By M. Marin
NASDAQ: AEMD
READ THE FULL AEMD RESEARCH REPORT
DSMB recommends AEMD progress clinical trial to the final third cohort
Aethlon Medical (NASDAQ: AEMD) announced today that the independent Data Safety Monitoring Board (DSMB) overseeing the clinical trial it is conducting to assess lead asset, the Aethlon Hemopurifier, as a potential treatment in oncology, has completed its safety review of the data from the participants in cohort 2. As we indicated in a recent report, there are a number of expected upcoming milestones, and today AEMD announced that it has reached two.
Upcoming expected milestones
- Announce Cohort 2 safety data ✓
- Board decision regarding progressing to Cohort 3 ✓
- Commence Cohort 3
- Complete Cohort 3
- Announce overall trial data
- Potentially advance to efficacy trial
The Hemopurifier is an investigational extracorporeal device designed to bind and remove harmful extracellular vesicles (EVs) from the blood. It has FDA Breakthrough Device designation for the treatment of people with advanced or metastatic cancer who are either unresponsive to or cannot tolerate standard of care therapy, and with cancer types in which exosomes are indicated in the development or severity of the disease, and also for life-threatening viruses that are not addressed with approved therapies. The company believes the Hemopurifier is the only device currently being evaluated to remove EVs.
The DSMB recommended that the trial progress to the final third cohort, indicating that "no safety concerns were noted with Hemopurifier device/procedure." Specifically, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier treatment have been reported to date.
Can Hemopurifier + standard of care therapies increase percent of patients who benefit?
The trial is a safety and dose-finding study. The trial will monitor any adverse events and clinically significant changes in treated patients who have solid tumors with stable or progressive disease following treatment with Keytruda®, Opdivo®, or combined therapy. Despite the strong success of these standard of care therapies, 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 these and with combination therapy can increase the percent of patients who benefit.
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. EVs are seen to contribute to metastasis and to suppress the immune system. Down the road, if the company’s current evaluation of the Hemopurifier in oncology proves beneficial, AEMD believes the device could support broader potential clinical application in a range of diseases. Excessive levels of PD-EVs (platelet-derived EVs) have been implicated in many diseases, including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, acute, and Long COVID.
The trial design includes three cohorts, and participants in the first two have already completed treatment. In cohort 1, participants received one Hemopurifier treatment during a one-week period. Cohort 2 participants received two treatments, and cohort 3 will receive three treatments during a one-week period. Enrollment for Cohort 3 is open, and AEMD already has a queue of people interested in participating. Analysis of the data generated from this study will potentially be used to inform the design of a subsequent efficacy and safety Premarket Approval (PMA) study to move toward regulatory approval.
Device has shown reduction in EVs and other harmful particles
The device has shown reduction in EVs and other harmful particles. Moreover, to-date over time 173 Hemopurifier treatments have been administered in 44 patients with no SAEs. Once Cohort 3 treatment is completed, AEMD plans to report data from the overall study and, depending on Cohort 3 data, potentially form a partnership to assist with funding a subsequent efficacy trial.
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