Aethlon Medical报告癌症患者血液净化器试验的早期信号，显示第一队列的免疫和分子变化

Aethlon Medical, Inc. ("Aethlon" or the "Company") (NASDAQ:AEMD) today provided observations on the preliminary changes in extracellular vesicle (EV), microRNA and lymphocyte counts in the first patient cohort in its ongoing oncology clinical trial in Australia. The study is a safety, feasibility, and dose-finding trial evaluating the company's Hemopurifier (HP) in patients with cancer not responding to anti-PD-1 therapy.

We observed interesting directional changes in EV numbers, microRNAs and lymphocytes following a single Hemopurifier treatment in the three participants in the first cohort. Additional data from the subsequent two cohorts will help determine whether these observations are reproducible, and whether there is a dose response with additional Hemopurifier treatments in terms of the magnitude and duration of the changes.

Additional details of these early observations are provided below:

• EVs: Two of the three participants in the trial showed decreases in large EVs also known as microvesicles. EVs are nanoparticles that are involved in cell-to-cell communication and are implicated in the spread of cancer (metastasis), growth of new blood vessels to the tumor, (angiogenesis), cell death (apoptosis), and inhibition of the body's T cells, which are important for killing tumor cells.
  • Platelet Derived EVs: Decreases were observed in large and small platelet-derived EVs in two of the three patients.
  • EV PD-L1: Decreases in the subset of large EVs carrying PD-L1 were observed in all three participants during the Hemopurifier treatment. Persistently elevated counts of EVs with PD-L1 have been associated with lack of response to anti-PD-1 agents.
• MicroRNAs: Following a single 4-hour HP treatment, decreases were observed in seven out of ten miRNAs examined in two of the three participants. MicroRNAs are one component of the cargo of extracellular vesicles, previously reported to promote cancer growth and metastasis.
  
  
  
  The EV and microRNA levels typically returned to pre-Hemopurifier treatment levels between 1 - 3 weeks.
• Lymphocyte Counts:
  • Laboratory Ratios: After a single 4-hour-treament, improvements in laboratory ratios associated with responses to immunotherapy including Neutrophil, Lymphocyte, Monocyte, Lymphocyte, Lymphocyte, Albumin and Systemic Immune-Inflammation were observed in at least two participants.
• T cells and T cell subsets: Increases were noted in total T cell numbers, CD8 and CD4 T cell subsets, and tumor specific T cells (CD137 +ve) in participants following Hemopurifier treatment without a consistent pattern in terms of timing of improvement.

Important Caveats:

• We are making these observations on three patients with one participant withdrawing from the study after 1 week due to cancer progression and thus supplying only limited follow-up data.
• The small number of participants allows for only "directional" descriptive statistics and not formal statistical analyses.
• These participants received only a single Hemopurifier treatment and thus we cannot make any statements about "dose response" i.e., will changes be greater or more long lasting with more treatments.
• There is heterogeneity within the data in terms of a) the number of Hemopurifier treated patients who experienced changes in the variables of interest, b) the magnitude of the changes observed, and (c) the timing and duration of the laboratory changes observed.

We cannot make any correlation between the changes observed above and the clinical efficacy of the Hemopurifier in cancer. These observations are from an early feasibility study and should not be interpreted as evidence of clinical benefit or safety beyond the study parameters. Determinations of the presence or absence of clinical efficacy can only be determined in a larger premarket approval or PMA trial specifically designed with this as the primary endpoint.