Innovative Medical Technology Advances with First Patient Enrollments
Aethlon Medical (NASDAQ: AEMD) announced enrollment of its first patient in an Australian clinical trial for the Hemopurifier®, a device designed to combat cancer and viral infections. The trial focuses on patients with solid tumors showing stable or progressive disease during anti-PD-1 therapy. The first patient, enrolled on October 29, 2024, at Royal Adelaide Hospital, will undergo a two-month run-in period receiving anti-PD-1 therapy before potential Hemopurifier treatment. The trial aims to improve upon current 30-40% response rates to anti-PD-1 therapies by removing tumor-produced EVs from the bloodstream. The study will involve 9-18 patients and evaluate safety, feasibility, and optimal treatment intervals.
Aethlon Medical (NASDAQ: AEMD) ha annunciato l'arruolamento del suo primo paziente in un trial clinico australiano per l'Hemopurifier®, un dispositivo progettato per combattere il cancro e le infezioni virali. Lo studio si concentra su pazienti con tumori solidi che mostrano malattia stabile o in progressione durante la terapia anti-PD-1. Il primo paziente, arruolato il 29 ottobre 2024, presso il Royal Adelaide Hospital, seguirà un periodo preliminare di due mesi ricevendo terapia anti-PD-1 prima di un possibile trattamento con l'Hemopurifier. L'obiettivo dello studio è migliorare gli attuali tassi di risposta del 30-40% alle terapie anti-PD-1 rimuovendo gli EV prodotti dai tumori dal flusso sanguigno. Lo studio coinvolgerà da 9 a 18 pazienti e valuterà sicurezza, fattibilità e intervalli di trattamento ottimali.
Aethlon Medical (NASDAQ: AEMD) anunció la inscripción de su primer paciente en un ensayo clínico australiano para el Hemopurifier®, un dispositivo diseñado para combatir el cáncer y las infecciones virales. El ensayo se centra en pacientes con tumores sólidos que presentan enfermedad estable o en progresión durante la terapia anti-PD-1. El primer paciente, inscrito el 29 de octubre de 2024, en el Royal Adelaide Hospital, pasará por un periodo de preparación de dos meses recibiendo terapia anti-PD-1 antes de un posible tratamiento con Hemopurifier. El objetivo del ensayo es mejorar las tasas de respuesta actuales del 30-40% a las terapias anti-PD-1 eliminando las EV producidas por los tumores del torrente sanguíneo. El estudio involucrará de 9 a 18 pacientes y evaluará la seguridad, la viabilidad y los intervalos óptimos de tratamiento.
Aethlon Medical (NASDAQ: AEMD)는 암과 바이러스 감염에 맞서 싸우기 위해 설계된 장치인 Hemopurifier®의 호주 임상 시험에서 첫 번째 환자를 등록했다고 발표했습니다. 이 시험은 anti-PD-1 치료 중 안정적이거나 진행 중인 질환을 보이는 고형 종양 환자에 초점을 맞추고 있습니다. 첫 번째 환자는 2024년 10월 29일 로열 애들레이드 병원에서 등록되었으며, Hemopurifier 치료 가능성 전에 anti-PD-1 치료를 받는 두 달의 사전 준비 기간을 거칠 것입니다. 이 시험의 목표는 종양에서 생성된 EV를 혈류에서 제거하여 현재 anti-PD-1 치료에 대한 30-40%의 반응률을 개선하는 것입니다. 이 연구는 9-18명의 환자를 대상으로 하며 안전성, 실행 가능성 및 최적의 치료 간격을 평가할 것입니다.
Aethlon Medical (NASDAQ: AEMD) a annoncé l'inscription de son premier patient dans un essai clinique en Australie pour le Hemopurifier®, un dispositif conçu pour lutter contre le cancer et les infections virales. L'essai se concentre sur des patients présentant des tumeurs solides montrant une maladie stable ou en progression lors d'une thérapie anti-PD-1. Le premier patient, inscrit le 29 octobre 2024 au Royal Adelaide Hospital, sera soumis à une période préparatoire de deux mois durant laquelle il recevra une thérapie anti-PD-1 avant un traitement potentiel avec le Hemopurifier. L'objectif de l'essai est d'améliorer les taux de réponse actuels de 30-40 % aux thérapies anti-PD-1 en éliminant les EV produites par les tumeurs de la circulation sanguine. L'étude impliquera 9 à 18 patients et évaluera la sécurité, la faisabilité et les intervalles de traitement optimaux.
Aethlon Medical (NASDAQ: AEMD) gab bekannt, dass der erste Patient in einer australischen klinischen Studie für den Hemopurifier®, ein Gerät zur Bekämpfung von Krebs und Virusinfektionen, aufgenommen wurde. Die Studie konzentriert sich auf Patienten mit soliden Tumoren, die während der Anti-PD-1-Therapie eine stabile oder fortschreitende Erkrankung zeigen. Der erste Patient wurde am 29. Oktober 2024 im Royal Adelaide Hospital aufgenommen und wird zwei Monate lang eine Vorlaufzeit erhalten, in der er die Anti-PD-1-Therapie erhält, bevor er möglicherweise mit dem Hemopurifier behandelt wird. Ziel der Studie ist es, die gegenwärtigen Ansprechquoten von 30-40 % auf die Anti-PD-1-Therapien zu verbessern, indem tumorproduzierte EVs aus dem Blutstrom entfernt werden. Die Studie wird 9-18 Patienten einbeziehen und die Sicherheit, Durchführbarkeit sowie optimale Behandlungsintervalle evaluieren.
- First patient enrolled in Australian clinical trial, marking significant progress in Hemopurifier development
- Technology potentially addresses low response rates (30-40%) to current anti-PD-1 therapies
- Pre-clinical studies showed successful removal of harmful exosomes from biological fluids
- Small trial size of only 9-18 patients indicates early-stage development
- Extended two-month run-in period required before actual treatment can begin
- Multiple regulatory approvals still needed before commercialization
Insights
The enrollment of the first patient in Aethlon Medical's Hemopurifier trial represents a significant milestone in addressing treatment resistance in cancer immunotherapy. The trial targets a important market gap, as only
The trial design is particularly robust, with a two-month run-in period allowing for clear before-and-after comparisons of EV concentrations and T cell activity. With 9-18 patients and multiple treatment cohorts, the study will provide valuable dose-response data to inform future PMA studies. However, investors should note that the small market cap of
Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - November 12, 2024) - Investorideas.com, a go-to investing platform, releases an industry snapshot looking at the future of medical technology as first patients are enrolled in potential breakthrough trials, featuring Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.
Read the full article on Investorideas.com
https://www.investorideas.com/News/2024/biotech/11120AEMD-First-Patient-Enrollments.asp
According to Statista.com, "The Medical Technology market, which encompasses various markets, including Medical Devices, is anticipated to witness significant revenue growth in the coming years."
"By 2024, the market is projected to reach a staggering US
As medical technology companies announce first patient enrollment, they take a significant step forward to the goal of bringing their technology to market.
Yesterday, Aethlon Medical, Inc. (NASDAQ: AEMD) announced a key milestone with enrollment of the first patient in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The patient was enrolled on October 29, 2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia.
The Hemopurifier is an 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.
From the news: 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 Gold Coast. We are grateful to the patient for consenting to be part of this study. This trial is our initial step in determining if the Hemopurifier treatment can improve upon the 30
From the news: 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.
On November 4th, Royal Philips, a global leader in health technology, announced enrollment of the first patient in the US THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy catheter developed by Philips, that integrates two critical PAD treatments into a single device. Procedures that previously required the use of two different devices can now be performed in a single procedure using a single device, simplifying workflows and procedures and potentially reducing the risk and improving outcomes for patients who might otherwise face multiple complex interventions.
From the news: The Cardiovascular Institute of the South in Louisiana recently completed the first case using the new laser catheter. The care team there successfully treated a 78-year-old male with peripheral vascular disease using the Philips device.
"Developing and driving clinical evidence is crucial to improving care and guiding the adoption of new technologies like the Philips laser atherectomy and lithotripsy system," said Drs. Craig Walker, Pradeep Nair, and McCall Walker of Cardiovascular Institute of the South in Louisiana. "This trial will provide essential data to demonstrate how this combined approach can optimize procedural efficiency and patient outcomes in treating challenging calcified lesions."
From the news: This ground-breaking first procedure not only marks the launch of the THOR IDE trial. It also showcases how this innovative new technology, which resulted from Philips' powerful in-house development capabilities, can ease the patient experience by streamlining complex interventions into a single procedure, potentially reducing the need for multiple interventions and hospital visits.
From the news: The goal of this pivotal study is to evaluate the safety and efficacy of using this unique laser device - a first-of-its-kind solution that integrates laser atherectomy and intravascular lithotripsy in a single device to treat complex, calcified lesions in a single procedure for patients with peripheral artery disease (PAD), restoring blood flow to their legs.
On October 15th, Microbot Medical Inc., a developer of the innovative LIBERTY® Endovascular Robotic Surgical System, announced that it has successfully completed enrollment and follow up for all patients in its ACCESS-PVI human clinical trial. The Company remains on track to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by of the end of 2024.
The Company also announced that it is accelerating its go-to-market strategy. It expects to begin building out the commercial infrastructure, including the hiring of a seasoned healthcare executive to lead its sales efforts, upon the FDA clearance, which is expected during 2Q 2025.
This news follows up on developments since its first patient announcement in July when Microbot announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women's Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, as part of the Company's pivotal human clinical trial.
From the news: The clinical trial at BWH was led by Dr. Dmitry Rabkin, MD, PhD, Assistant Chief, Division of Angiography & Interventional Radiology, who also performed this first human case. The trial is part of the Investigational Device Exemption ("IDE") for LIBERTY®, and the Company expects its results will support the future submission to the FDA and subsequent commercialization.
"Enrolling the first patient in our pivotal human clinical trial is a significant milestone for the Company, and an important step on our journey to bring LIBERTY® to U.S. physicians," commented Juan Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical. "We are very pleased with the rapid pace of site activation, and I'm looking forward to enrolling additional patients in the near future."
Earlier this year BD (Becton, Dickinson and Company), a leading global medical technology company, announced the enrollment of the first patient in the investigational device exemption (IDE) study, "AGILITY," which will assess the safety and effectiveness of the BD Vascular Covered Stent for the treatment of Peripheral Arterial Disease (PAD).
The investigational Vascular Covered Stent is a self-expanding, low profile, polytetrafluoroethylene encapsulated nitinol implant. It is deployed from a delivery system that provides controlled stent release.
"When we're addressing advanced PAD, a self-expanding covered stent can play an important role," said Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and National Principal Investigator of the AGILITY study. "We need a stent that can track to the lesion, apposes the vessel wall and ultimately provides long-term durability. We're excited to see how this technology performs."
From the news: According to BD, the global, prospective, multi-center, single-arm, non-randomized AGILITY clinical study will include 315 patients at up to 40 clinical study sites across the United States, Europe, Australia and New Zealand. Follow-up for all treated patients will be performed at various points after treatment - starting at one month and ending at 36 months.
Medical technology and devices offer a different approach to health than pharmaceuticals, and as is the case with Aethlon Medical, Inc. (NASDAQ: AEMD) and its Hemopurifier in Oncology, it offers a potential solution when other treatment has failed.
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FAQ
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