Aethlon Medical Reaches Key Milestone with Enrollment of the First Patient in (FPI) Its Hemopurifier® Cancer Trial in Australia
Aethlon Medical (AEMD) has enrolled the first patient in its Australian clinical trial of the Hemopurifier® at Royal Adelaide Hospital. The trial aims to evaluate safety, feasibility, and dosing in patients with solid tumors who haven't responded to anti-PD-1 therapies like Keytruda® or Opdivo®. The enrolled patient began a two-month run-in period on October 29, 2024, receiving anti-PD-1 therapy.
The trial will include 9-18 patients, focusing on the Hemopurifier's ability to remove tumor-produced Extracellular vesicles (EVs) from bloodstream. Currently, only about 30% of patients respond to anti-PD-1 therapies, and the company hopes to improve these response rates through their treatment.
Aethlon Medical (AEMD) ha arruolato il primo paziente nel suo studio clinico australiano sul Hemopurifier® presso l'Ospedale Royal Adelaide. Lo studio mira a valutare la sicurezza, la fattibilità e il dosaggio in pazienti con tumori solidi che non hanno risposto alle terapie anti-PD-1 come Keytruda® o Opdivo®. Il paziente arruolato ha iniziato un periodo di preparazione di due mesi il 29 ottobre 2024, ricevendo terapia anti-PD-1.
Lo studio includerà da 9 a 18 pazienti, concentrandosi sulla capacità del Hemopurifier di rimuovere le vescicole extracellulari (EVs) prodotte dai tumori dal flusso sanguigno. Attualmente, solo circa il 30% dei pazienti risponde alle terapie anti-PD-1, e la società spera di migliorare questi tassi di risposta attraverso il loro trattamento.
Aethlon Medical (AEMD) ha inscrito al primer paciente en su ensayo clínico australiano del Hemopurifier® en el Hospital Royal Adelaide. El ensayo tiene como objetivo evaluar la seguridad, la viabilidad y la dosificación en pacientes con tumores sólidos que no han respondido a terapias anti-PD-1 como Keytruda® u Opdivo®. El paciente inscrito comenzó un período de preparación de dos meses el 29 de octubre de 2024, recibiendo terapia anti-PD-1.
El ensayo incluirá de 9 a 18 pacientes, enfocándose en la capacidad del Hemopurifier para eliminar vesículas extracelulares (EVs) producidas por los tumores del torrente sanguíneo. Actualmente, solo alrededor del 30% de los pacientes responden a las terapias anti-PD-1, y la empresa espera mejorar estas tasas de respuesta a través de su tratamiento.
Aethlon Medical (AEMD)는 로열 애들레이드 병원에서 Hemopurifier®의 호주 임상 시험에 첫 번째 환자를 등록했습니다. 이 시험의 목적은 Keytruda® 또는 Opdivo®와 같은 항-PD-1 치료에 반응하지 않은 고형 종양 환자의 안전성, 타당성 및 용량을 평가하는 것입니다. 등록된 환자는 2024년 10월 29일부터 두 달간의 준비 기간을 시작하였으며, 이 기간 동안 항-PD-1 치료를 받고 있습니다.
이 임상 시험은 9~18명의 환자를 포함할 예정이며, Hemopurifier의 종양에서 생성된 세포외 소포(EVs)를 혈류에서 제거하는 능력에 중점을 둡니다. 현재 항-PD-1 치료에 반응하는 환자는 약 30%에 불과하며, 회사는 이 치료를 통해 반응률을 향상시키기를 희망하고 있습니다.
Aethlon Medical (AEMD) a inscrit le premier patient dans son essai clinique australien concernant le Hemopurifier® à l'Hôpital Royal Adelaide. L'essai vise à évaluer la sécurité, la faisabilité et le dosage chez des patients atteints de tumeurs solides qui n'ont pas réagi aux thérapies anti-PD-1 telles que Keytruda® ou Opdivo®. Le patient inscrit a commencé une période de préparation de deux mois le 29 octobre 2024, recevant une thérapie anti-PD-1.
L'essai comprendra de 9 à 18 patients, se concentrant sur la capacité du Hemopurifier à éliminer les vésicules extracellulaires (EVs) produites par les tumeurs du flux sanguin. Actuellement, seulement environ 30 % des patients réagissent aux thérapies anti-PD-1, et l'entreprise espère améliorer ces taux de réponse grâce à leur traitement.
Aethlon Medical (AEMD) hat den ersten Patienten in seiner australischen klinischen Studie des Hemopurifier® im Royal Adelaide Hospital eingeschlossen. Die Studie zielt darauf ab, die Sicherheit, Machbarkeit und Dosierung bei Patienten mit soliden Tumoren zu bewerten, die nicht auf anti-PD-1-Therapien wie Keytruda® oder Opdivo® angesprochen haben. Der eingeschlossene Patient begann am 29. Oktober 2024 mit einer zwei Monate dauernden Vorbereitungsphase, in der er eine anti-PD-1-Therapie erhielt.
Die Studie wird 9-18 Patienten umfassen und sich auf die Fähigkeit des Hemopurifier konzentrieren, vom Tumor erzeugte extrazelluläre Vesikel (EVs) aus dem Blutkreislauf zu entfernen. Derzeit sprechen nur etwa 30% der Patienten auf anti-PD-1-Therapien an, und das Unternehmen hofft, diese Ansprechrate durch ihre Behandlung zu verbessern.
- First patient enrollment achieved in Australian Hemopurifier® cancer trial
- Trial addresses large market opportunity with current anti-PD-1 therapies having only 30-40% response rates
- Preclinical studies showed Hemopurifier's effectiveness in reducing exosomes from cancer patient plasma samples
- Extended timeline for results with two-month run-in period before actual treatment
- Small trial size of only 9-18 patients
- Additional PMA study will be required after this trial
Insights
This clinical trial milestone marks a significant development in cancer immunotherapy. The study explores a novel approach to enhance anti-PD-1 therapy effectiveness through the Hemopurifier® device, targeting a critical unmet need in cancer treatment where only
The trial design is particularly noteworthy - incorporating a two-month run-in period allows for clear baseline measurements and proper assessment of the Hemopurifier's impact. The focus on Extracellular vesicles (EVs) represents an innovative mechanism to potentially overcome immunotherapy resistance, supported by preclinical evidence of the device's ability to reduce exosomes in cancer patient plasma.
While this is a small initial study (9-18 patients), its design as a safety and dose-finding trial is appropriate for this stage of development. The sequential cohort approach with varying treatment frequencies will help establish an optimal protocol for future larger-scale studies.
Patient Enrolled at the Cancer Clinical Trial Unit, CALHN, Royal Adelaide Hospital
Aethlon's Trial is a Safety, Feasibility, and Dose Finding Study of the Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies
The first patient completed screening activities confirming their eligibility on November 8, 2024, and has now entered a two-month run-in period, receiving anti-PD-1 therapy. During this time, concentrations of Extracellular vesicles (EVs) and anti-tumor T cell activity will be measured. If imaging after this two-month run-in period reveals no improvement in the patient's tumor, they will be treated with the Hemopurifier, followed by monitoring to identify decreases in EV concentrations and improvements in T cell anti-tumor activity.
"Enrollment 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 thrilled with the pre-screening activity being done to identify patients at Royal Adelaide, as well as the second site, Pindara Private Hospital in the
Currently, only approximately
The primary endpoint of the approximately nine to 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 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 raise additional capital on terms favorable to the Company, or at all; the Company's ability to successfully complete development of the Hemopurifier; the Company's ability to successfully demonstrate the utility of the Hemopurifier in patients with solid tumors in our oncology clinical trials; the Company's ability to achieve and realize the anticipated benefits from potential milestones; the Company's ability to obtain approval from the Ethics Committee of its third location in
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 is the primary endpoint of Aethlon Medical's (AEMD) Australian Hemopurifier trial?
When did Aethlon Medical (AEMD) enroll its first patient in the Australian Hemopurifier trial?
How many Hemopurifier treatments will patients receive in the AEMD trial?
What is the current response rate to anti-PD-1 therapies that AEMD's Hemopurifier aims to improve?
