Shuttle Pharma Ready to Enroll Patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has announced readiness to enroll patients in a Phase 2 clinical trial of Ropidoxuridine for treating glioblastoma. The trial, focusing on IDH wild-type, methylation negative glioblastoma patients, will initially involve 40 patients randomized into two dosage groups. An additional 14 patients will be added once the optimal dose is determined. The study aims to improve survival rates compared to historical controls.
Ropidoxuridine, Shuttle Pharma's lead radiation sensitizer, has received Orphan Drug Designation from the FDA. The trial is expected to be completed in 18 to 24 months across six site locations. This study is important for the cancer community, potentially increasing cure rates and improving patient outcomes for this aggressive brain tumor.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ha annunciato la prontezza ad arruolare pazienti in un trial clinico di fase 2 per il Ropidoxuridina nel trattamento del glioblastoma. Lo studio, che si concentra sui pazienti con glioblastoma wild-type IDH e negativi alla metilazione, coinvolgerà inizialmente 40 pazienti randomizzati in due gruppi di dosaggio. Un ulteriore 14 pazienti saranno aggiunti una volta determinata la dose ottimale. L'obiettivo dello studio è migliorare i tassi di sopravvivenza rispetto ai controlli storici.
Il Ropidoxuridina, il principale sensibilizzatore alla radiazione di Shuttle Pharma, ha ricevuto la designazione di farmaco orfano dalla FDA. Si prevede che il trial si completi in 18-24 mesi in sei sedi diverse. Questo studio è importante per la comunità oncologica, con il potenziale di aumentare i tassi di cura e migliorare i risultati per i pazienti affetti da questo aggressivo tumore cerebrale.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ha anunciado su disposición para inscribir pacientes en un ensayo clínico de Fase 2 de Ropidoxuridina para tratar el glioblastoma. El ensayo, que se centra en pacientes con glioblastoma de tipo salvaje IDH y negativos a la metilación, inicialmente involucrará a 40 pacientes aleatorizados en dos grupos de dosificación. Se añadirán otros 14 pacientes una vez que se determine la dosis óptima. El estudio tiene como objetivo mejorar las tasas de supervivencia en comparación con los controles históricos.
Ropidoxuridina, el principal sensibilizador a la radiación de Shuttle Pharma, ha recibido la designación de medicamento huérfano de la FDA. Se espera que el ensayo se complete en 18 a 24 meses en seis ubicaciones. Este estudio es importante para la comunidad oncológica, potencialmente aumentando las tasas de cura y mejorando los resultados para los pacientes afectados por este agresivo tumor cerebral.
셔틀 제약 홀딩스 주식회사(Nasdaq: SHPH)는 로피독수리딘을 이용한 2상 임상 시험에 환자 등록을 시작할 준비가 되었음을 발표했습니다. 이 임상 시험은 IDH 야생형 및 메틸화 음성인 교모세포종 환자들을 대상으로 하며, 처음에 40명의 환자가 두 개의 복용량 그룹으로 무작위 배정될 것입니다. 최적의 용량이 결정되면 추가로 14명의 환자가 추가될 예정입니다. 연구의 목표는 역사적 대조군에 비하여 생존율을 향상시키는 것입니다.
로피독수리딘은 셔틀 제약의 주요 방사선 감작제로, FDA로부터 희귀 약물 지정을 받았습니다. 이 임상 시험은 6개 부지에서 18개월에서 24개월 사이에 완료될 예정입니다. 이 연구는 암 커뮤니티에 중요하며, 이 공격적인 뇌 종양에 대한 치료율을 높이고 환자 결과를 개선할 가능성이 있습니다.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) a annoncé sa préparation à recruter des patients pour un essai clinique de phase 2 sur le Ropidoxuridine pour traiter le glioblastome. L'essai, qui se concentre sur les patients atteints de glioblastome de type sauvage IDH et négatifs à la méthylation, impliquera initialement 40 patients randomisés en deux groupes de dosage. 14 patients supplémentaires seront ajoutés une fois la dose optimale déterminée. L'objectif de l'étude est d'améliorer les taux de survie par rapport aux témoins historiques.
Le Ropidoxuridine, le principal sensibilisateur aux radiations de Shuttle Pharma, a obtenu la dénomination de médicament orphelin de la FDA. L'étude devrait être complétée dans un délai de 18 à 24 mois sur six sites. Cette étude est importante pour la communauté oncologique, car elle pourrait augmenter les taux de guérison et améliorer les résultats pour les patients atteints de cette tumeur cérébrale agressive.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) hat die Bereitschaft angekündigt, Patienten für eine Phase-2-Studie zu Ropidoxuridin zur Behandlung von Glioblastomen zu rekrutieren. Die Studie, die sich auf IDH-Wildtyp- und methilierungsnegative Glioblastom-Patienten konzentriert, wird zunächst 40 Patienten umfassen, die in zwei Dosierungsgruppen randomisiert werden. Weitere 14 Patienten werden hinzugefügt, sobald die optimale Dosis bestimmt ist. Ziel der Studie ist es, die Überlebensraten im Vergleich zu historischen Kontrollen zu verbessern.
Ropidoxuridin, der wichtigste Strahlensensibilisierer von Shuttle Pharma, erhielt von der FDA die Orphan Drug Designation. Es wird erwartet, dass die Studie in 18 bis 24 Monaten an sechs Standorten abgeschlossen sein wird. Diese Studie ist wichtig für die Krebs-Community, da sie möglicherweise die Heilungsraten erhöht und die Patientenergebnisse für diesen aggressiven Gehirntumor verbessert.
- Phase 2 clinical trial for Ropidoxuridine in glioblastoma treatment is ready to enroll patients
- Ropidoxuridine has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity
- The trial targets a specific patient group (IDH wild-type, methylation negative glioblastoma) with treatment options
- The study design allows for determining optimal dosage and achieving statistical significance
- Potential to increase cancer cure rates, prolong patient survival, and improve quality of life for glioblastoma patients
- The Phase 2 clinical trial is expected to take 18 to 24 months to complete
- Results and efficacy of the treatment are yet to be determined
- The trial initially involves a relatively small sample size of 40 patients
Insights
The initiation of Shuttle Pharma's Phase 2 clinical trial for Ropidoxuridine in glioblastoma treatment is a significant milestone. This trial targets IDH wild-type, methylation negative glioblastoma, an aggressive form with treatment options. The dual-dose approach (
The potential impact is substantial, given the current poor prognosis for these patients (
However, investors should note the 18-24 month timeline for trial completion and consider the challenges in glioblastoma drug development historically.
Shuttle Pharma's focus on radiation sensitizers taps into a substantial market opportunity. With an estimated 400,000 patients in the US receiving curative radiation therapy annually and this number projected to grow by
The company's strategy to target glioblastoma, a rare but aggressive cancer, is shrewd. The Orphan Drug Designation not only provides potential market exclusivity but also often leads to faster regulatory review and financial incentives.
However, investors should consider the competitive landscape and the company's ability to successfully bring the drug to market. The trial's design, focusing on a specific glioblastoma subtype, may limit the initial market size but could lead to more targeted and effective treatment options.
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 locations, with all sites anticipated to be treating patients in the coming months.
“We have carefully selected six universities and hospitals that are most likely to treat IDH wild-type, methylation negative glioblastoma patients which should allow for more rapid enrollment of the Phase 2 trial,” added Dr. Tyvin Rich, Chief Medical Officer of Shuttle Pharma and Professor Emeritus of Radiation Oncology, University of Virginia School of Medicine.
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, filed with the SEC on March 20, 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
What is the purpose of Shuttle Pharma's Phase 2 clinical trial for Ropidoxuridine?
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What is the expected duration of Shuttle Pharma's Phase 2 clinical trial for Ropidoxuridine (SHPH)?
Has Ropidoxuridine received any special designations from the FDA for SHPH's glioblastoma treatment?
