Aethlon Medical plans to initiate patient recruitment for cancer immunotherapy study

May 4 2010

Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that it plans 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 first-in-class medical device to selectively remove infectious viruses and immunosuppressive proteins from the circulatory system.  

"The FDA's landmark approval of Provenge from Dendreon Corp last week has opened the door for immunotherapeutic strategies to address cancer," stated Aethlon Chairman and CEO, Jim Joyce.  "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," stated Joyce.

On April 29th, Provenge became the first immunotherapy approved in the United States. The drug, which targets to enhance patient immune response will be marketed as a treatment for men with advanced prostate cancer that have grown resistant to standard hormone therapy. Cancer treatments that improve the ability of the immune system to attack cancer have been a hope for decades, as the strategy promises for fewer side effects than chemotherapy and invasive procedures. Analysts believe the approval of Provenge will usher in the establishment of a cancer immunotherapy industry.

Researchers 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. These particles, known as exosomes, are released by solid tumors, lymphomas, and leukemia. High concentrations of circulating exosomes correlate with reduced T-cell production and tumor progression in 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 United States and the European Union. Aethlon 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 D. Taylor, Ph.D., Professor of Obstetrics, Gynecology, and Women's Health at the University of Louisville, has been initiated to determine the capability of the Hemopurifier® to capture immunosuppressive exosomes associated with breast cancer. Dr. Taylor previously conducted studies that validated the Hemopurifier® was effective in capturing immunosuppressive exosomes associated with ovarian cancer. An in vitro study, under the collaboration of Andrew Raubitschek, M.D., Chair of the Department of Cancer Immunotherapeutics & Tumor Immunology at the Beckman Research Institute of City of Hope in California, has been initiated to determine the capability of the Hemopurifier® to capture lymphoma related exosomes. Dr. Raubitschek is also Co-leader for the Cancer Immunotherapeutics Program at the Comprehensive Cancer Center and Chief of Radioimmunotherapy and Professor, Radiation Oncology also at the City of Hope.

SOURCE Aethlon Medical, Inc.