CEL-SCI Reports New Data: Treatment with Multikine Resulted in up to 95% Improvement in Quality of Life for Head and Neck Cancer Patients
CEL-SCI (NYSE: CVM) has published new data from its Phase 3 study of Multikine in the Pathology and Oncology Research journal, showing significant quality of life improvements for head and neck cancer patients.
Key findings from the study revealed that 95.1% of complete responders to Multikine reported improved quality of life, with 100% improvement in 60% of measures. Additionally, 89.4% of partial responders reported enhanced quality of life metrics.
The quality of life improvements included:
- Reduction or elimination of head and neck pain
- Enhanced ability to eat, drink, and swallow
- Improved self-care capabilities
- Better emotional wellbeing
The study, which was the largest ever conducted for newly diagnosed locally advanced head and neck cancer, demonstrated 45 objective early responders in the Multikine treated group compared to zero in the control group. Multikine is now proceeding to a final confirmatory Registration Study.
CEL-SCI (NYSE: CVM) ha pubblicato nuovi dati dal suo studio di Fase 3 su Multikine nella rivista Pathology and Oncology Research, mostrando significativi miglioramenti nella qualità della vita per i pazienti affetti da cancro testa-collo.
I risultati chiave dello studio hanno rivelato che il 95,1% dei rispondenti completi a Multikine ha riportato un miglioramento della qualità della vita, con un miglioramento del 100% in 60% delle misure. Inoltre, l'89,4% dei rispondenti parziali ha segnalato metriche di qualità della vita migliorate.
I miglioramenti nella qualità della vita includevano:
- Riduzione o eliminazione del dolore alla testa e al collo
- Migliorata capacità di mangiare, bere e deglutire
- Capacità di auto-cura migliorate
- Maggiore benessere emotivo
Lo studio, il più grande mai condotto per pazienti recentemente diagnosticati con cancro testa-collo localmente avanzato, ha dimostrato 45 rispondenti obiettivi precoci nel gruppo trattato con Multikine rispetto a zero nel gruppo di controllo. Multikine sta ora procedendo verso uno studio di registrazione finale confermativo.
CEL-SCI (NYSE: CVM) ha publicado nuevos datos de su estudio de Fase 3 sobre Multikine en la revista Pathology and Oncology Research, mostrando mejoras significativas en la calidad de vida de los pacientes con cáncer de cabeza y cuello.
Los hallazgos clave del estudio revelaron que el 95.1% de los respondedores completos a Multikine informaron mejoras en la calidad de vida, con un 100% de mejora en el 60% de las medidas. Además, el 89.4% de los respondedores parciales reportaron métricas de calidad de vida mejoradas.
Las mejoras en la calidad de vida incluyeron:
- Reducción o eliminación del dolor de cabeza y cuello
- Mejor capacidad para comer, beber y tragar
- Mejoras en las capacidades de autocuidado
- Mejor bienestar emocional
El estudio, que fue el más grande jamás realizado para pacientes recién diagnosticados con cáncer de cabeza y cuello localmente avanzado, demostró 45 respondedores tempranos objetivos en el grupo tratado con Multikine en comparación con cero en el grupo de control. Multikine ahora avanza hacia un estudio de registro final confirmatorio.
CEL-SCI (NYSE: CVM)는 Pathology and Oncology Research 저널에 Multikine의 3상 연구에서 나온 새로운 데이터를 발표하였으며, 이는 두경부암 환자들의 삶의 질이 크게 개선되었음을 보여줍니다.
연구의 주요 결과는 Multikine에 완전 반응한 환자의 95.1%가 삶의 질이 개선되었다고 보고했으며, 60%의 측정에서 100%의 개선이 있었습니다. 또한, 부분 반응 환자의 89.4%가 삶의 질 지표가 향상되었다고 보고하였습니다.
삶의 질 개선 사항은 다음과 같습니다:
- 두경부 통증의 감소 또는 제거
- 먹고, 마시고, 삼키는 능력 향상
- 자기 관리 능력 개선
- 정서적 웰빙 개선
이번 연구는 새로 진단된 국소 진행 두경부암 환자를 대상으로 진행된 가장 큰 연구로, Multikine 치료 그룹에서 45명의 객관적 조기 반응자가 있었으며, 대조군에서는 0명이었습니다. Multikine은 이제 최종 확인 등록 연구로 진행되고 있습니다.
CEL-SCI (NYSE: CVM) a publié de nouvelles données issues de son étude de Phase 3 sur Multikine dans la revue Pathology and Oncology Research, montrant des améliorations significatives de la qualité de vie pour les patients atteints de cancer de la tête et du cou.
Les résultats clés de l'étude ont révélé que 95,1% des répondants complets à Multikine ont signalé une amélioration de la qualité de vie, avec 100% d'amélioration dans 60% des mesures. De plus, 89,4% des répondants partiels ont rapporté des indicateurs de qualité de vie améliorés.
Les améliorations de la qualité de vie comprenaient:
- Réduction ou élimination de la douleur à la tête et au cou
- Meilleure capacité à manger, boire et avaler
- Amélioration des capacités d'autosoins
- Meilleur bien-être émotionnel
L'étude, qui était la plus grande jamais réalisée pour des patients récemment diagnostiqués avec un cancer de la tête et du cou localement avancé, a démontré 45 répondants précoces objectifs dans le groupe traité par Multikine contre zéro dans le groupe témoin. Multikine passe maintenant à une étude d'enregistrement final confirmatoire.
CEL-SCI (NYSE: CVM) hat neue Daten aus seiner Phase-3-Studie zu Multikine in der Fachzeitschrift Pathology and Oncology Research veröffentlicht, die signifikante Verbesserungen der Lebensqualität für Patienten mit Kopf- und Halskrebs zeigen.
Die wichtigsten Ergebnisse der Studie zeigten, dass 95,1% der vollständigen Responder auf Multikine eine verbesserte Lebensqualität berichteten, wobei 100% Verbesserung in 60% der Maße festgestellt wurde. Darüber hinaus berichteten 89,4% der teilweisen Responder von verbesserten Lebensqualitätsmetriken.
Die Verbesserungen der Lebensqualität umfassten:
- Reduzierung oder Beseitigung von Kopf- und Halsschmerzen
- Verbesserte Fähigkeit zu essen, zu trinken und zu schlucken
- Verbesserte Selbstpflegemöglichkeiten
- Besseres emotionales Wohlbefinden
Die Studie, die die größte je durchgeführte für neu diagnostizierte lokal fortgeschrittene Kopf- und Halskrebspatienten war, zeigte 45 objektive frühe Responder in der mit Multikine behandelten Gruppe im Vergleich zu null in der Kontrollgruppe. Multikine geht nun in eine endgültige bestätigende Registrierungstudie über.
- Strong efficacy data with 45 objective early responders vs. zero in control group
- 95.1% of complete responders showed QoL improvements
- Long-lasting benefits with QoL improvements sustained for over 3 years
- 89.4% of partial responders showed QoL improvements
- Advancement to final confirmatory Registration Study
- None.
Insights
CEL-SCI's newly published data from its Phase 3 Multikine trial represents a meaningful clinical advancement for head and neck cancer patients. The quality-of-life improvements are particularly impressive, with complete responders showing sustained benefits across 60% of measured parameters for over three years post-treatment.
What stands out is the 95.1% response rate among complete responders and 89.4% improvement rate among partial responders - metrics that matter tremendously in head and neck cancer, where treatment side effects can severely impact basic functions like eating, speaking, and swallowing. The objective response rate differential (45 responders in the Multikine group versus zero in the control) further validates the treatment's biological activity.
Publication in a peer-reviewed journal adds scientific credibility to these findings. The advancement to a final confirmatory Registration Study signals the company is progressing toward potential regulatory submission, though the path and timeline remain undefined.
For a micro-cap company (
The quality-of-life improvements documented in CEL-SCI's Multikine trial are clinically significant for head and neck cancer patients. Head and neck cancers and their treatments typically cause profound functional impairments - pain, difficulty swallowing, speaking, and eating - substantially diminishing patient quality of life.
Three aspects of this data are particularly noteworthy: First, the neoadjuvant approach (pre-surgical treatment) potentially preserves function before standard treatments cause additional damage. Second, the objective pathological responses (including 5 complete responders) suggest genuine tumor activity rather than symptomatic relief alone. Third, the sustained duration of benefits (3+ years) indicates lasting impact rather than temporary improvement.
The methodology appears robust, using validated EORTC quality-of-life instruments specific to both general cancer (QLQ-C30) and head/neck cancer (QLQ-H&N35). The comprehensive assessment across multiple functional domains provides a holistic view of patient benefit.
While these quality-of-life improvements are promising, the advancement to a final Registration Study suggests further confirmation is needed before potential approval. The immunotherapeutic approach represents a differentiated mechanism compared to current standard treatments, potentially offering a complementary strategy with fewer side effects than chemotherapy or radiation.
Data published in peer-reviewed scientific journal Pathology and Oncology Research
Quality of life improvements included reduction in or cessation of pain in the head and neck area, improvement or complete restoration in ability to eat, drink, and swallow, ability for selfcare including walking and using the toilet, and improved emotional wellbeing
Complete responders to Multikine treatment reported a
Multikine is headed into a final confirmatory Registration Study in head and neck cancer
“We are pleased that the wealth of data resulting from our completed Phase 3 study is now published in this international oncology journal,” stated CEL-SCI’s Chief Scientific Officer, Dr. Eyal Talor. “We believe the marked improvement in quality of life offered by Multikine neoadjuvant treatment appeared to have had a positive impact on patients’ quality of life, and in addition to its favorable safety profile, tolerability and efficacy, it is likely to improve adoption rates for Multikine following regulatory approval.”
The new, previously unpublished findings included the following patient quality of life data:
-
Quality of life (QoL) was assessed and validated through use of two instruments, EORTC QLQ-C30 and EORTC QLQ-H&N 35 across all clinical sites.
- EORTC QLQ-C30 is a 30-item questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related QoL of cancer patients.
- EORTC QLQ-H&N 35 is a questionnaire designed to assess the QoL of head and neck cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30.
- QoL variables were assessed at baseline, before and after the Multikine treatment, and periodically during long-term follow up. These assessments included questions regarding pain in the mouth, jaw, and throat, problems swallowing, sense of smell and taste, ability for selfcare and mobility including walking, using the toilet, shortness of breath, emotional wellbeing including irritability and depression, and many other daily health assessment factors.
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As a neoadjuvant therapy, patients were treated with Multikine before surgery. Pre-surgery objective early response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders (which included 5 complete responders following 3-weeks of Multikine treatment) in the Multikine treated + standard of care group and zero (none reported by investigators) in the control group, which received the standard of care treatments only (i.e., surgery plus radiotherapy or surgery plus chemoradiotherapy; with cisplatin as the chemotherapeutic agent per the study protocol and NCCN Guidelines).
-
95.1% of complete responders to Multikine reported improved QoL -
Complete responders reported a
100% (wherein all respondents scored the highest possible improvement from baseline) on60% (39/65) of the QoL measures assessed including sleep, appetite, pain, emotional state, condition of mouth, sense of smell and taste, and social, family and public interactions. - QoL results for complete responders were measured and sustained for over 3 years following treatment with Multikine.
-
89.4% of partial responders to Multikine (those exhibiting greater than30% reduction in tumor – confirmed by pathology at surgery) also reported improved assessed QoL measures from baseline.
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About the Completed Phase 3 and Upcoming Confirmatory Registration Study
Based on the exceptional efficacy results and favorable safety profile for Multikine in a cohort of patients in the Phase 3 study, the
Upon the Registration Study achieving full enrollment, CEL-SCI plans to seek early approval based on early tumor responses which were shown to correspond with survival rates. During the completed Phase 3 clinical trial, the 5-year overall survival rate of the target patient population (disease stage 3 and 4 patients who had no lymph node involvement and low PD-L1 tumor expression), which is the same population that will participate in the confirmatory study, increased to
About Pathology and Oncology Research (POR)
A
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, 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), given right after diagnosis and before surgery, 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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.
The Company has operations in
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, 2024. 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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