Aethlon Medical Receives Second Ethics Committee Approval for Hemopurifier® Cancer Trial
Aethlon Medical (NASDAQ: AEMD) has received full ethics approval from the Bellberry Human Research Ethics Committee for a clinical trial of its Hemopurifier® at Pindara Private Hospital in Queensland, Australia. The trial will study the safety, feasibility, and dosing of the Hemopurifier in patients with solid tumors not responding to anti-PD-1 antibodies like Keytruda® or Opdivo®. This is the second ethics approval for the oncology trial in Australia, following approval at Royal Adelaide Hospital in June.
The trial aims to enroll 9-18 patients and will focus on safety as the primary endpoint. It will also explore the Hemopurifier's ability to reduce extracellular vesicles (EVs) in cancer patients' blood, which may improve response rates to anti-PD-1 therapies. The study results are expected to inform the design of a future Premarket Approval (PMA) study.
Aethlon Medical (NASDAQ: AEMD) ha ricevuto l'approvazione etica completa dal Bellberry Human Research Ethics Committee per un trial clinico del suo Hemopurifier® presso il Pindara Private Hospital nel Queensland, Australia. Il trial studierà la sicurezza, la fattibilità e il dosaggio dell'Hemopurifier nei pazienti con tumori solidi che non rispondono agli anticorpi anti-PD-1 come il Keytruda® o l'Opdivo®. Questa è la seconda approvazione etica per il trial oncologico in Australia, dopo l'approvazione ricevuta presso il Royal Adelaide Hospital a giugno.
Il trial punta ad arruolare 9-18 pazienti e si concentrerà sulla sicurezza come obiettivo primario. Esplorerà anche la capacità dell'Hemopurifier di ridurre vescicole extracellulari (EVs) nel sangue dei pazienti affetti da cancro, il che potrebbe migliorare i tassi di risposta alle terapie anti-PD-1. I risultati dello studio sono attesi per informare la progettazione di un futuro studio di approvazione prioritaria (PMA).
Aethlon Medical (NASDAQ: AEMD) ha recibido la aprobación ética completa del Bellberry Human Research Ethics Committee para un ensayo clínico de su Hemopurifier® en el Pindara Private Hospital en Queensland, Australia. El ensayo estudiará la seguridad, viabilidad y dosificación del Hemopurifier en pacientes con tumores sólidos que no responden a anticuerpos anti-PD-1 como Keytruda® u Opdivo®. Esta es la segunda aprobación ética para el ensayo oncológico en Australia, tras la aprobación en el Royal Adelaide Hospital en junio.
El ensayo tiene como objetivo inscribir de 9 a 18 pacientes y se centrará en la seguridad como criterio primario. También explorará la capacidad del Hemopurifier para reducir vesículas extracelulares (EVs) en la sangre de los pacientes con cáncer, lo que podría mejorar las tasas de respuesta a las terapias anti-PD-1. Los resultados del estudio se esperan para informar el diseño de un futuro estudio de aprobación previa al mercado (PMA).
Aethlon Medical (NASDAQ: AEMD)는 호주 퀸즈랜드에 있는 Pindara Private Hospital에서 Hemopurifier®의 임상 시험을 위해 Bellberry Human Research Ethics Committee의 전체 윤리 승인을 받았습니다. 이 시험은 Keytruda® 또는 Opdivo®와 같은 항-PD-1 항체에 반응하지 않는 고형 종양 환자들에서 Hemopurifier의 안전성, 실행 가능성 및 용량을 연구할 것입니다. 이는 호주에서 실시되는 종양학 시험에 대한 두 번째 윤리 승인으로, 6월에 Royal Adelaide Hospital에서의 승인이 있었습니다.
이 시험은 9-18명의 환자를 등록할 예정이며, 안전성을 주요 목표로 삼을 것입니다. 또한 Hemopurifier가 암 환자의 혈액에서 세포외 소포(EVs)를 줄이는 능력을 탐구하며, 이는 항-PD-1 치료에 대한 반응률 향상에 기여할 수 있습니다. 연구 결과는 향후 시장 승인(PMA) 연구의 설계를 안내할 것으로 기대됩니다.
Aethlon Medical (NASDAQ: AEMD) a reçu l'approbation éthique complète du Bellberry Human Research Ethics Committee pour un essai clinique de son Hemopurifier® à l'hôpital privé Pindara dans le Queensland, en Australie. L'essai étudiera la sécurité, la faisabilité et le dosage du Hemopurifier chez les patients atteints de tumeurs solides ne répondant pas aux anticorps anti-PD-1 tels que Keytruda® ou Opdivo®. C'est la deuxième approbation éthique pour l'essai oncologique en Australie, après l'approbation à l'hôpital Royal Adelaide en juin.
L'essai a pour objectif d'inscrire 9 à 18 patients et se concentrera sur la sécurité comme critère principal. Il explorera également la capacité du Hemopurifier à réduire les vésicules extracellulaires (EVs) dans le sang des patients atteints de cancer, ce qui pourrait améliorer les taux de réponse aux thérapies anti-PD-1. Les résultats de l'étude devraient servir à informer la conception d'une future étude de demande d'autorisation de mise sur le marché (PMA).
Aethlon Medical (NASDAQ: AEMD) hat die vollständige ethische Genehmigung vom Bellberry Human Research Ethics Committee für eine klinische Studie mit dem Hemopurifier® im Pindara Private Hospital in Queensland, Australien, erhalten. Die Studie wird die Sicherheit, Machbarkeit und Dosierung des Hemopurifiers bei Patienten mit solid tumors, die nicht auf Anti-PD-1-Antikörper wie Keytruda® oder Opdivo® ansprechen, untersuchen. Dies ist die zweite ethische Genehmigung für die Onkologie-Studie in Australien, nach der Genehmigung im Royal Adelaide Hospital im Juni.
Die Studie zielt darauf ab, 9-18 Patienten einzuschreiben und wird sich auf die Sicherheit als primäres Ziel konzentrieren. Außerdem wird die Fähigkeit des Hemopurifiers untersucht, extrazelluläre Vesikel (EVs) im Blut von Krebspatienten zu reduzieren, was die Ansprechrate auf Anti-PD-1-Therapien verbessern könnte. Die Studienergebnisse werden voraussichtlich dazu dienen, die Planung einer zukünftigen Marktzulassungsstudie (PMA) zu informieren.
- Second ethics committee approval received for Hemopurifier® cancer trial in Australia
- Trial to study Hemopurifier® in patients not responding to popular anti-PD-1 therapies
- Potential to improve response rates to anti-PD-1 therapies by removing tumor-produced extracellular vesicles
- Trial is still in early stages, focusing on safety and feasibility rather than efficacy
- Additional approvals required before patient enrollment can begin
- Only 30% of cancer patients currently respond to anti-PD-1 therapies, indicating a challenging market
Insights
This clinical trial approval for Aethlon's Hemopurifier® is a significant step in addressing the limitations of current immunotherapies. The study targets patients with solid tumors who don't respond to anti-PD-1 antibodies, a crucial unmet need given only
The Hemopurifier's mechanism of removing tumor-produced extracellular vesicles (EVs) from the bloodstream is innovative. If successful, it could potentially enhance the efficacy of existing immunotherapies, opening new avenues for combination treatments. The trial's design, focusing on safety and dose-finding, is a prudent approach before moving to larger efficacy studies.
Investors should note that while promising, this is an early-stage trial. The path to market is still long, requiring successful completion of this study and subsequent larger trials. However, positive results could significantly impact Aethlon's value proposition in the competitive oncology market.
The Hemopurifier trial addresses a critical challenge in immunotherapy: improving response rates in non-responders. By targeting extracellular vesicles (EVs), Aethlon is exploring a novel approach to overcome resistance mechanisms.
The trial's design is well-thought-out, with a two-month run-in period of PD-1 antibody monotherapy to clearly identify non-responders. The sequential cohort design with increasing Hemopurifier treatments (1, 2, or 3) will help determine the optimal dosing regimen.
Key aspects to watch are:
- Safety profile of the Hemopurifier in combination with immunotherapy
- Changes in EV concentrations post-treatment
- Any signs of improved tumor response or immune activation
Bellberry Human Research Ethics Committee Granted Full Ethics Approval to the Pindara Private Hospital for a Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies
"We are quite pleased that the BHREC accepted our responses to their thoughtful questions during their review and determined that our study meets the requirements of the National Statement application. Dr. Matos and his research team have a proven track record of enrollment in device trials in oncology patients that provides momentum to these trials," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "This is the second ethics committee approval we have received for our oncology trial in
Dr. LaRosa continued, "The next step is to receive approval from the Research Governance Office at each hospital which reviews indemnities and insurance. Once these approvals are obtained, Aethlon, in concert with our Australian Contract Research Organization, ReSQ, will conduct Site Initiation Visits (SIVs), after which patient enrollment may proceed."
Currently, only approximately
The primary endpoint of the approximate 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 and safety of the Hemopurifier in patients with solid tumors in our planned oncology clinical trials; the Company's ability to obtain the approval by the respective Ethics Boards of interested clinical trial sites in
Company Contact:
Jim Frakes
Interim Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
917-513-5303
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SOURCE Aethlon Medical, Inc.
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