Shuttle Pharma Provides Second Quarter 2024 Corporate Update
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has provided a corporate update for Q2 2024. Key highlights include:
1. Enrollment has begun in the Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment.
2. Two out of six planned site locations are ready to treat patients.
3. Shuttle Pharma received FDA Orphan Drug Designation for Ropidoxuridine.
4. The trial will involve 40 patients initially, with an additional 14 patients once the optimal dose is determined.
5. The company has regained compliance with Nasdaq's Listing Rule 5250(c) after filing delayed financial reports.
Shuttle Pharma aims to improve outcomes for cancer patients treated with radiation therapy by developing radiation sensitizers.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ha fornito un aggiornamento aziendale per il secondo trimestre del 2024. I punti salienti includono:
1. È iniziato il reclutamento nel trial clinico di Fase 2 per il trattamento del glioblastoma con Ropidoxuridina.
2. Due delle sei sedi previste sono pronte per trattare i pazienti.
3. Shuttle Pharma ha ricevuto la Designazione di Farmaco Orfano dalla FDA per Ropidoxuridina.
4. Il trial coinvolgerà inizialmente 40 pazienti, con ulteriori 14 pazienti una volta stabilita la dose ottimale.
5. L'azienda ha ripristinato la conformità con la Regola di Quotazione 5250(c) di Nasdaq dopo aver presentato i rapporti finanziari in ritardo.
Shuttle Pharma mira a migliorare gli esiti per i pazienti oncologici trattati con radioterapia sviluppando sensibilizzatori alla radioterapia.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ha proporcionado una actualización corporativa para el segundo trimestre de 2024. Los aspectos destacados incluyen:
1. Se ha comenzado a reclutar en el ensayo clínico de Fase 2 de Ropidoxuridina para el tratamiento del glioblastoma.
2. Dos de los seis sitios planificados están listos para tratar pacientes.
3. Shuttle Pharma recibió la Designación de Medicamento Huérfano de la FDA para Ropidoxuridina.
4. El ensayo involucrará inicialmente a 40 pacientes, con otros 14 pacientes una vez que se determine la dosis óptima.
5. La empresa ha recuperado la conformidad con la Regla de Listado 5250(c) de Nasdaq después de presentar informes financieros con retraso.
Shuttle Pharma tiene como objetivo mejorar los resultados para los pacientes con cáncer tratados con radioterapia mediante el desarrollo de sensibilizadores a la radioterapia.
셔틀 제약 홀딩스 주식회사 (Nasdaq: SHPH)는 2024년 2분기 기업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. 교모세포종 치료를 위한 로피독수리딘의 2상 임상 시험에서 환자 등록이 시작되었습니다.
2. 치료를 위한 6개 예정 장소 중 2곳이 준비되었습니다.
3. 셔틀 제약은 로피독수리딘에 대해 FDA의 희귀 약물 지정을 받았습니다.
4. 이 시험은 초기에는 40명의 환자를 포함하고, 최적의 용량이 결정되면 추가로 14명의 환자가 포함될 것입니다.
5. 이 회사는 지연된 재무 보고서를 제출한 후 나스닥 5250(c) 상장 규정을 준수하게 되었습니다.
셔틀 제약은 방사선 치료를 받는 암 환자의 치료 결과를 개선하기 위해 방사선 감작제를 개발하고자 합니다.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) a fourni une mise à jour de l'entreprise pour le deuxième trimestre 2024. Les points clés incluent :
1. L'inscription a commencé dans l'essai clinique de Phase 2 de la Ropidoxuridine pour le traitement du glioblastome.
2. Deux des six sites prévus sont prêts à traiter des patients.
3. Shuttle Pharma a reçu la désignation de médicament orphelin par la FDA pour la Ropidoxuridine.
4. L'essai impliquera initialement 40 patients, avec 14 patients supplémentaires une fois la dose optimale déterminée.
5. L'entreprise a retrouvé sa conformité avec la règle de cotation 5250(c) de Nasdaq après avoir déposé des rapports financiers en retard.
Shuttle Pharma vise à améliorer les résultats pour les patients atteints de cancer traités par radiothérapie en développant des sensibilisateurs à la radiothérapie.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) hat ein Unternehmensupdate für das 2. Quartal 2024 bereitgestellt. Wichtige Highlights sind:
1. Die Rekrutierung hat im Phase-2-Studienversuch mit Ropidoxuridin zur Behandlung von Glioblastomen begonnen.
2. Zwei von sechs geplanten Standorten sind bereit, Patienten zu behandeln.
3. Shuttle Pharma erhielt die FDA-Waise Medikamentenbezeichnung für Ropidoxuridin.
4. Die Studie wird zunächst 40 Patienten umfassen, mit zusätzlichen 14 Patienten, sobald die optimale Dosis bestimmt ist.
5. Das Unternehmen hat die Einhaltung der Nasdaq-Listing-Regel 5250(c) nach der Einreichung verspäteter Finanzberichte wiedererlangt.
Shuttle Pharma zielt darauf ab, die Ergebnisse für Krebspatienten, die mit Strahlentherapie behandelt werden, durch die Entwicklung von Strahlenempfindlichmachern zu verbessern.
- Enrollment has begun in Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment
- FDA granted Orphan Drug Designation for Ropidoxuridine, providing potential marketing exclusivity
- Company regained compliance with Nasdaq's Listing Rule 5250(c)
- Delay in filing Q2 2023 Quarterly Report due to re-audit requirement
- Temporary non-compliance with Nasdaq's Listing Rule 5250(c)
The commencement of Shuttle Pharma's Phase 2 clinical trial for Ropidoxuridine in glioblastoma treatment is a significant milestone. With two out of six planned sites now ready to enroll patients, this marks a important step in evaluating the drug's efficacy as a radiation sensitizer. The trial's focus on IDH wild-type, methylation negative glioblastoma - an aggressive form with treatment options - could potentially address a critical unmet need.
The two-dose randomization strategy (1,200 mg/day vs. 960 mg/day) is a smart approach to determine optimal dosing. The 18-24 month expected trial duration is reasonable for assessing survival outcomes. However, investors should note that glioblastoma trials often face challenges due to the aggressive nature of the disease and potential for rapid progression.
Shuttle Pharma's recent filings and regained Nasdaq compliance are positive developments, addressing previous concerns about financial reporting. The company's ability to resolve the audit issues and meet Nasdaq requirements demonstrates management's commitment to transparency and regulatory compliance.
However, investors should be aware that clinical-stage biotech companies like Shuttle Pharma often face financial challenges. The company's focus on a single lead candidate, Ropidoxuridine, presents both opportunity and risk. While positive trial results could significantly boost the company's value, any setbacks could have a substantial negative impact. The Orphan Drug Designation for Ropidoxuridine is a notable advantage, potentially providing market exclusivity upon FDA approval.
GAITHERSBURG, Md., Sept. 04, 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), 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.
“Reaching this important milestone of putting drug into patients doesn’t happen overnight,” stated Dr. Dritschilo. “There are a number of critical steps we have executed on during these past two years to reach this point, including the manufacturing of the active pharmaceutical ingredient (API) of Ropidoxuridine by our contractor TCG GreenChem and formulation into the drug product by the University of Iowa Pharmaceuticals I simply couldn’t be more pleased with how diligently our team has worked to execute the required steps necessary to initiate this clinical trial. We are now one step closer to achieving our mission of improving the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of radiation therapy while limiting the late effects of radiation in cancer treatment.”
Nasdaq Update:
Due to the recent SEC sanctions against B.F. Borgers, CPA, PC, an auditor previously engaged by Shuttle Pharma, a re-audit of prior years’ financial statements has been required and was performed by Shuttle Pharma’s current auditors, Forvis Mazars, LLP. This re-audit caused a delay in filing our Quarterly Report on Form 10-Q for the period ended June 30, 2023 (the “Q2 Quarterly Report”). As a result, on August 21, 2024, Shuttle Pharma received notice from the Nasdaq Stock Exchange, LLC that it had fallen out of compliance with Nasdaq’s Listing Rule 5250(c) for not timely filing the Q2 Quarterly Report. As of today’s date, Shuttle Pharma has now filed its Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023, including the re-audited information, as well as its Quarterly Report on Form 10-Q/A for the period ended March 31, 2024 and the Q2 Quarterly Report. Following these filings, Shuttle Pharma has now regained compliance with Listing Rule 5250(c).
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
What is the current status of Shuttle Pharma's (SHPH) Phase 2 clinical trial for Ropidoxuridine?
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What is the significance of the FDA Orphan Drug Designation for Shuttle Pharma's (SHPH) Ropidoxuridine?
Has Shuttle Pharma (SHPH) resolved its compliance issues with Nasdaq as of September 2024?
