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Aethlon Medical Reports Positive Results From an In Vitro Binding Study of Its Hemopurifier® in Removing Extracellular Vesicles From Cancer Patient Plasma
Translational Study Provides Pre-Clinical Evidence to Support The Design of a Phase 1 Study of the Hemopurifier In Cancer Patients With Solid Tumors Treated
About this update from Aethlon Medical, Inc.
[{"type":"text","content":"Translational Study Provides Pre-Clinical Evidence to Support The Design of a Phase 1 Study of the Hemopurifier In Cancer Patients With Solid Tumors Treated With Anti-PD-1 Antibodies\nSAN DIEGO, May 10, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced positive results from an in vitro binding study of its Hemopurifier® in removing extracellular vesicles (EVs) from plasma. The translational study provides pre-clinical evidence to support Aethlon's planned phase 1 safety, feasibility and dose-finding clinical trials of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.\n\n\"The positive data from this in vitro binding study of the Hemopurifier is an important step forward for Aethlon, ahead of the potential start of our planned phase 1 oncology trials in Australia and India,\" stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical. \"We have previously demonstrated that our Hemopurifier can reduce EVs isolated from cancer patient plasma when those EVs are placed in a buffer solution. However, ahead of our oncology study, we wanted to conduct a more robust translational study, specifically examining the removal of EVs and EVs with PD-L1 on their surface directly from plasma. To that end, we acquired small volumes of plasma from patients treated with anti-PD-1 antibodies from a third-party lab and ran the samples over a miniature version of our Hemopurifier. We then had the samples examined by Cellarcus Biosciences, Inc., an independent commercial lab with recognized expertise in EV quantification and phenotyping, by the widely accepted methodology of vesicle flow cytometry. This data was then analyzed by independent statisticians at NAMSA, the contract research organization (CRO) for our planned Australian oncology study.\"\nMr. Frakes concluded, \"The descriptive statistics from the CRO support the removal of EVs by the Hemopurifier directly from cancer patient plasma, although the small numbers of EVs bearing PD-L1 did not allow us to conclude a removal of this particular EV subset. We look forward to adding this data to our Clinical Invest...