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CEL-SCI to Present New Data for Multikine® Head & Neck Cancer Immunotherapy at the European Society for Medical Oncology 2024 Congress

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CEL-SCI (NYSE American: CVM) announced it will present new data from its Phase 3 study of Multikine at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain. The poster, titled 'Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy,' will be presented on September 14, 2024.

CEL-SCI has received FDA approval to start a confirmatory Registration Study of Multikine for head and neck cancer treatment, based on strong safety and efficacy data from its completed IT-MATTERS Phase 3 study. The study's co-author, Dr. József Tímár, a respected pathologist and Professor at Semmelweis University, will present the findings. CEL-SCI plans to release a press release with the new data before market open on September 16, 2024.

CEL-SCI (NYSE American: CVM) ha annunciato che presenterà nuovi dati dal suo studio di Fase 3 su Multikine al Congresso della Società Europea di Oncologia Medica (ESMO) 2024 di Barcellona, Spagna. Il poster, intitolato 'Significato prognostico della stadiazione diagnostica nei pazienti naïve al trattamento, con carcinoma a cellule squamose avanzato localmente resecabile della cavità orale per immunoterapia con iniezione di interleuchina leucocitaria neoadiuvante,' sarà presentato il 14 settembre 2024.

CEL-SCI ha ricevuto l'approvazione dalla FDA per avviare uno studio di registrazione confermativo di Multikine per il trattamento del cancro testa-collo, basato su forti dati di sicurezza ed efficacia provenienti dallo studio IT-MATTERS di Fase 3 completato. L'autore coadiuvante dello studio, Dr. József Tímár, un rispettato patologo e professore all'Università Semmelweis, presenterà i risultati. CEL-SCI prevede di rilasciare un comunicato stampa con i nuovi dati prima dell'apertura del mercato il 16 settembre 2024.

CEL-SCI (NYSE American: CVM) anunció que presentará nuevos datos de su estudio de Fase 3 sobre Multikine en el Congreso de la Sociedad Europea de Oncología Médica (ESMO) 2024 en Barcelona, España. El póster, titulado 'Significado pronóstico de la estadificación diagnóstica en cáncer de cavidad oral, localmente avanzado y resecable en pacientes naïve al tratamiento, para la inmunoterapia con inyección de interleucina leucocitaria neoadyuvante,' se presentará el 14 de septiembre de 2024.

CEL-SCI ha recibido la aprobación de la FDA para iniciar un estudio de registro confirmatorio de Multikine para el tratamiento de cáncer de cabeza y cuello, basado en sólidos datos de seguridad y eficacia del estudio IT-MATTERS de Fase 3 completado. El coautor del estudio, Dr. József Tímár, un respetado patólogo y profesor en la Universidad Semmelweis, presentará los hallazgos. CEL-SCI planea emitir un comunicado de prensa con los nuevos datos antes de la apertura del mercado el 16 de septiembre de 2024.

CEL-SCI (NYSE American: CVM)는 스페인 바르셀로나에서 열리는 2024년 유럽 종양학회(ESMO) Congress에서 Multikine의 3상 연구 결과를 발표할 것이라고 발표했습니다. '치료 경험이 없는, 수술 가능한 국소 진행성 구강 암에서의 진단 단계의 예후적 의미: 신보조 림프구 인터루킨 주입 면역 요법'이라는 제목의 포스터는 2024년 9월 14일에 발표될 예정입니다.

CEL-SCI는 완료된 IT-MATTERS 3상 연구의 강력한 안전성과 효능 데이터에 기반하여 두경부암 치료를 위한 Multikine의 확인적 등록 연구를 시작하는 FDA 승인을 받았습니다. 연구의 공동 저자인 Dr. József Tímár는 세멜바이스 대학교의 존경받는 병리학자로, 연구 결과를 발표할 것입니다. CEL-SCI는 2024년 9월 16일 시장 개장 전에 새로운 데이터를 담은 보도 자료를 발표할 계획입니다.

CEL-SCI (NYSE American: CVM) a annoncé qu'elle présentera de nouvelles données provenant de son étude de Phase 3 sur Multikine lors du Congrès de la Société Européenne d'Oncologie Médicale (ESMO) 2024 à Barcelone, Espagne. L'affiche, intitulée 'Signification pronostique de la stadification diagnostique chez des patients naïfs de traitement, avec un carcinome épidermoïde primitif avancé localement resectable de la cavité orale pour l'immunothérapie par injection de leucocytes interleukine néoadjuvante,' sera présentée le 14 septembre 2024.

CEL-SCI a reçu l'approbation de la FDA pour commencer une étude d'enregistrement confirmatoire de Multikine pour le traitement du cancer de la tête et du cou, sur la base de solides données de sécurité et d'efficacité tirées de son étude IT-MATTERS en phase 3 achevée. Le coauteur de l'étude, Dr. József Tímár, un pathologiste respecté et professeur à l'Université Semmelweis, présentera les résultats. CEL-SCI prévoit de publier un communiqué de presse avec les nouvelles données avant l'ouverture des marchés le 16 septembre 2024.

CEL-SCI (NYSE American: CVM) gab bekannt, dass es neue Daten aus seiner Phase-3-Studie zu Multikine auf dem Europäischen Kongress für Medizinische Onkologie (ESMO) 2024 in Barcelona, Spanien, präsentieren wird. Das Poster mit dem Titel 'Prognostische Bedeutung der diagnostischen Stadienbestimmung bei behandlungsnaiven, resektablen, lokal fortgeschrittenen Plattenepithelkarzinomen der Mundhöhle für die neoadjuvante Injektion von Interleukin in therapeutischer Immuntherapie' wird am 14. September 2024 vorgestellt.

CEL-SCI hat die Genehmigung der FDA erhalten, eine bestätigende Registrierungstudie zu Multikine für die Behandlung von Kopf-Hals-Krebs zu starten, basierend auf soliden Sicherheits- und Wirksamkeitsdaten aus der abgeschlossenen IT-MATTERS Phase-3-Studie. Der Co-Autor der Studie, Dr. József Tímár, ein angesehener Pathologe und Professor an der Semmelweis-Universität, wird die Ergebnisse präsentieren. CEL-SCI plant, vor der Markteröffnung am 16. September 2024 eine Pressemitteilung mit den neuen Daten herauszugeben.

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Data to be presented on Saturday, September 14 and published via a press release before the open of market on Monday, September 16

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today reported it will report new data from its Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* at the European Society for Medical Oncology (ESMO) 2024 Congress which takes place from September 13 – 17, 2024 in Barcelona, Spain. A poster titled “Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy” will be presented by the study’s co-author József Tímár MD, PhD, DSc, a prominent and highly respected pathologist.

CEL-SCI has received the go-ahead from the U.S. Food and Drug Administration (FDA) to commence a confirmatory Registration Study of Multikine in the treatment of head and neck cancer based on strong safety and efficacy data from its IT-MATTERS completed Phase 3 study.

Dr. Timar is Professor Department of Pathology, Forensic and Insurance Medicine at Semmelweis University in Budapest, Hungary, and served as the Director of the Central Pathology Laboratory for the IT-MATTERS study. With 174 peer reviewed studies published, Dr. Timar is a founding editor, editor in chief, or a member of the editorial board of four oncology journals. He is the recipient of a dozen honors and awards for excellence in cancer research and teaching.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without Multikine at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced primary head and neck cancer patients who present with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients (globally) annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

When will CEL-SCI (CVM) present new Multikine data at ESMO 2024?

CEL-SCI (CVM) will present new Multikine data on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain.

What is the focus of CEL-SCI's (CVM) poster presentation at ESMO 2024?

The poster presentation focuses on the prognostic significance of diagnostic staging in treatment-naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy (Multikine).

Has CEL-SCI (CVM) received FDA approval for a new Multikine study?

Yes, CEL-SCI (CVM) has received FDA approval to commence a confirmatory Registration Study of Multikine for the treatment of head and neck cancer, based on data from its completed IT-MATTERS Phase 3 study.

Who will present CEL-SCI's (CVM) Multikine data at ESMO 2024?

Dr. József Tímár, a respected pathologist and Professor at Semmelweis University, will present CEL-SCI's (CVM) Multikine data at ESMO 2024.

When will CEL-SCI (CVM) release a press release about the new Multikine data?

CEL-SCI (CVM) plans to release a press release with the new Multikine data before the market opens on Monday, September 16, 2024.

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