Capricor Therapeutics to Present Long-Term Data from HOPE-2 Open Label Extension Study at 2024 World Muscle Society Congress
Capricor Therapeutics (NASDAQ: CAPR) announced it will present three-year safety and efficacy results from its HOPE-2 open-label extension (OLE) study for deramiocel, its lead asset for treating Duchenne muscular dystrophy (DMD). The data will be presented in a late-breaking poster at the 29th Annual Congress of the World Muscle Society (WMS 2024) in Prague, Czechia, from October 8-12, 2024.
The presentation, titled "Multi-modal benefits of deramiocel (CAP-1002) in late-stage patients with DMD: a new treatment approach to target skeletal and cardiac muscle pathogenesis (HOPE 2-OLE trial: 36-month data)," will be led by Dr. Craig McDonald from UC Davis. It will take place on October 11, 2024, from 9:45-10:45 a.m. EDT.
Linda Marbán, Ph.D., CEO of Capricor, stated that these results support the company's recent decision to begin filing a Biologics License Application (BLA) for potential approval of deramiocel to treat patients with DMD-cardiomyopathy.
Capricor Therapeutics (NASDAQ: CAPR) ha annunciato che presenterà i risultati di sicurezza ed efficacia dopo tre anni del suo studio di estensione in aperto HOPE-2 (OLE) per deramiocel, il suo principale asset per il trattamento della distrofia muscolare di Duchenne (DMD). I dati saranno presentati in un poster di rilievo al 29° Congresso Annuale della World Muscle Society (WMS 2024) a Praga, Repubblica Ceca, dal 8 al 12 ottobre 2024.
La presentazione, intitolata "Benefici multimodali di deramiocel (CAP-1002) in pazienti in fase avanzata con DMD: un nuovo approccio terapeutico per mirare alla patogenesi muscolare scheletrica e cardiaca (trial HOPE 2-OLE: dati di 36 mesi)," sarà condotta dal Dr. Craig McDonald dell'UC Davis. Si svolgerà l'11 ottobre 2024, dalle 9:45 alle 10:45 EDT.
Linda Marbán, Ph.D., CEO di Capricor, ha dichiarato che questi risultati supportano la recente decisione dell'azienda di iniziare a presentare una Domanda di Licenza Biologica (BLA) per la potenziale approvazione di deramiocel per trattare pazienti con cardiomiopatia DMD.
Capricor Therapeutics (NASDAQ: CAPR) anunció que presentará los resultados de seguridad y eficacia a tres años de su estudio de extensión abierto HOPE-2 (OLE) para deramiocel, su principal activo para tratar la distrofia muscular de Duchenne (DMD). Los datos se presentarán en un póster de última hora en el 29° Congreso Anual de la World Muscle Society (WMS 2024) en Praga, República Checa, del 8 al 12 de octubre de 2024.
La presentación, titulada "Beneficios multimodales de deramiocel (CAP-1002) en pacientes en etapa avanzada con DMD: un nuevo enfoque terapéutico para abordar la patogenia del músculo esquelético y cardíaco (ensayo HOPE 2-OLE: datos de 36 meses)," será dirigida por el Dr. Craig McDonald de UC Davis. Tendrá lugar el 11 de octubre de 2024, de 9:45 a 10:45 a.m. EDT.
Linda Marbán, Ph.D., directora ejecutiva de Capricor, declaró que estos resultados respaldan la reciente decisión de la compañía de comenzar a presentar una Solicitud de Licencia Biológica (BLA) para la posible aprobación de deramiocel para tratar a pacientes con cardiomiopatía DMD.
Capricor Therapeutics (NASDAQ: CAPR)는 deramiocel에 대한 HOPE-2 임상시험 (OLE)의 3년 안전성과 유효성 결과를 발표할 것이라고 발표했습니다. 이는 Duchenne 근육 디스트로피 (DMD) 치료를 위한 주요 자산입니다. 데이터는 2024년 10월 8일부터 12일까지 체코 프라하에서 열리는 세계 근육 학회(WMS 2024) 29차 연례 회의에서 발표될 예정입니다.
"DMD 말기 환자에서 deramiocel (CAP-1002)의 다중 모달 혜택: 골격 및 심장 근육 병리가에 대한 새로운 치료 접근법 (HOPE 2-OLE 시험: 36개월 데이터)"라는 제목의 발표는 UC Davis의 Craig McDonald 박사가 이끌 예정입니다. 이 발표는 2024년 10월 11일 오전 9:45부터 10:45까지 진행됩니다. EDT.
Capricor의 CEO인 Linda Marbán 박사는 이러한 결과가 DMD-심장병 환자를 치료하기 위해 deramiocel의 잠재적 승인을 위한 생물학적 제품 허가 신청 (BLA)을 제출하기로 한 회사의 최근 결정을 지지한다고 밝혔습니다.
Capricor Therapeutics (NASDAQ: CAPR) a annoncé qu'il présentera les résultats de sécurité et d'efficacité sur trois ans de son étude d'extension à étiquette ouverte HOPE-2 (OLE) pour deramiocel, son actif principal pour traiter la dystrophie musculaire de Duchenne (DMD). Les données seront présentées lors d'un poster à fort impact au 29ème Congrès Annuel de la World Muscle Society (WMS 2024) à Prague, République tchèque, du 8 au 12 octobre 2024.
La présentation, intitulée "Bénéfices multimodaux de deramiocel (CAP-1002) chez les patients en stade avancé avec DMD : une nouvelle approche thérapeutique visant la pathogénie musculaire squelettique et cardiaque (essai HOPE 2-OLE : données de 36 mois)," sera dirigée par le Dr. Craig McDonald de l'UC Davis. Elle aura lieu le 11 octobre 2024, de 9h45 à 10h45 EDT.
Linda Marbán, Ph.D., PDG de Capricor, a déclaré que ces résultats étayent la récente décision de l'entreprise de commencer à déposer une Demande de Licence Biologique (BLA) pour l'approbation potentielle de deramiocel pour traiter les patients présentant une cardiomyopathie DMD.
Capricor Therapeutics (NASDAQ: CAPR) gab bekannt, dass es die Sicherheits- und Wirksamkeitsdaten seiner HOPE-2 Offen-Untersuchung (OLE) für deramiocel, sein Hauptprodukt zur Behandlung der Duchenne-Muskeldystrophie (DMD), nach drei Jahren präsentieren wird. Die Daten werden während eines späten Posters auf dem 29. Jahrestagung der World Muscle Society (WMS 2024) in Prag, Tschechische Republik, vom 8. bis 12. Oktober 2024 präsentiert.
Die Präsentation mit dem Titel "Multimodale Vorteile von deramiocel (CAP-1002) bei Patienten in fortgeschrittenem Stadium mit DMD: Ein neuer Therapieansatz zur Zielsetzung der Skelett- und Herzmuskelerkrankung (HOPE 2-OLE Studie: 36-Monatsdaten)" wird von Dr. Craig McDonald von UC Davis geleitet. Sie findet am 11. Oktober 2024 von 9:45 bis 10:45 Uhr EDT statt.
Linda Marbán, Ph.D., CEO von Capricor, äußerte, dass diese Ergebnisse die kürzliche Entscheidung des Unternehmens unterstützen, einen Biologics License Application (BLA) für die potenzielle Genehmigung von deramiocel zur Behandlung von DMD-Kardiomyopathie-Patienten einzureichen.
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SAN DIEGO, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today that the Company will present the three-year safety and efficacy results from its HOPE-2 open-label extension (OLE) study with lead asset deramiocel for treating Duchenne muscular dystrophy (DMD). The data will highlight the long-term, multi-modal benefits of deramiocel in a late-breaking poster presentation at the 29th Annual Congress of the World Muscle Society (WMS 2024), taking place October 8-12, 2024, in Prague, Czechia.
“We look forward to sharing the latest updates from our HOPE-2 OLE trial at this year’s World Muscle Society Congress,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “The results of this study are foundational to our recent announcement to commence the filing of a Biologics License Application (BLA) for potential approval of deramiocel to treat patients with DMD-cardiomyopathy and continue to support the long-term impact of deramiocel for the treatment of DMD."
| Late Breaking Poster | |
| Title: | Multi-modal benefits of deramiocel (CAP-1002) in late-stage patients with DMD: a new treatment approach to target skeletal and cardiac muscle pathogenesis (HOPE 2-OLE trial: 36-month data) |
| Lead Author: | Dr. Craig McDonald (UC Davis) |
| Details: | 721LBP, Session 4, October 11, 2024 (9:45-10:45 a.m. EDT (15:45-16:45 CEST) |
A copy of the poster presentation will be added to the publications section of the Capricor website following the presentation. The full WMS 2024 program is available at https://www.wms2024.com/page/programme.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, deramiocel (CAP-1002), an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown deramiocel to demonstrate immunomodulatory, antifibrotic, and regenerative actions specifically tailored for dystrophinopathies and heart disease. Deramiocel is currently advancing through Phase 3 clinical development for the treatment of Duchenne muscular dystrophy. Capricor is also harnessing the power of its exosome technology, using its proprietary StealthX™ platform in preclinical development focused on the areas of vaccinology, targeted delivery of oligonucleotides, proteins and small molecule therapeutics to potentially treat and prevent a diverse array of diseases. At Capricor, we stand committed to pushing the boundaries of possibility and forging a path toward transformative treatments for those in need. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and Twitter.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; statements about our financial outlook; the ability to achieve product milestones and to receive milestone payments from commercial partners; plans regarding current and future collaborative activities and the ownership of commercial rights; potential future agreements; scope, duration, validity and enforceability of intellectual property rights; future revenue streams and projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission on March 11, 2024, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the Securities and Exchange Commission on August 8, 2024. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.
Capricor has entered into an agreement for the exclusive commercialization and distribution of deramiocel (CAP-1002) for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Deramiocel is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.
For more information, please contact:
Capricor Media Contact:
Raquel Cona
KCSA Strategic Communications
rcona@kcsa.com
212.896.1204
Capricor Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
858.727.1755
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