By M. Marin
Aethlon Medical Inc. (NASDAQ:AEMD) is 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 are not addressed with already approved treatments. 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.
The Hemopurifier has received FDA “Breakthrough Device” designation for the treatment of
• patients with advanced or metastatic cancer that are unresponsive to or intolerant of standard of care therapy and/or where exosomes have been shown to contribute to the disease development and/or severity; and
• patients with life-threatening viruses that approved therapies do not address.
The FDA has also approved AEMD’s 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 plans to enroll 10-12 subjects at the UPMC Hillman Cancer Center in Pittsburgh. The primary endpoint of the study will be safety. Secondary endpoints include measures of exosome clearance and characterization, as well as response and survival rates. Management believes the Hemopurifier holds the potential to become an adjunct treatment along with Keytruda.
Moreover, the FDA also has approved a supplement to AEMD’s IDE for the Hemopurifier in viral disease to permit the testing of the device in patients with SARS-CoV-2/COVID-19 in a new feasibility study. AEMD intends to enroll up to 40 COVID-19 ICU patients at up to 20 domestic centers. Endpoints will include safety, reduction in circulating virus and clinical outcomes.
We are encouraged by the company’s pipeline to study the Hemopurifier in two early feasibility studies around the treatment of patients with head and neck cancer and, separately, those with COVID-19.
In August 2020, the National Institute for Dental and Craniofacial Research (NIDCR) awarded a grant to Aethlon and the University of Pittsburgh for collaborative multi-institution studies in head and neck cancer. The grant, valued at up to $3.5 million over five years, will profile the biomarkers of exosomes in patients with recurrent and metastatic head and neck cancer and study the impact of clinical depletion of exosomes using the Hemopurifier. We also believe this, and other recent grants and/or awards, validates the potential of the Hemopurifier.
The company is well-capitalized, with $15.7 million in cash, up from $9.6 million at the end of fiscal 2020 (AEMD’s fiscal year ends March) and no debt as of June 2020. The company has also been adept at leveraging non-dilutive funding to supplement its R&D spending.
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