Aethlon Medical Treats First Patient in Australian Hemopurifier® Cancer Trial
Aethlon Medical (NASDAQ: AEMD) has achieved a significant milestone by treating the first patient with its Hemopurifier device in an Australian clinical trial. The trial focuses on patients with solid tumors who show stable or progressive disease during anti-PD-1 monotherapy treatments like Keytruda® or Opdivo®.
The first patient, who showed disease progression after two months of Nivolumab treatment, received a 4-hour Hemopurifier treatment on January 29, 2025, at the Royal Adelaide Hospital, tolerating the procedure without complications. The trial aims to enroll approximately 18 patients to assess safety, feasibility, and optimal dosing.
The Hemopurifier is designed to remove tumor-derived extracellular vesicles (EVs) from the bloodstream, potentially improving response rates to anti-PD-1 therapies, which currently only benefit 30-40% of patients. The study will evaluate different treatment intervals and analyze changes in EV concentrations to inform future Premarket Approval studies.
Aethlon Medical (NASDAQ: AEMD) ha raggiunto un traguardo significativo trattando il primo paziente con il suo dispositivo Hemopurifier in uno studio clinico in Australia. Lo studio si concentra su pazienti con tumori solidi che presentano una malattia stabile o in progressione durante i trattamenti di monoterapia anti-PD-1 come Keytruda® o Opdivo®.
Il primo paziente, che ha mostrato progressione della malattia dopo due mesi di trattamento con Nivolumab, ha ricevuto un trattamento di 4 ore con il Hemopurifier il 29 gennaio 2025, presso il Royal Adelaide Hospital, tollerando la procedura senza complicazioni. Lo studio intende arruolare circa 18 pazienti per valutare la sicurezza, la fattibilità e il dosaggio ottimale.
Il Hemopurifier è progettato per rimuovere le vescicole extracellulari derivate dai tumori (EV) dal flusso sanguigno, potenzialmente migliorando i tassi di risposta alle terapie anti-PD-1, che attualmente beneficiano solo il 30-40% dei pazienti. Lo studio valuterà diversi intervalli di trattamento e analizzerà le variazioni nelle concentrazioni di EV per informare i futuri studi di approvazione pre-commerciale.
Aethlon Medical (NASDAQ: AEMD) ha alcanzado un hito significativo al tratar al primer paciente con su dispositivo Hemopurifier en un ensayo clínico en Australia. El ensayo se enfoca en pacientes con tumores sólidos que presentan enfermedad estable o en progresión durante los tratamientos de monoterapia anti-PD-1 como Keytruda® u Opdivo®.
El primer paciente, que mostró progresión de la enfermedad después de dos meses de tratamiento con Nivolumab, recibió un tratamiento de 4 horas con el Hemopurifier el 29 de enero de 2025, en el Royal Adelaide Hospital, tolerando el procedimiento sin complicaciones. El ensayo tiene como objetivo inscribir aproximadamente a 18 pacientes para evaluar la seguridad, viabilidad y dosificación óptima.
El Hemopurifier está diseñado para eliminar vesículas extracelulares derivadas de tumores (EV) del torrente sanguíneo, mejorando potencialmente las tasas de respuesta a las terapias anti-PD-1, que actualmente solo benefician al 30-40% de los pacientes. El estudio evaluará diferentes intervalos de tratamiento y analizará los cambios en las concentraciones de EV para informar futuros estudios de aprobación previa al mercado.
Aethlon Medical (NASDAQ: AEMD)는 호주 임상 시험에서 Hemopurifier 장치를 사용하여 첫 번째 환자를 치료함으로써 중요한 이정표를 달성했습니다. 이 시험은 Keytruda® 또는 Opdivo®와 같은 항 PD-1 단일 요법 치료 중 안정성 또는 진행성 질병을 보이는 고형 종양 환자에 초점을 맞추고 있습니다.
첫 번째 환자는 Nivolumab 치료 후 두 달 만에 질병이 진행되어 2025년 1월 29일 Royal Adelaide Hospital에서 4시간 동안 Hemopurifier 치료를 받았으며, 절차를 합병증 없이 잘 견뎌냈습니다. 이 시험은 안전성, 실행 가능성 및 최적의 용량을 평가하기 위해 Approximately 18명의 환자를 등록할 계획입니다.
Hemopurifier는 종양 유래 세포외 소포(EV)를 혈류에서 제거하도록 설계되어 있으며, 현재 30-40%의 환자에게만 혜택을 주는 항 PD-1 요법에 대한 반응 비율을 개선할 수 있습니다. 이 연구는 다양한 치료 간격을 평가하고 EV 농도의 변화를 분석하여 향후 시장 승인 연구에 대한 정보를 제공할 것입니다.
Aethlon Medical (NASDAQ: AEMD) a atteint une étape significative en traitant le premier patient avec son dispositif Hemopurifier dans un essai clinique en Australie. L'essai se concentre sur les patients présentant des tumeurs solides montrant une maladie stable ou en progression pendant les traitements de monothérapie anti-PD-1 tels que Keytruda® ou Opdivo®.
Le premier patient, qui a montré une progression de la maladie après deux mois de traitement par Nivolumab, a reçu un traitement de 4 heures avec le Hemopurifier le 29 janvier 2025, à l'Hôpital Royal d'Adélaïde, tolérant la procédure sans complications. L'étude vise à inscrire environ 18 patients pour évaluer la sécurité, la faisabilité et la posologie optimale.
Le Hemopurifier est conçu pour éliminer les vésicules extracellulaires dérivées des tumeurs (EV) de la circulation sanguine, ce qui pourrait améliorer les taux de réponse aux thérapies anti-PD-1, qui bénéficient actuellement à seulement 30-40% des patients. L'étude évaluera différents intervalles de traitement et analysera les variations des concentrations d'EV pour informer les futures études d'approbation pré-commerciale.
Aethlon Medical (NASDAQ: AEMD) hat einen bedeutenden Meilenstein erreicht, indem der erste Patient in einer australischen klinischen Studie mit dem Hemopurifier-Gerät behandelt wurde. Die Studie konzentriert sich auf Patienten mit soliden Tumoren, die während der Monotherapie mit Anti-PD-1-Medikamenten wie Keytruda® oder Opdivo® eine stabile oder fortschreitende Erkrankung zeigen.
Der erste Patient, der nach zwei Monaten Nivolumab-Behandlung eine Krankheitsprogression zeigte, erhielt am 29. Januar 2025 eine 4-stündige Behandlung mit dem Hemopurifier im Royal Adelaide Hospital und tolerierte den Eingriff ohne Komplikationen. Die Studie zielt darauf ab, etwa 18 Patienten zu rekrutieren, um Sicherheit, Machbarkeit und optimale Dosierung zu bewerten.
Der Hemopurifier wurde entwickelt, um tumorabgeleitete extrazelluläre Vesikel (EVs) aus dem Blutkreislauf zu entfernen, was potenziell die Antwortraten auf Anti-PD-1-Therapien verbessern könnte, von denen derzeit nur 30-40% der Patienten profitieren. Die Studie wird verschiedene Behandlungsintervalle bewerten und Veränderungen der EV-Konzentrationen analysieren, um zukünftige Genehmigungsstudien vor dem Markt zu informieren.
- First patient successfully treated without complications in Australian clinical trial
- Trial addresses large market opportunity with current anti-PD-1 therapies only effective in 30-40% of patients
- Preclinical studies show Hemopurifier's ability to reduce cancer patient exosomes
- Extended timeline for full trial completion with 18-patient enrollment target
- Multiple regulatory approvals still required before commercialization
- Additional efficacy and safety studies needed for Premarket Approval
Insights
The treatment of the first patient in Aethlon's Australian trial marks a important advancement in addressing one of oncology's most pressing challenges: immunotherapy resistance. The trial's design is particularly noteworthy, incorporating a two-month run-in period that establishes a clear baseline for measuring the Hemopurifier's impact.
The focus on patients who progress during anti-PD-1 therapy is strategically significant, targeting an estimated 60-70% of patients who don't respond to standard immunotherapy. The Hemopurifier's approach of removing tumor-derived extracellular vesicles (EVs) represents a novel mechanism that could potentially overcome resistance to expensive immunotherapies like Keytruda® and Opdivo®.
The trial's structure, with sequential cohorts receiving 1, 2, or 3 treatments, is designed to establish both the optimal treatment frequency and provide mechanistic proof through EV concentration measurements. This data-driven approach will be important for:
- Determining the minimum effective dose
- Understanding the durability of EV reduction
- Establishing correlations between EV removal and immune response
The successful completion of the first treatment without complications is encouraging, but investors should note that this is an early-stage trial focused on safety and feasibility. The planned 18-patient study will need to demonstrate both safety and biological activity to support the subsequent PMA trial required for regulatory approval.
First Patient enrolled and treated at the Cancer Clinical Trial Unit, CALHN, Royal Adelaide Hospital
Aethlon Advances Hemopurifier® Study in Solid Tumors Not Responding to Anti-PD-1 Antibodies
The patient treated was determined to have progressive disease following a two-month "run -in" period of the anti-PD-1 drug Nivolumab. During this period, serial measurements of extracellular vesicles (EVs) and anti-tumor T cell activity were obtained. The patient was then treated with the Aethlon Hemopurifier for 4 hours on a single day and tolerated the procedure without complications. The patient will have follow-up safety visits, EV and T cell measurements as well as imaging for clinical response.
"Treatment of the first patient represents the achievement of a critical milestone for Aethlon Medical in the clinical development of the Hemopurifier in Oncology," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We are excited to receive the data from this first treatment cohort, anticipating insights into how the Hemopurifier may reduce tumor-derived extracellular vesicles and enhance T cell activity against tumors".
Currently, only approximately 30
The primary endpoint of the approximately 18-patient, safety, feasibility, and dose-finding trial is the incidence of adverse events and clinically significant changes in safety 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 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 the Hemopurifier®
The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation. The Hemopurifier is an extracorporeal device that is used in concert with a blood pump. The device incorporates plasma separation, size exclusion, and affinity binding to an affinity resin containing a plant lectin. Mannose on the surface of enveloped viruses and extracellular vesicles binds to the plant lectin within the device. Extracellular vesicles released from solid tumors have been implicated in the spread of cancers known as metastasis as well as in the resistance to immunotherapy and chemotherapeutic agents. Removal of enveloped viruses and extracellular vesicles has been observed in in vitro studies and in human subjects. The Hemopurifier holds a
About Aethlon Medical, Inc.
Aethlon Medical, Inc. is a publicly traded medical device company based in
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 include, without limitation, the number of patients who receive pembrolizumab or nivolumab that will have lasting clinical responses to these agents; the possibility of novel treatment strategies; how the Hemopurifier may reduce tumor-derived extracellular vesicles and enhance T cell activity against tumors; the efficacy of continued clinical trials. 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, 2023, 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 Executive Officer and 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
What are the primary endpoints of Aethlon Medical's (AEMD) Australian Hemopurifier trial?
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