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By M. Marin
Aethlon Medical, Inc. (NASDAQ:AEMD) reported 3Q FY2021 results last night and provided an updated outlook on the two clinical studies underway. The company is 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, is setting up internal infrastructure to support its growing opportunities.
One clinical study, of patients with head and neck cancer, is exploring the impact of clinical depletion of exosomes using the Aethlon Hemopurifier along with standard of care treatment, Keytruda. In August 2020, the National Institute for Dental and Craniofacial Research (NIDCR) awarded AEMD a grant for studies in head and neck cancer that will be a collaborative project between Aethlon and the UPMC Hillman Cancer Center at the University of Pittsburgh. The grant is valued at up to $3.5 million over five years for multi-institution studies.
The first patient in the cancer study was treated in December 2020, with no adverse safety consequences. The company is optimistic that enrollments will continue with little-to-no delay from the surge in COVID-19 cases. We would expect the company to release data from the study, following enrollment and treatment of all 10-12 participants, fairly shortly after the study is completed.
The revenue trajectory of Keytruda also shows the potential that a successful therapeutic treatment could have and that there are also other cancers that are exosome dependent that could benefit from the Hemopurifier. Keytruda generated $11.1 billion in revenue in 2019, up about 55% from $7.2 billion in 2018, and is Merck's most important product. Analysts are predicting that it could reach over $22 billion in revenue by 2025 and become the best-selling drug of all time.
COVID-19 could represent another opportunity and path to approval for the Hemopurifier, with the FDA having 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 another new feasibility study.
Management team has extensive healthcare experience
With several potential opportunities on the horizon, as illustrated in the company’s pipeline above, Aethlon has expanded its executive team in order to support the many opportunities the company has in front of it, hiring two key executives. The addition of these senior team members follows the October 2020 appointment of Charles J. Fisher, Jr., M.D. as AEMD’s CEO.
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