Aethlon Medical (NASDAQ:AEMD) CEO and CFO Jim Frakes provided an update on the company’s ongoing oncology clinical study in Australia, highlighting recent feedback from an independent Data Safety Monitoring Board (DSMB) and outlining the company’s near-term trial timeline.
Australian oncology trial targets patients failing anti-PD-1 immunotherapy
Frakes said Aethlon’s Australian trial is enrolling participants with solid tumors that are not responding to treatment regimens that include anti-PD-1 immunotherapy agents pembrolizumab (Keytruda) or nivolumab (Opdivo). He noted that while the drugs are widely used, “they, unfortunately, only help about 1/3 of the patients that are on these drugs.”
Three-cohort design aims to identify an optimal number of treatments
Frakes described a three-cohort structure, with three participants in each cohort:
- Cohort 1: each participant received a single Hemopurifier treatment.
- Cohort 2: each participant received two treatments in a week (e.g., Monday and Friday).
- Cohort 3: each participant is planned to receive three treatments in a week (Monday, Wednesday, Friday).
“Once data is analyzed from each cohort, we expect to learn a lot about the number of HP treatments that would be optimal for these types of cancer patients,” Frakes said.
DSMB recommends advancing to cohort three
Frakes said the DSMB reviewed safety data after three participants completed treatment in cohort two. The board met on March 23 and could have recommended either advancing to the third cohort or enrolling three additional participants in cohort two based on safety findings.
“I’m pleased to report that the DSMB recommended that we advance to cohort three,” Frakes said, adding that the company disclosed the decision in a press release.
Trial also evaluates exosome reduction and immune-related measures
While the trial’s primary endpoint is safety—measuring adverse events and safety laboratory changes—Frakes said the study is also designed to assess how many Hemopurifier treatments are needed to reduce extracellular vesicles (EVs), also known as exosomes, and whether changes in EV concentrations may improve the body’s ability to attack tumor cells.
He noted that the study rationale and design were recently published in the peer-reviewed journal BMJ Open, with a link available on the company’s website.
Frakes also referenced early signals from the first cohort. “In the first cohort, we reported favorable directional improvement in EV numbers and immune cell numbers that were observed in the cohort with the single HP treatment,” he said.
For cohort two, Frakes said the company expects EV and T cell data “within three weeks from completion of the eight-week follow-up time point in the last treated patient,” which he recalled was in late February. “Sometime this quarter, we should have the data from the second cohort that we can announce,” he said.
Enrollment timing and next steps
Looking ahead, Frakes said Aethlon has interested patients and is working with principal investigators at three hospitals in Australia to complete paperwork for cohort three. He emphasized that scheduling is a key operational nuance, because the Hemopurifier sessions must be coordinated with patients’ existing immunotherapy schedules.
“We need to time the three HP treatments to occur the week before that next drug treatment,” Frakes said, noting that Opdivo or Keytruda treatments are typically administered about every three weeks.
Asked how soon cohort three could be enrolled, Frakes said the company has “three in the queue” and additional interested patients, though some may drop out due to logistical timing constraints. He said he expects the cohort to be finished “this quarter.”
On the broader scientific premise, Frakes said it is “pretty widely known in the EV journals” that metastasis is communicated by EVs or exosomes, and argued that diminishing this process “should help the patients.”
Frakes said that over the next two to three years, success would include completing the current study, compiling data with the University of Sydney, publishing results, and submitting information to Australia’s Therapeutic Goods Administration (TGA). He added that the company would then pursue a larger efficacy study, selecting the number of Hemopurifier treatments based on what is learned in the current safety-focused trial, with the long-term goal of moving toward eventual approval.
About Aethlon Medical (NASDAQ:AEMD)
Aethlon Medical, Inc (NASDAQ: AEMD) is a clinical‐stage biotechnology company focused on developing novel immunotherapeutic medical devices to address life‐threatening diseases. The company’s lead product candidate, the Hemopurifier®, is an extracorporeal affinity device designed to remove circulating viruses and immunosuppressive exosomes from the bloodstream. By targeting glycosylated pathogens and exosomes, Aethlon aims to restore immune function and improve patient outcomes in oncology and infectious disease settings.
The Hemopurifier platform leverages proprietary lectin affinity technology to selectively bind and eliminate harmful particles without depleting healthy blood components.
