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AEMD: Oncology EFS Open For Enrollment

·3 min read

By M. Marin

NASDAQ:AEMD

READ THE FULL AEMD RESEARCH REPORT

Aethlon Medical Inc. (NASDAQ:AEMD), a medical technology company engaged in developing products to diagnose and treat diseases in oncology and viral diseases that are life and organ threatening and not addressed with already approved treatments, reported 2Q FY 2021 results last night and provided a business update. The company’s lead product, the Hemopurifier®, is a blood filtration device that is designed to selectively remove harmful particles from the circulatory system. It works on existing equipment already installed in hospitals and clinics.

After receiving FDA approval of its IDE application to initiate an Early Feasibility Study (EFS) of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda), AEMD has commenced this first clinical trial in patients with advanced and/or metastatic head and neck cancer. The study is now open for enrollment. AEMD plans to enroll 10-12 subjects.

The primary endpoint of the study is safety, with exosome (see below) clearance an important secondary endpoint.

Secondary Outcome Measures:

• Levels of exosomes

• Tumor response

• Survival

Exosomes are nanosized particles released by cancer cells that promote the growth and spread of tumors, suppress the immune system and constrain the benefit of leading cancer therapies. Prior medical research and data suggest that exosomes play a key role in why some oncology patients fail to respond to treatment. Preclinical testing has demonstrated the ability of the Hemopurifier to remove tumor-derived exosomes, which could have utility in the treatment of cancer. The EFS will be the first real world-type evaluation of whether the Hemopurifier can successfully and safely remove exosomes from the blood.

AEMD’s COVID-19 EFS also is moving forward. AEMD intends to enroll up to 40 COVID-19 ICU patients at up to 20 domestic centers and is in the process of enrolling centers to participate in the study. Endpoints will include safety, reduction in circulating virus and clinical outcomes. AEMD will generate substantial data from the EFS.

Primary Outcome Measures:

• Safety and tolerability

• Incidence of device related adverse and/or serious adverse events

Secondary Outcome Measures:

• Length of stay in the ICU

• In-hospital mortality

• Days free of dependence on ventilator

• Evaluation of SARS-CoV-2 RNA levels & viral particle load post-Hemopurifier treatment

The company is well-capitalized, with $14.5 million in cash at the end of the September quarter and no debt.

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