By M. Marin
NASDAQ:AEMD
READ THE FULL AEMD RESEARCH REPORT
With approval from first location, AEMD will submit data to additional sites for participation in Hemopurifier oncology trials…
Aethlon Medical (NASDAQ:AEMD) provided a business update recently. With the company’s increased focus on researching the Hemopurifier® therapeutic blood filtration system as a potential treatment in oncology, AEMD intends to launch a basket oncology trial to study the impact of the Hemopurifier on a variety of cancerous tumors, following a recently completed in vitro binding study of relevant oncology targets in advance of planned clinical trials. The company recently reported positive results from the in vitro binding study supporting the potential for the Hemopurifier® to remove extracellular vesicles (EVs) directly from plasma.
The data from the in vitro binding study moving forward with Aethlon’s planned phase 1 clinical trials in Australia and India of the Hemopurifier in cancer patients and, importantly, enables the company to submit findings to medical sites interested in participating in the study. The Hemopurifier® is a therapeutic blood filtration system that can bind and remove harmful particles from blood, including EVs directly from cancer patient plasma, as noted.
CALHN granted full ethics approval for safety, feasibility & dose-finding study
AEMD has received approval for the Hemopurifier® cancer trial from the ethics committee of the Central Adelaide Local Health Network (CALHN), which has granted full ethics approval for Aethlon’s safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment. PD-1 (Programmed cell death protein 1), is a protein found on the cell surface that plays a role in inhibiting immune responses. This is an important step forward as the company continues to advance research and clinical development activities for the Hemopurifier.
The company next intends to add this data to its Clinical Investigator Brochure, which will then be submitted to the Ethics Committees at clinical sites that are interested in participating in the planned phase 1 oncology trials in Australia and India. Depending on how long it takes for the sites to review and potentially approve moving forward to participate in Aethlon’s phase 1 trial, we believe clinical efforts could begin in 2H24. AEMD had cash of about $9.1M as of June 25, 2024, to support its efforts, following a recent capital raise. The company also believes it has a sufficient supply of Hemopurifiers for its planned oncology trials.
If the study shows the Hemopurifier to be beneficial in multiple cancer types, the company believes the data will support the broad utility of the device. Moreover, by focusing on multiple cancers, the company has also expanded the opportunities for patient enrollment by including patients with a variety of solid tumors and can build a database to support regulatory approval. By including both Keytruda and Opdivo can also facilitate patient enrollments. The goal is to build its database in oncology to help with the development of the Hemopurifier as an oncology treatment.
Moreover, AEMD is also maintaining a trial studying the Hemopurifier as a treatment against life-threatening viral infections through its COVID-19 trial in India for COVID-19 patients admitted to the ICU. Separately, AEMD has indicated incoming inquiries regarding the Hemopurifier for treatment of H5N1 Avian Influenza (H5N1 HPAI). The Hemopurifier has demonstrated the ability to capture prior iterations of the H5N1 bird flu virus in in vitro experiments, but has not been tested against the current strain.
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