Aethlon Receives Ethics Committee Approval for Hemopurifier® Cancer Trial in India
Aethlon Medical (Nasdaq: AEMD) has received full ethics approval from the Medanta Institutional Ethics Committee (MIEC) for its Hemopurifier® cancer trial in India. The trial, focusing on safety, feasibility, and dose-finding, will involve cancer patients with solid tumors not responding to anti-PD-1 antibodies like Keytruda® or Opdivo®. The study, to be conducted at Medanta Medicity Hospital, aims to evaluate the Hemopurifier as a treatment option for multiple tumor types.
The Hemopurifier is designed to remove tumor-produced extracellular vesicles (EVs) from the bloodstream, potentially improving response rates to anti-PD-1 therapies. The trial will involve 9-18 patients and monitor safety, adverse events, and changes in EV concentrations. Results are expected to inform future oncology efficacy trials and contribute to a subsequent Premarket Approval study.
Aethlon Medical (Nasdaq: AEMD) ha ricevuto l'approvazione etica completa dal Comitato Etico Istituzionale Medanta (MIEC) per la sua trial sul trattamento del cancro con Hemopurifier® in India. La sperimentazione, incentrata sulla sicurezza, fattibilità e ricerca della dose, coinvolgerà pazienti oncologici con tumori solidi non reattivi agli anticorpi anti-PD-1 come Keytruda® o Opdivo®. Lo studio, che si svolgerà presso il Medanta Medicity Hospital, ha l'obiettivo di valutare l'Hemopurifier come opzione terapeutica per diversi tipi di tumore.
L'Hemopurifier è progettato per rimuovere le vescicole extracellulari (EV) prodotte dai tumori dal flusso sanguigno, con il potenziale di migliorare i tassi di risposta alle terapie anti-PD-1. La sperimentazione coinvolgerà 9-18 pazienti e monitorerà la sicurezza, gli eventi avversi e le variazioni nelle concentrazioni di EV. I risultati sono attesi per informare futuri trial sull'efficacia oncologica e contribuire a uno studio successivo per l'approvazione pre-commerciale.
Aethlon Medical (Nasdaq: AEMD) ha recibido la aprobación ética completa del Comité de Ética Institucional de Medanta (MIEC) para su ensayo clínico de Hemopurifier® en el tratamiento del cáncer en India. El ensayo, que se centra en la seguridad, factibilidad y la búsqueda de dosis, involucrará a pacientes con cáncer con tumores sólidos que no responden a anticuerpos anti-PD-1 como Keytruda® u Opdivo®. El estudio, que se llevará a cabo en el Hospital Medanta Medicity, tiene como objetivo evaluar el Hemopurifier como una opción terapéutica para múltiples tipos de tumores.
El Hemopurifier está diseñado para eliminar las vesículas extracelulares (EV) producidas por los tumores del torrente sanguíneo, lo que podría mejorar las tasas de respuesta a las terapias anti-PD-1. El ensayo involucrará a 9-18 pacientes y monitorizará la seguridad, los eventos adversos y los cambios en las concentraciones de EV. Se espera que los resultados informen sobre futuros ensayos de eficacia oncológica y contribuyan a un estudio posterior de aprobación previa al mercado.
Aethlon Medical (Nasdaq: AEMD)는 인도의 Hemopurifier® 암 시험에 대해 Medanta 기관 윤리 위원회(MIEC)로부터 전체 윤리 승인을 받았습니다. 이 시험은 안전성, 실행 가능성 및 용량 확인에 중점을 두며, 키트루다(Keytruda®)나 옵디보(Opdivo®)와 같은 항-PD-1 항체에 반응하지 않는 고형 종양 환자들을 포함할 예정입니다. Medanta Medicity 병원에서 진행될 이 연구는 Hemopurifier가 여러 유형의 종양에 대한 치료 옵션으로서의 평가를 목표로 하고 있습니다.
Hemopurifier는 종양에서 생성된 세포외 소포(EV)를 혈류에서 제거하도록 설계되어 항-PD-1 요법에 대한 반응률을 개선할 가능성이 있습니다. 이 시험은 9-18명의 환자를 포함하고 안전성, 부작용 및 EV 농도의 변화를 모니터링할 것입니다. 결과는 향후 종양학 효능 시험에 대한 정보를 제공하고, 이후의 시장 승인 연구에 기여할 것으로 예상됩니다.
Aethlon Medical (Nasdaq: AEMD) a reçu l'approbation éthique complète du Comité d'Éthique Institutionnel de Medanta (MIEC) pour son essai clinique Hemopurifier® sur le cancer en Inde. L'essai, axé sur la sécurité, la faisabilité et la recherche de dosage, impliquera des patients atteints de cancer ayant des tumeurs solides non réagissant aux anticorps anti-PD-1 comme Keytruda® ou Opdivo®. L'étude, qui sera menée à l'hôpital Medanta Medicity, vise à évaluer l'Hemopurifier comme option de traitement pour plusieurs types de tumeurs.
L'Hemopurifier est conçu pour éliminer les vésicules extracellulaires (EV) produites par les tumeurs du flux sanguin, ce qui pourrait améliorer les taux de réponse aux thérapies anti-PD-1. L'essai impliquera 9 à 18 patients et surveillera la sécurité, les événements indésirables et les variations des concentrations d'EV. Les résultats devraient éclairer les futurs essais d'efficacité oncologique et contribuer à une étude d'approbation préalable au marché.
Aethlon Medical (Nasdaq: AEMD) hat die vollständige ethische Genehmigung des Medanta Institutional Ethics Committee (MIEC) für seine Hemopurifier® Krebsstudie in Indien erhalten. Die Studie, die sich auf Sicherheit, Machbarkeit und Dosissuche konzentriert, wird Krebspatienten mit soliden Tumoren umfassen, die nicht auf Anti-PD-1-Antikörper wie Keytruda® oder Opdivo® ansprechen. Die Studie, die im Medanta Medicity Hospital durchgeführt wird, zielt darauf ab, den Hemopurifier als Behandlungsoption für mehrere Tumorarten zu bewerten.
Der Hemopurifier wurde entwickelt, um vom Tumor produzierte extrazelluläre Vesikel (EVs) aus dem Blutkreislauf zu entfernen, was möglicherweise die Ansprechrate auf Anti-PD-1-Therapien verbessert. Die Studie wird 9-18 Patienten einbeziehen und Sicherheit, unerwünschte Ereignisse und Änderungen der EV-Konzentrationen überwachen. Die Ergebnisse werden voraussichtlich zukünftige Wirksamkeitsstudien in der Onkologie informieren und zu einer nachfolgenden Zulassungsstudie beitragen.
- Received full ethics approval for Hemopurifier® cancer trial in India
- Trial aims to evaluate Hemopurifier as a treatment option for multiple tumor types
- Hemopurifier designed to remove tumor-produced extracellular vesicles, potentially improving anti-PD-1 therapy response rates
- Trial results expected to inform future oncology efficacy trials and contribute to Premarket Approval study
- Only approximately 30% of cancer patients receiving pembrolizumab or nivolumab for solid tumors have lasting clinical responses
Insights
This ethics committee approval for Aethlon's Hemopurifier® trial in India is a significant milestone in advancing cancer treatment research. The study aims to address the low response rates (
- The trial will assess safety and feasibility in patients with solid tumors not responding to anti-PD-1 antibodies.
- It explores the potential of Hemopurifier® to remove EVs and potentially enhance immune response against tumors.
- The study design, involving 1-3 treatments over a week, could provide important data on optimal dosing.
This research could pave the way for a novel approach to improve immunotherapy efficacy, potentially benefiting a broader range of cancer patients.
The Hemopurifier® trial presents an innovative approach to tackle a major challenge in cancer immunotherapy. By targeting EVs, it addresses a key mechanism of resistance to anti-PD-1 therapies. Notable aspects:
- The focus on patients with stable or progressive disease during anti-PD-1 monotherapy targets a critical unmet need.
- The trial's design, assessing both safety and EV concentration changes, could provide valuable insights into the treatment's mechanism of action.
- Collaboration with experienced clinicians at Medanta Hospital enhances the study's credibility.
If successful, this approach could potentially revolutionize treatment strategies for solid tumors resistant to current immunotherapies, offering hope to patients with options.
This ethics approval marks a positive development for Aethlon Medical (NASDAQ: AEMD). Key financial implications:
- Expansion into the Indian market could potentially broaden the company's global footprint and access to a large patient population.
- The trial's focus on improving efficacy of existing therapies like Keytruda® and Opdivo® could position Hemopurifier® as a complementary treatment, potentially expanding its market potential.
- Success in this trial could lead to further studies and potential commercialization, significantly impacting Aethlon's future revenue streams.
However, investors should note that as an early-stage trial, significant risks remain, including potential safety issues or lack of efficacy. The company's financial performance will likely depend heavily on the outcome of this and subsequent trials.
Aethlon Medical Granted Full Ethics Approval from the Medanta Institutional Ethics Committee for a Safety, Feasibility, and Dose Finding Study of its Hemopurifier® in Cancer Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies
"The approval from the MIEC, coming closely on the heels of our two ethics committee approvals in
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The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the PD-1 therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.
About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a
Additional information can be found at www.AethlonMedical.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to successfully complete development of the Hemopurifier and to successfully demonstrate the utility of the Hemopurifier in patients with solid tumors in our planned oncology clinical trials; the Company's ability to recruit patients for and manage its clinical trials and studies; the results of the safety, feasibility and dose finding study; unforeseen changes in regulatory requirements; and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2024, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
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SOURCE Aethlon Medical, Inc.
FAQ
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