Aethlon Medical, Inc. Announces Positive Data Safety Monitoring Board Review and Recommendation to Advance to Next Clinical Trial Cohort
Aethlon Medical (Nasdaq: AEMD) announced positive safety review results from the independent Data Safety Monitoring Board (DSMB) for its ongoing clinical trial AEMD-2022-06 of the Aethlon Hemopurifier®. The trial is evaluating the device's safety and optimal dosing in cancer patients with stable or progressive disease while on Pembrolizumab or Nivolumab treatment.
The DSMB reviewed data from the initial three-patient cohort, who each received a single 4-hour Hemopurifier treatment, finding no safety concerns or serious adverse events. The board recommended advancing to Cohort 2, where participants will receive two Hemopurifier treatments over one week. The trial aims to enroll 9-18 patients across three Australian clinical sites.
The study targets patients among the 60-70% who don't respond well to anti-PD-1 immunotherapy, with findings intended to inform future Premarket Approval studies.
Aethlon Medical (Nasdaq: AEMD) ha annunciato risultati positivi dalla revisione sulla sicurezza condotta dal Data Safety Monitoring Board (DSMB) indipendente per il suo studio clinico in corso AEMD-2022-06 sul Aethlon Hemopurifier®. Lo studio valuta la sicurezza e il dosaggio ottimale del dispositivo in pazienti oncologici con malattia stabile o in progressione durante il trattamento con Pembrolizumab o Nivolumab.
Il DSMB ha esaminato i dati del primo gruppo di tre pazienti, ciascuno sottoposto a un singolo trattamento di 4 ore con l'Hemopurifier, riscontrando assenza di problemi di sicurezza o eventi avversi gravi. Il comitato ha raccomandato di procedere con il Gruppo 2, in cui i partecipanti riceveranno due trattamenti con Hemopurifier nell'arco di una settimana. Lo studio prevede di arruolare da 9 a 18 pazienti in tre centri clinici australiani.
Lo studio si concentra sui pazienti che fanno parte della percentuale del 60-70% che non rispondono adeguatamente all'immunoterapia anti-PD-1, con risultati destinati a guidare studi futuri per l'approvazione premessa di mercato.
Aethlon Medical (Nasdaq: AEMD) anunció resultados positivos de la revisión de seguridad realizada por la Junta Independiente de Monitoreo de Seguridad de Datos (DSMB) para su ensayo clínico en curso AEMD-2022-06 del Aethlon Hemopurifier®. El estudio evalúa la seguridad y la dosificación óptima del dispositivo en pacientes con cáncer con enfermedad estable o progresiva mientras reciben tratamiento con Pembrolizumab o Nivolumab.
El DSMB revisó los datos de la cohorte inicial de tres pacientes, quienes recibieron un único tratamiento de 4 horas con el Hemopurifier, encontrando ninguna preocupación de seguridad ni eventos adversos graves. La junta recomendó avanzar a la Cohorte 2, donde los participantes recibirán dos tratamientos con Hemopurifier durante una semana. El ensayo planea inscribir entre 9 y 18 pacientes en tres sitios clínicos australianos.
El estudio está dirigido a pacientes dentro del 60-70% que no responden adecuadamente a la inmunoterapia anti-PD-1, con resultados que pretenden informar futuros estudios para la aprobación previa a la comercialización.
Aethlon Medical (나스닥: AEMD)는 진행 중인 임상 시험 AEMD-2022-06에 대한 독립 데이터 안전성 모니터링 위원회(DSMB)의 긍정적인 안전성 검토 결과를 발표했습니다. 이 시험은 Pembrolizumab 또는 Nivolumab 치료를 받는 암 환자 중 안정적이거나 진행성 질환 환자를 대상으로 Aethlon Hemopurifier®의 안전성과 최적 용량을 평가하고 있습니다.
DSMB는 각각 4시간 동안 단일 Hemopurifier 치료를 받은 초기 3명 환자 집단의 데이터를 검토하여 안전성 문제나 심각한 이상 반응이 없음을 확인했습니다. 위원회는 1주일 동안 두 번의 Hemopurifier 치료를 받는 2차 집단으로 진행할 것을 권고했습니다. 본 임상 시험은 호주 내 3개 임상 기관에서 9~18명의 환자를 모집할 예정입니다.
이 연구는 항-PD-1 면역치료에 잘 반응하지 않는 60-70% 환자를 대상으로 하며, 향후 시판 전 승인 연구에 참고할 결과를 도출하는 것을 목표로 합니다.
Aethlon Medical (Nasdaq : AEMD) a annoncé des résultats positifs de la revue de sécurité menée par le Data Safety Monitoring Board (DSMB) indépendant pour son essai clinique en cours AEMD-2022-06 sur le Aethlon Hemopurifier®. L'essai évalue la sécurité et le dosage optimal de l'appareil chez des patients cancéreux présentant une maladie stable ou progressive sous traitement par Pembrolizumab ou Nivolumab.
Le DSMB a examiné les données de la première cohorte de trois patients, chacun ayant reçu un traitement unique de 4 heures avec l'Hemopurifier, ne détectant aucune préoccupation de sécurité ni événement indésirable grave. Le comité a recommandé de passer à la Cohorte 2, où les participants recevront deux traitements Hemopurifier sur une semaine. L'essai vise à recruter entre 9 et 18 patients dans trois centres cliniques australiens.
Cette étude cible les patients parmi les 60-70% qui ne répondent pas bien à l'immunothérapie anti-PD-1, avec des résultats destinés à orienter les futures études d'approbation préalable à la commercialisation.
Aethlon Medical (Nasdaq: AEMD) gab positive Sicherheitsergebnisse des unabhängigen Data Safety Monitoring Boards (DSMB) für die laufende klinische Studie AEMD-2022-06 des Aethlon Hemopurifier® bekannt. Die Studie bewertet die Sicherheit und optimale Dosierung des Geräts bei Krebspatienten mit stabiler oder fortschreitender Erkrankung unter Behandlung mit Pembrolizumab oder Nivolumab.
Das DSMB überprüfte die Daten der ersten Kohorte von drei Patienten, die jeweils eine einzelne 4-stündige Behandlung mit dem Hemopurifier erhielten, und stellte keine Sicherheitsbedenken oder schwerwiegenden unerwünschten Ereignisse fest. Das Gremium empfahl den Übergang zu Kohorte 2, in der die Teilnehmer zwei Hemopurifier-Behandlungen innerhalb einer Woche erhalten. Die Studie plant die Einschreibung von 9 bis 18 Patienten an drei klinischen Standorten in Australien.
Die Studie richtet sich an die 60-70% der Patienten, die nicht gut auf die Anti-PD-1-Immuntherapie ansprechen, mit Ergebnissen, die zukünftige Zulassungsstudien vor dem Marktstart informieren sollen.
- None.
- Early-stage trial focused only on safety and dosing, not yet proving efficacy
- Small initial cohort size of only three patients
- Full trial size remains relatively small at 9-18 patients
- Multiple future trials still required before potential market approval
Insights
Aethlon's Hemopurifier device passes safety review milestone, advancing to next clinical trial phase with no serious adverse events reported.
The successful Data Safety Monitoring Board (DSMB) review represents a critical developmental milestone for Aethlon's Hemopurifier device. The independent board's recommendation to advance to Cohort 2 without modifications confirms the favorable safety profile observed in the initial cohort of three patients, each receiving a single 4-hour treatment. Notably, no serious adverse events or dose-limiting toxicities were reported.
This extracorporeal device is being evaluated specifically for patients who don't respond adequately to checkpoint inhibitors like pembrolizumab (Keytruda®) and nivolumab (Opdivo®) - a significant unmet need affecting approximately
The trial design merits attention - beyond safety assessments, researchers are investigating whether the Hemopurifier can effectively reduce extracellular vesicle (EV) concentrations, potentially enhancing the body's natural tumor-fighting capabilities. This mechanistic investigation could provide valuable biomarker data to support the device's therapeutic potential.
This safety study is strategically positioned as a precursor to a future Premarket Approval (PMA) study required by regulators. With anticipated enrollment of 9-18 patients across three Australian clinical sites, this dose-finding study should provide critical data on optimal treatment parameters for subsequent efficacy trials. The clinical program appears methodically structured to address regulatory requirements while exploring the device's potential to address an important therapeutic gap in oncology.
The trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab", is being conducted to assess the Hemopurifier's safety, feasibility, and optimal dosing.
The DSMB- comprising independent medical experts in nephrology and oncology- reviewed data from the initial cohort of three participants, each of whom received a single 4-hour Hemopurifier treatment. Based on their evaluation, the board found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported.
"The DSMB's positive recommendation is encouraging and underscores the favorable safety profile observed to date in patients with cancer," according to Steven LaRosa, M.D, Chief Medical Officer of Aethlon Medical. "This marks a significant step forward in the clinical development program for the Hemopurifier in Oncology and brings the company closer to potentially addressing the significant unmet medical need for the approximately 60
Enrollment for Cohort 2 is now open. In this phase, participants will receive two Hemopurifier treatments over a one-week period at the study's three active clinical sites in
The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier- treated patients. In addition to safety monitoring, 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 findings are expected to inform the design of a future efficacy and safety, Premarket Approval (PMA), study required by regulatory authorities.
Aethlon Medical, Inc. remains committed to advancing the Hemopurifier for use in oncology and will continue to provide updates as the clinical trial progresses.
About the Hemopurifier®
The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles (EVs) from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects.
The Hemopurifier holds a
- The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and
- The treatment of life-threatening viruses not addressed with approved therapies.
The Hemopurifier is being developed under an open Investigational Device Exemption (IDE) for both indications.
About Aethlon Medical, Inc.
Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinical stage medical device company headquartered 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; device deficiencies or immediate complications; 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; development under IDE for indications; and/or the number of patients enrolled in each cohort. 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 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
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