Aethlon Medical, a provider in developing therapeutic filtration devices to address infectious disease and cancer, is planning to initiate patient recruitment for a cancer immunotherapy study by year end.
The pilot study seeks to demonstrate an improved immune function in cancer patients as a result of the Aethlon Hemopurifier removing tumor-secreted exosomes from the circulatory system.
Exosomes induce T-cell apoptosis (programmed cell death), and block T-cell signaling, proliferation, and cytokine production in cancer patients. The Hemopurifier is the medical device to selectively remove infectious viruses and immunosuppressive proteins from the circulatory system.
Aethlon said that the researchers had recently discovered that the Aethlon Hemopurifier, which is being advanced to market as an adjunct therapy to improve Hepatitis-C virus (HCV) treatment outcomes, is effective in capturing particles that suppress the immune system of cancer patients.
The ability to preserve immune cells by inhibiting the immunosuppressive activity of exosomes is an unmet medical need that would likely improve patient responsiveness to chemotherapy and other cancer treatment strategies. Like other human studies initiated by Aethlon, the pilot study will be conducted in India, which provides both a proof-of-concept and early commercialization pathway.
Treatment data points that verify improved immune function in Hemopurifier treated patients will be the basis for Aethlon to pursue clinical programs in the US and the European Union.
Aethlon Medical will disclose the site of the pilot study along with treatment protocols in the coming months. In the interim, Aethlon has initiated in vitro research studies aimed at determining the capability of the Hemopurifier to capture immunosuppressive exosomes associated with breast cancer and lymphoma.
An in vitro study, under the collaboration of Douglas Taylor, professor of Obstetrics, Gynecology, and Women’s Health at the University of Louisville, has validated that the Hemopurifier was effective in capturing immunosuppressive exosomes associated with ovarian cancer.
Jim Joyce, chairman and CEO of Aethlon, said: “The FDA’s landmark approval of Provenge from Dendreon Corp last week has opened the door for immunotherapeutic strategies to address cancer. In this regard, we are going to expand our clinical programs beyond infectious disease as we believe our Hemopurifier is the sole treatment strategy to directly inhibit exosomes from destroying immune cells needed to combat cancer.”