CEL-SCI Selects Ergomed as CRO as it Gears Up for Confirmatory FDA Registration Study of Multikine® in Head and Neck Cancer
CEL-SCI (NYSE American: CVM) has announced a renewed collaboration with Ergomed Clinical Research for its upcoming FDA confirmatory Registration Study of Multikine® in head and neck cancer. The study, set to enroll 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on those with no lymph node involvement and low PD-L1 tumor expression. Ergomed will provide global comprehensive clinical operations support to ensure efficient trial execution.
This partnership builds on their previous successful collaboration in the largest Phase 3 trial ever conducted in head and neck cancer. CEL-SCI has also received pediatric waivers from the UK's MHRA and the EMA. The study is planned to commence in Q1 2025 across multiple countries. In prior studies, Multikine showed promising results, with a 5-year survival rate of 73% vs 45% in the control group for the target population.
CEL-SCI (NYSE American: CVM) ha annunciato una collaborazione rinnovata con Ergomed Clinical Research per il suo prossimo Studio di Registrazione Confermativo FDA di Multikine® nel carcinoma testa-collo. Lo studio, che prevede di arruolare 212 pazienti recentemente diagnosticati con carcinoma testa-collo primario localmente avanzato, si concentrerà su quelli senza coinvolgimento degli linfonodi e con bassa espressione tumorale di PD-L1. Ergomed fornirà un supporto globale completo per le operazioni cliniche per garantire un'esecuzione del trial efficiente.
Questa partnership si basa sulla precedente collaborazione di successo nel più grande studio di Fase 3 mai condotto nel carcinoma testa-collo. CEL-SCI ha anche ricevuto esenzioni pediatriche dall'MHRA del Regno Unito e dall'EMA. Lo studio è previsto per iniziare nel Q1 2025 in diversi paesi. Negli studi precedenti, Multikine ha mostrato risultati promettenti, con un tasso di sopravvivenza del 73% a 5 anni contro il 45% nel gruppo di controllo per la popolazione target.
CEL-SCI (NYSE American: CVM) ha anunciado una colaboración renovada con Ergomed Clinical Research para su próximo Estudio de Registro Confirmatorio de la FDA de Multikine® en cáncer de cabeza y cuello. El estudio, que reclutará a 212 pacientes recién diagnosticados con cáncer de cabeza y cuello primario localmente avanzado, se centrará en aquellos sin afectación de ganglios linfáticos y con baja expresión tumoral de PD-L1. Ergomed proporcionará soporte global integral para las operaciones clínicas para garantizar una ejecución eficiente del ensayo.
Esta asociación se basa en su anterior colaboración exitosa en el mayor ensayo de Fase 3 jamás realizado en cáncer de cabeza y cuello. CEL-SCI también ha recibido exenciones pediátricas de la MHRA del Reino Unido y de la EMA. Se planea que el estudio comience en el Q1 de 2025 en varios países. En estudios anteriores, Multikine mostró resultados prometedores, con una tasa de supervivencia del 73% a 5 años frente al 45% en el grupo de control para la población objetivo.
CEL-SCI (NYSE American: CVM)은 Ergomed Clinical Research와의 renewed 협력을 발표했으며, 이는 FDA 확인 등록 연구 Multikine®의 두경부 암 관련 연구입니다. 이 연구는 국소 진행성 두경부 암으로 새로 진단받은 212명의 환자를 등록할 예정이며, 림프절 침범이 없고 PD-L1 종양 발현이 낮은 환자에 초점을 맞출 것입니다. Ergomed는 효율적인 시험 실행을 보장하기 위한 전 세계적인 포괄적 임상 운영 지원을 제공할 것입니다.
이 파트너십은 두경부 암에서 진행된 최대 규모의 3상 시험에서의 성공적인 협력을 기반으로 합니다. CEL-SCI는 또한 영국 MHRA와 EMA로부터 소아 면제를 받았습니다. 이 연구는 2025년 1분기에 여러 국가에서 시작될 예정입니다. 이전 연구에서 Multikine는 목표 집단에서 5년 생존률이 73%로 대조군의 45%에 비해 유망한 결과를 보였습니다.
CEL-SCI (NYSE American: CVM) a annoncé une collaboration renouvelée avec Ergomed Clinical Research pour son prochain Étude d'Enregistrement Confirmatoire de la FDA de Multikine® dans le cancer de la tête et du cou. L'étude, qui prévoit d'inclure 212 patients récemment diagnostiqués avec un cancer de la tête et du cou primitif localement avancé, se concentrera sur ceux sans atteinte des ganglions lymphatiques et avec une faible expression tumorale de PD-L1. Ergomed fournira un soutien opérationnel clinique complet à l'échelle mondiale pour garantir une exécution efficace de l'essai.
Ce partenariat s'appuie sur leur précédente collaboration réussie dans le plus grand essai de Phase 3 jamais réalisé dans le cancer de la tête et du cou. CEL-SCI a également reçu des exemptions pédiatriques de la MHRA du Royaume-Uni et de l'EMA. L'étude devrait commencer au premier trimestre 2025 dans plusieurs pays. Dans les études précédentes, Multikine a montré des résultats prometteurs, avec un taux de survie à 5 ans de 73 % contre 45 % dans le groupe témoin pour la population cible.
CEL-SCI (NYSE American: CVM) hat eine erneute Zusammenarbeit mit Ergomed Clinical Research für die anstehende FDA-Bestätigungsregistrierungsstudie von Multikine® bei Kopf- und Halskrebs angekündigt. Die Studie wird 212 neu diagnostizierte Patienten mit lokal fortgeschrittenem primären Kopf- und Halskrebs einschließen, die ohne Lymphknotenbeteiligung und mit niedriger PD-L1-Tumorexpression sind. Ergomed wird umfassende globale klinische Betriebsunterstützung bieten, um eine effiziente Durchführung der Studie zu gewährleisten.
Diese Partnerschaft baut auf ihrer vorherigen erfolgreichen Zusammenarbeit in der bisher größten Phase-3-Studie zu Kopf- und Halskrebs auf. CEL-SCI hat auch kinderärztliche Befreiungen von der MHRA des Vereinigten Königreichs und der EMA erhalten. Die Studie soll im ersten Quartal 2025 in mehreren Ländern beginnen. In früheren Studien zeigte Multikine vielversprechende Ergebnisse mit einer 5-Jahres-Überlebensrate von 73% im Vergleich zu 45% in der Kontrollgruppe für die Zielpopulation.
- Renewed collaboration with Ergomed, a trusted partner with a strong track record in fast enrollment and high-quality study delivery
- Received pediatric waivers from UK's MHRA and EMA, marking important regulatory milestones
- Previous Multikine studies showed significant improvement in survival rates (73% vs 45% in control group) for the target population
- Confirmatory study represents a important step toward potential marketing approval of Multikine
- Study commencement planned for Q1 2025, indicating a significant wait time before potential results and market entry
Insights
This collaboration between CEL-SCI and Ergomed for the confirmatory FDA registration study of Multikine is a significant step towards potential approval. The study, targeting 212 patients with locally advanced primary head and neck cancer, focuses on a specific subgroup with no lymph node involvement and low PD-L1 expression. This targeted approach, based on previous promising results, could enhance the study's chances of success.
The prior Phase 3 trial showed impressive results in the target population, with a
However, investors should note that the study is not set to commence until Q1 2025, indicating a long timeline before potential commercialization. The global nature of the trial and Ergomed's track record in fast enrollment could help mitigate delays, but regulatory approval processes will still take considerable time post-study completion.
For CEL-SCI, a small-cap company with a market capitalization of about
The recent regulatory milestones, including positive FDA feedback and pediatric waivers from MHRA and EMA, indicate progress in clearing regulatory hurdles. These developments, coupled with the targeted study design, may increase investor confidence in the potential for eventual approval.
However, the extended timeline to study commencement in Q1 2025 presents both a challenge and an opportunity. While it allows time for thorough preparation, it also means a significant period before potential revenue generation. Investors should consider the company's cash runway and potential need for additional financing to support operations until study completion and potential product launch.
As a clinical research organization (CRO) Ergomed has a strong track record with CEL-SCI in fast enrolment and high quality study delivery
Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market.
This partnership marks a continuation of the successful cooperation between the two companies, building on their previous collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer.
In addition to the positive outcome from its recent meeting with the FDA regarding the path to approval for its first-line investigational cancer immunotherapy, CEL-SCI achieved other major milestones including receiving pediatric waivers from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
This confirmatory study represents a crucial step toward potential marketing approval of Multikine. The study, set to enrol 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on patients with no lymph node involvement and low PD-L1 tumour expression. Patients will be enrolled across multiple sites globally, underscoring the strength of Ergomed’s global clinical trial management capabilities.
Geert Kersten, CEO of CEL-CI commented, “Ergomed is a trusted partner. Our past experience taught us that they are highly competent and motivated. Their enrolment was fast and the study was clean. The plan is for the study to commence in Q1 2025 in multiple countries.”
Dr. Sy Pretorius, CEO of Ergomed Group, added, "We are excited to once again partner with CEL-SCI on this significant trial for Multikine. Our prior collaboration has set a strong foundation for this new phase, and we are committed to leveraging our global expertise in oncology clinical research to support this critical confirmatory study. Together, we aim to advance innovative therapies that can make a real impact on patients' lives."
Multikine has already demonstrated promising results in its prior studies, showing a significant improvement in survival rates. In the target population for the confirmatory study, patients treated with Multikine had a 5-year survival of
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
The Company has operations in
About Ergomed
Founded in 1997, Ergomed supports pharmaceutical companies with services spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Recognized internationally in both rare disease and oncology drug development for its expertise, Ergomed offers a full range of quality clinical research and clinical trial management services along with an industry-leading suite of specialized pharmacovigilance solutions. By providing this full-service offering, Ergomed enables emerging and established life sciences companies to meet their regulatory obligations, maximize their drug development success and their product value. For more information: info@ergomedgroup.com.
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.
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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
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