Shuttle Pharma Reaches Milestone in Patient Enrollment for Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
Shuttle Pharmaceuticals Holdings (SHPH) has reached 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma treatment. The trial design involves randomizing 40 patients into two dose levels: 1,200 mg/day and 960 mg/day, followed by enrolling 14 additional patients at the optimal dose.
The trial focuses on patients with IDH wild-type, methylation negative glioblastoma, where currently less than half survive beyond 12 months after diagnosis. The study is being conducted at six nationally recognized cancer centers. Ropidoxuridine, Shuttle Pharma's lead radiation sensitizer candidate, has received FDA Orphan Drug Designation.
The company aims to serve an estimated 400,000 US patients treated with radiation therapy for curative purposes annually, with this market expected to grow by 22% over the next five years.
Shuttle Pharmaceuticals Holdings (SHPH) ha raggiunto il 25% di arruolamento nella fase iniziale randomizzata del suo studio clinico di Fase 2 su Ropidoxuridina per il trattamento del glioblastoma. Il disegno dello studio prevede di randomizzare 40 pazienti in due livelli di dose: 1.200 mg/giorno e 960 mg/giorno, seguito dall'arruolamento di 14 pazienti aggiuntivi alla dose ottimale.
Lo studio si concentra su pazienti con glioblastoma di tipo IDH wild-type e metilazione negativa, dove attualmente meno della metà sopravvive oltre i 12 mesi dalla diagnosi. La ricerca viene condotta in sei centri oncologici nazionalmente riconosciuti. Ropidoxuridina, il principale candidato sensibilizzante alle radiazioni di Shuttle Pharma, ha ricevuto la designazione di farmaco orfano dalla FDA.
L'azienda mira a servire circa 400.000 pazienti statunitensi sottoposti annualmente a terapia radiativa a scopo curativo, con un mercato previsto in crescita del 22% nei prossimi cinque anni.
Shuttle Pharmaceuticals Holdings (SHPH) ha alcanzado el 25% de inscripciones en la parte inicial aleatorizada de su ensayo clínico de Fase 2 sobre Ropidoxuridina para el tratamiento del glioblastoma. El diseño del ensayo implica randomizar a 40 pacientes en dos niveles de dosis: 1,200 mg/día y 960 mg/día, seguidos de la inclusión de 14 pacientes adicionales a la dosis óptima.
El ensayo se centra en pacientes con glioblastoma de tipo IDH salvaje y metilación negativa, donde actualmente menos de la mitad sobrevive más de 12 meses después del diagnóstico. El estudio se está llevando a cabo en seis centros de cáncer reconocidos a nivel nacional. Ropidoxuridina, el principal candidato sensibilizante a la radiación de Shuttle Pharma, ha recibido la designación de medicamento huérfano por parte de la FDA.
La empresa tiene como objetivo atender aproximadamente a 400,000 pacientes en EE.UU. tratados anualmente con terapia de radiación con fines curativos, y se espera que este mercado crezca un 22% en los próximos cinco años.
Shuttle Pharmaceuticals Holdings (SHPH)는 교모세포종 치료를 위한 Ropidoxuridine의 2상 임상 시험 초기 무작위 부분에서 25%의 환자 등록을 완료했습니다. 시험 설계는 40명의 환자를 두 가지 용량 수준으로 무작위 배정하는 것을 포함합니다: 1,200 mg/일 및 960 mg/일, 이후 최적의 용량으로 14명의 추가 환자를 등록합니다.
이 시험은 IDH 야생형 및 메틸화 음성 교모세포종 환자에 중점을 두고 있으며, 현재 진단 후 12개월 이상 생존하는 환자는 절반도 채 되지 않습니다. 연구는 여섯 개의 국가적으로 인정받은 암 센터에서 진행되고 있습니다. Ropidoxuridine은 Shuttle Pharma의 주요 방사선 감작제 후보로, FDA의 희귀의약품 지정을 받았습니다.
회사는 매년 40만 명의 미국 환자에게 치유 목적으로 방사선 치료를 제공할 계획이며, 이 시장은 향후 5년 동안 22% 성장할 것으로 예상됩니다.
Shuttle Pharmaceuticals Holdings (SHPH) a atteint 25% d'inscription dans la partie initiale randomisée de son essai clinique de phase 2 concernant la Ropidoxuridine pour le traitement du glioblastome. La conception de l'essai implique de randomiser 40 patients dans deux niveaux de dose : 1 200 mg/jour et 960 mg/jour, suivie de l'inscription de 14 patients supplémentaires à la dose optimale.
L'essai se concentre sur les patients atteints de glioblastome de type IDH sauvage et de méthylation négative, où actuellement moins de la moitié survivent au-delà de 12 mois après le diagnostic. L'étude est menée dans six centres de cancer reconnus au niveau national. La Ropidoxuridine, le principal candidat sensibilisateur aux radiations de Shuttle Pharma, a reçu la désignation de médicament orphelin par la FDA.
L'entreprise vise à servir environ 400 000 patients américains traités chaque année par radiothérapie à des fins curatives, ce marché étant prévu pour croître de 22 % au cours des cinq prochaines années.
Shuttle Pharmaceuticals Holdings (SHPH) hat eine Einschreibung von 25% im initialen randomisierten Teil seiner Phase-2-Studie zu Ropidoxuridin zur Behandlung von Glioblastomen erreicht. Das Studiendesign sieht vor, 40 Patienten in zwei Dosisstufen zu randomisieren: 1.200 mg/Tag und 960 mg/Tag, gefolgt von der Rekrutierung von 14 zusätzlichen Patienten bei der optimalen Dosis.
Die Studie konzentriert sich auf Patienten mit IDH Wildtyp, methylierungsnegativem Glioblastom, bei denen derzeit weniger als die Hälfte länger als 12 Monate nach der Diagnose überlebt. Die Studie wird an sechs landesweit anerkannten Krebszentren durchgeführt. Ropidoxuridin, Shuttle Phamas führender Strahlensensibilisierer, hat die FDA-Designierung als Orphan Drug erhalten.
Das Unternehmen beabsichtigt, jährlich etwa 400.000 US-Patienten zu bedienen, die mit Strahlentherapie zu Heilzwecken behandelt werden, wobei dieser Markt in den nächsten fünf Jahren voraussichtlich um 22% wachsen wird.
- Achieved 25% enrollment in Phase 2 Clinical Trial ahead of expectations
- FDA Orphan Drug Designation secured, providing potential marketing exclusivity
- Trial conducted across six major national cancer centers
- Large addressable market of 400,000 patients with 22% growth expected in 5 years
- None.
Insights
The 25% enrollment milestone in Shuttle Pharma's Phase 2 trial for Ropidoxuridine represents critical progress in addressing an urgent unmet medical need. The trial's design targeting IDH wild-type, methylation negative glioblastoma patients - who currently face treatment options and poor survival rates - is particularly noteworthy.
The dose-finding approach (1,200 mg/day vs. 960 mg/day) followed by an expansion cohort is strategically sound for establishing optimal dosing. With six major cancer centers participating and enrollment ahead of schedule, this accelerates the pathway to potential FDA approval. The Orphan Drug Designation provides important market protection and development incentives.
The addressable market of
This trial targets a devastating form of brain cancer where less than
The multi-center approach involving prestigious institutions strengthens the trial's credibility. The focus on IDH wild-type, methylation negative glioblastoma is particularly strategic - this aggressive subtype has the worst prognosis and fewest treatment options. A successful outcome could establish a new standard of care.
In simpler terms: imagine radiation therapy as a key that only partially unlocks cancer cell destruction. Ropidoxuridine could act like a "master key," potentially making radiation more effective at destroying cancer cells while sparing healthy tissue. This could mean longer survival and better quality of life for patients with one of the most aggressive brain cancers.
GAITHERSBURG, Md., Jan. 21, 2025 (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 it has achieved
The Phase 2 trial design is to initially randomize 40 patients into two different dose levels, with 20 patients receiving 1,200 mg/day and 20 patients receiving 960 mg/day, to determine an optimal dose for use in glioblastoma patients. Once the optimal dose is identified, 14 additional patients will be enrolled at the optimal dose to reach statistical significance with the end-point demonstrating survival as compared to historical controls. The Phase 2 clinical trial is being conducted on patients presenting with the most aggressive form of brain tumors– IDH wild-type, methylation negative glioblastoma. This cohort of patients currently only have radiation as the standard of care, with less than half of the patients surviving beyond 12 months after diagnosis.
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 previously received Orphan Drug Designation from the FDA, providing Shuttle Pharma with potential marketing exclusivity upon obtaining FDA approval for treatment of this disease.
The Phase 2 trial is conducted at Georgetown University Medical Center, Allegheny Health Network (AHN) Cancer Institute, UNC Medical Center, the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, and Miami Cancer Institute, part of Baptist Health South Florida.
“Enrollment into the trial is ahead of our expectations,” commented Shuttle Pharma's CEO and Chairman, Anatoly Dritschilo, M.D. “I am grateful to the teams at each of these nationally recognized cancer centers for their participation in the trial as we look to develop 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. The reader is cautioned not to rely on such forward-looking statements. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including our expectations regarding the success and/or completion of our Phase 2 clinical trials; our success in completing any newly initiated clinical trials, commence new trials and obtain regulatory approval following such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statements. Forward-looking statements are only predictions and 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
What is the current enrollment status of SHPH's Phase 2 Clinical Trial for Ropidoxuridine?
How many patients will be enrolled in SHPH's Phase 2 Clinical Trial for glioblastoma?
What dosage levels are being tested in SHPH's Ropidoxuridine Phase 2 trial?
What is the market potential for SHPH's radiation sensitizers?
Which medical centers are participating in SHPH's Phase 2 glioblastoma trial?
