optimal dose determination
Insights
The initiation of Phase 2 dosing for Ropidoxuridine marks a significant milestone in glioblastoma treatment development. The trial's design targeting IDH wild-type, methylation negative glioblastoma patients is particularly noteworthy, as this aggressive subtype currently has treatment options with poor survival rates. The dual-dose approach (1,200 mg/day vs 960 mg/day) with 40 initial patients, followed by an expansion cohort of 14 patients at the optimal dose, is methodologically sound for determining both safety and efficacy.
The market opportunity is substantial, with
GAITHERSBURG, Md., Oct. 29, 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 that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been successfully dosed.
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 with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma patients. This particular group of patients at this time only have radiation as the standard of care, with more than half of the patients surviving for less than 12 months after diagnosis. The Phase 2 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 dose allowing for the achievement of statistical significance with the end point being that of survival compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.
“The initiation of patient dosing in our Phase 2 trial of Ropidoxuridine for the treatment of patients with glioblastoma is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies,” commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. “The results of this trial will be important as Shuttle Pharma looks to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”
An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. 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
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