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By M. Marin

NASDAQ:AEMD

READ THE FULL AEMD RESEARCH REPORT

Data Safety Monitoring Board Recommends Progressing Trial Without Modification

Aethlon Medical’s (NASDAQ:AEMD) current primary focus is on researching lead asset the Hemopurifier® therapeutic blood filtration system as a potential treatment in oncology. AEMD is conducting a basket oncology trial^[1] to study the impact of the Hemopurifier in patients with various solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment. Unfortunately, only about 30% of cancer patients who receive pembrolizumab (Keytruda^®) or nivolumab (Opdivo^®) treatment for solid tumors have lasting clinical responses. The company’s hypothesis is that using the Hemopurifier in conjunction with treatment of checkpoint inhibitors can increase the percent of patients who can benefit from combined treatment. The trial is intended to assess the Hemopurifier’s safety, feasibility, and optimal dosing.

This week AEMD announced that the independent Data Safety Monitoring Board (DSMB) overseeing its clinical trial has completed its scheduled safety review and recommended that the company progress the trial to the next patient cohort without modification. The DSMB is composed of independent medical experts in nephrology and oncology.

The first three patients in Cohort 1 have been treated, completing a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications. Participant #1 was treated with the Hemopurifier on January 29, 2025, for four hours on a single day and tolerated treatment without complications. Participants #2 and #3 received treatment in June 2025. All participants also completed a 7-day safety follow-up.

Primary trial endpoint is incidence of adverse events, clinically significant changes in safety laboratory tests of patients treated with the Hemopurifier

The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier-treated patients. The DSMB reviewed data from Cohort 1 in which no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported to date.

Cohort 2 enrollment has commenced; participants will receive 2-Hemopurifier treatments vs. 1 for Cohort 1 participants

Thus, following its evaluation, the DSMB reported finding no safety concerns related to the Hemopurifier and that the device continues to show a favorable safety and tolerability profile. AEMD has commenced enrollment for Cohort 2, in which participants will receive two Hemopurifier treatments over one week. Cohort 1 participants received one Hemopurifier treatment, as noted. The trial is planned to enroll about 9 to 18 participants and evaluate the safety and feasibility of administering the Hemopurifier at varying dosing intervals.

Checkpoint inhibitors are used to treat a broad range of tumor types. In fact, checkpoint inhibitors such as Keytruda® have been used to treat 25+ different types of cancer. 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. The goal is to build its database in oncology to help with the development of the Hemopurifier as an oncology treatment.

The study protocol had been expanded earlier to reflect evolving immunotherapy standard of care such as combination therapy. While initially the Hemopurifier was being evaluated as an added therapy in conjunction with Keytruda or Opdivo, the device is also now being evaluated as a treatment in conjunction with Keytruda or Opdivo in combination with other therapy. This is because Keytruda and other therapy are not only used as standalone treatment, but often used in combination with other therapies.

Company plans to open a similar trial in India

The ongoing trial is being conducted at three active clinical sites in Australia. AEMD also expects to commence a similar study in India. In June 2025, AEMD received formal approval from India’s Central Drugs Standard Control Organization (CDSCO) to initiate a trial at Medanta Medicity Hospital in India similar to the one being conducted in Australia. The trial in India will begin following a Site Initiation Visit (SIV) that Qualtran, Aethlon’s India-based CRO, will make.

AEMD expects to realize benefits from attractive economic incentives the Australian government provides for clinical development efforts and lower costs in India, where R&D expenses are substantially lower than in the U.S., according to management, and thereby maximize its R&D dollars. Australia offers an R&D tax incentives rebate program, which enables companies to receive a cash tax rebate of up to 43.5% on clinical trial-related R&D costs and is expected to help it reduce costs, lower risk, and accelerate time to market.

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