Aethlon Medical Inc, a therapeutic medical device and technology company focused on unmet needs in global health, announced that it has received European Patent No. 1,993,600 (the '600 Patent) entitled "Extracorporeal Removal of Microvesicular Particles." The '600 patent embodies Aethlon's Hemopurifier technology designed for the depletion of immune suppressive, and potentially cancer-promoting, exosomes from the circulatory system.
Exosomes have been shown to participate in the development and advancement of cancer. Exosomes derived from tumor cells may promote immune suppression and seed the spread of metastasis. Notably, these tumor derived exosomes may also inhibit the activity of immuno-oncology drugs such as pembrolizumab (Keytruda). Tumor derived exosomes are not currently addressed with an approved therapy.
Aethlon has demonstrated the ability of laboratory versions of the Hemopurifier to capture exosomes underlying several forms of cancer, including breast, ovarian and melanoma, in laboratory experiments. In November 2018, Aethlon received a "Breakthrough Device" designation from the US Food and Drug Administration (FDA) to support the advancement of the Hemopurifier for the treatment of cancer. In October 2019, the US FDA approved Aethlon's Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the Hemopurifier in patients with advanced head and neck cancer in combination with standard of care Keytruda. These EFS, which is the device equivalent of a phase 1 trial, will be a small single center, open label trial in 10 to 12 subjects.
"By reducing the presence of tumor-derived exosomes from the circulatory system of cancer patients, we believe the Aethlon Hemopurifier could have the potential to improve the benefits of existing cancer treatment regimens and emerging immuno-oncology drugs," stated Timothy C. Rodell, M.D., Aethlon's CEO. "This issued European patent, along with corresponding issued patents in the United States and Canada, are critical for Aethlon's plans to develop the Hemopurifier for applications in oncology around the world."
In preclinical studies in cancer, the Hemopurifier depletes the presence of circulating tumor-derived exosomes that are believed to promote immune suppression. These tumor derived exosomes also appear to seed the spread of metastases and therefore may inhibit the benefit of leading cancer therapies.
The Hemopurifier is an US FDA designated "Breakthrough Device" related to the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease cancer. The Hemopurifier also holds a Breakthrough Device designation related to life-threatening viruses that are not addressed with approved therapies.
Aethlon also owns 80% of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disease progression.