By M. Marin
NASDAQ:AEMD
READ THE FULL AEMD RESEARCH REPORT
Cohort 1 preliminary data looks promising regarding Hemopurifier’s potential as an oncology treatment but it is early in the study
Aethlon Medical (NASDAQ:AEMD) is conducting a basket oncology trial to study the impact of the Hemopurifier® therapeutic blood filtration system as a potential treatment 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 and / or combination therapy can increase the percent of patients who can benefit. The trial is intended to assess the Hemopurifier's safety, feasibility, and optimal dosing.
The company reported early preliminary data from Cohort 1 this week. Our takeaways are:
- Preliminary data is encouraging. It appears that the study is on track to support AEMD’s hypothesis that the Hemopurifier, in conjunction with standard of care treatment, can increase the percent of patients who benefit.
- Thus far, the data suggest the Hemopurifier decreases the levels of particles in the body that are associated with the spread – or metastasis – of cancer and suppresses the immune system.
- Levels of certain of these harmful particles typically returned to pre-treatment levels 1-3 weeks after treatment ended, suggesting a potential benefit to patients while being treated.
- The study is designed to examine whether an increased number of Hemopurifier treatments can help extend positive patient responses.
- The company’s goal is to build its database supporting development of the Hemopurifier as an oncology treatment and this data appears to support that goal.
- It will be important to monitor whether these observations are reproducible as the study progresses, as it is early in the clinical trial to draw definitive conclusions and the data from Cohort 1 is not statistically significant.
Cohort 2 will produce additional data around dosing, patient responses
Reflecting preliminary data analysis, AEMD is encouraged that the study is on track to support its above-noted hypothesis that the Hemopurifier, in conjunction with checkpoint inhibitor or combined therapy treatment, can increase the percent of patients who can benefit from standard of care treatment and improve overall patient outcomes. Thus far, the trial data suggest that the Hemopurifier does, in fact, improve extracellular vesicles (EVs), extracellular MicroRNAs, and T cell counts. EVs are nanoparticles that are involved in cell-to-cell communication and associated with the spread or metastasis of cancer, as well as with the growth of new blood vessels to the tumor, cell death, and inhibition of T cells. T cells are critical for killing tumor cells.
The study design is for Cohort 2 participants to receive two Hemopurifier treatments over one week to help determine whether there is a dose response with additional Hemopurifier treatments in terms of the magnitude and duration of the changes.
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