We Have Met the Enemy and He is Us* — But Not If Aethlon Medical Has Its Way!

Why can’t the human body immune system prevent all cancers? Because the immune system generally does not identify ordinary human cells — an essential building block of the human body — as a threat to the body, notwithstanding that such cells may possess an uncontrolled level of proliferation. To the extent that the immune system recognizes that certain cancer cells are “suspicious,” solid cancer tumors (including ovarian) further inhibit the attack capability of the immune system by secreting so-called “exosomes.”

Normally, immune system cells known as “T-cells” are entrusted with killing foreign invaders that may be harmful to the body. Exosomes secreted by ovarian cancer cells prevent the “expression” or activation of two biological markers (i.e., Jak-3 kinase & CD3-zeta) which must be present as a prerequisite for T-cell activation. Generally, the biological markers Jak-3 kinase and CD3-zeta are highly expressed in activated T-cell lines. When T-cells are subjected to ovarian cancer ascites fluid, the critical Jak-3 kinase and CD3-zeta biological markers are consistently absent. In sum, the exosomes secreted by ovarian cancer cells produce immunosuppressive activity within the human body and allow the cancer cells to avoid destruction by causing T-cell inactivation. The immunosuppressive activity associated with ovarian cancer is known to correlate with disease progression and reduced long-term survival.

Aethlon Medical, Inc., a pioneer in developing medical devices to treat infectious disease, developed a device known as the “Hemopurifier®” which is capable of removing immunosuppressive exosomes from ovarian cancer cell fluid, thereby allowing proper activation of immune system T-cells that are capable of killing cancer cells. In follow-on studies, Dr. Douglas Taylor at the University of Louisville demonstrated that the capture of exosomes by the Hemopurifier(R) resulted in reversing immunosuppressive activity (i.e., eliminate exosomes). Throughout the course of the studies, the Aethlon Hemopurifier® completely removed the immunosuppressive activity normally found in the ascites fluid of ovarian cancer patients.

Prior to conducting the follow-on studies mentioned above, Dr. Taylor documented that 60% of circulating exosomes were removed from the blood of ovarian cancer patients during the first pass (approximately 10-minutes) through a small scale Hemopurifier®. The capture data was consistent over the course of five different studies. Exosomes are released by solid tumors, lymphomas, and leukemia. Because exosomes induce T-cell apoptosis (programmed cell death), and block T-cell signaling, proliferation, and cytokine production, high concentrations of circulating exosomes correlate with reduced T-cell production and tumor progression in cancer patients. The ability to reduce the presence of circulating exosomes could reverse immune suppression and increase patient responsiveness to both immunotherapy and chemotherapy. As such, Aethlon believes that the Hemopurifier(R) addresses a significant unmet medical need in cancer care.

Dr. Taylor is a recognized authority on the causative effects of immune suppression in cancer patients. He is credited with the initial characterization of exosomes and is a leading peer reviewed author on the subject. Aethlon disclosed that Dr. Taylor did not receive nor request any compensation for conducting the research studies mentioned above.

“Based on emerging data, we envision the Hemopurifier(R) will become a treatment standard that enhances the benefit of therapies administered to those who suffer from cancer,” stated James A. Joyce, Chairman and CEO of Aethlon Medical.

Aethlon Medical Company Background

“Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device to treat infectious disease. The Hemopurifier® addresses the largest opportunity in infectious disease, the treatment of drug and vaccine resistant viruses. The Hemopurifier(R) is a single use extracorporeal device that converges hollow-fiber filtration technology with immobilized affinity agents to capture viruses and soluble glycoproteins from the blood. The device has been designed to mimic the natural immune response of clearing infectious viruses and immunosuppressive proteins from circulation. Regulatory and commercialization initiatives in the United States are focused on bioterror threats, while international initiatives are directed towards naturally evolving pandemic threats, and chronic infectious disease conditions including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Collaborative studies to demonstrate utility of the Hemopurifier(R) are being conducted with researchers at the Government of India’s National Institute of Virology (NIV), The U.S. Centers for Disease Control and Prevention (CDC), The United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and The Southwest Foundation for Biomedical Research (SFBR). Aethlon recently demonstrated safety of the Hemopurifier(R) in a 24-treatment human study and is now conducting follow-on safety studies at the Fortis Hospital in Delhi, India. The Company has also submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) related to advancing the Hemopurifier(R) as a broad-spectrum treatment countermeasure against category “A” bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier(R) technology can be accessed online at www.aethlonmedical.com.”

[Post Source and Quoted Post Source: “The Aethlon Hemopurifier(R) Reverses Immune Suppression in Cancer,” Aethlon Medical, Inc. News Release dated November 19, 2007].

*[Post Title Source: The “foreword” chapter of The Pogo Papers, written by Walt Kelly and published by Simon & Schuster (Paper) (June 1953). The complete Kelly foreword chapter quote (which is a paraphrase of a message sent in 1813 from U.S. Navy Commodore Oliver Hazard Perry to Army General William Henry Harrison after The Battle of Lake Erie stating “We have met the enemy, and they are ours”) is “There is no need to sally forth, for it remains true that those things which make us human are, curiously enough, always close at hand. Resolve then, that on this very ground, with small flags waving and tinny blast on tiny trumpets, we shall meet the enemy, and not only may he be ours, he may be us.” Walt Kelly first used the abbreviated quote “We Have Met The Enemy and He Is Us” on a poster for Earth Day in 1970.]

CNN Reports On the Hemopurifier®

Five Years Later, Patient Participating in Vaccine Trial Remains Free of Ovarian Cancer

“Like most women with ovarian cancer, 44-year-old Christine Sable of Lancaster, Pennsylvania, did not discover she had the disease until it was in the advanced stages and had spread to other areas of the abdomen. ‘I knew my chances of recurrence were very high-75 to 80 percent at that particular stage-and that the disease would likely recur within a year or two,’she says. ‘Once it recurs, it is difficult to cure.’

After aggressive surgery and chemotherapy, the only other option her doctor could offer was more chemotherapy. But the first round had been ‘very hard,’ Sable recalls. ‘I wanted to find something that would work with my own immune system and not be so harsh on my body.’

Then she learned about a Phase I clinical research study of an ovarian cancer vaccine developed by Kunle Odunsi, MD, PhD, Surgeon in Gynecologic Oncology and Co-Leader of the Tumor Immunology and Immunotherapy Program at Roswell Park [Cancer Institute]. The vaccine is designed to trigger an immune response in the significant number of women who have tumors that test positive for the antigen NY-ESO-1.

The study was open to patients who had completed their initial treatments and who had no further evidence of disease; Sable fit the profile. She says the day she was accepted into the study was ‘one of the most exciting days of my life.’ She began treatment at Roswell Park in February 2004, and her immune system responded so strongly to the first five doses of vaccine that she received another five, then another five, each time experiencing a better response-with no side effects. Now 49 and still cancer-free, she returns to Roswell Park just once a year for continued monitoring.

Odunsi is currently leading a team of Roswell Park researchers who are working to improve the vaccine’s effectiveness. The vaccine is an important new focus in the search for better treatments for ovarian cancer, which is often difficult to treat. Sable says participating in the trial ‘was a very good experience; I was very well cared for. Dr. Odunsi is a gentle, kind man, brilliant and dedicated and very compassionate.’ In May of 2008, Sable will mark the fifth anniversary of her diagnosis and survival. ‘To have had this many years cancer-free is really amazing.’

The study in which she participated was supported by the Cancer Vaccine Collaborative Program of the Cancer Research Institute and Ludwig Institute for Cancer Research, and results were reported in the … [NY-ESO-1 Peptide Vaccine Phase I Clinical Trial Results, Odunsi, K et. al., Proceedings of the National Academy of Sciences, Vol. 141, no 31, July 31, 2007].” [Quoted Source: Science Daily News Release dated April 7, 2008.]

In March 2008, The Ovarian Cancer Research Fund (OCRF) awarded a $900,000 research grant to Dr. Odunsi and his colleagues at the Roswell Park Cancer Institute (RPCI) to fund a collaborative study with the stated goal of developing a promising vaccine to unleash the power of the immune system against cancer. The prestigious award will allow Dr. Odunsi and the RPCI research team to combine four different immunotherapy approaches, all designed to enhance the immune system’s response to ovarian cancer. [Source: “Roswell Park Cancer Institute awarded three-years funding for ovarian cancer vaccine,” a News-Medical.Net News Release dated April 7, 2008.]

Comment: Vaccine or immunotherapy can play an important role in an ovarian cancer survivor’s overarching treatment strategy. This aspect of treatment is often overlooked. It is important to be aware of the availability of vaccine therapy as early as possible in treatment because most clinical trials utilizing vaccine therapy require an extremely low disease “tumor burden” or no (macroscopic) evidence of disease as a prerequisite for patient eligibility. Low tumor burden or no evidence of disease is generally present immediately after chemotherapy treatment(s) resulting in “complete remission,” and/or surgery resulting in “optimal debulking/cytoreduction.” Christine Sable is an excellent example of an ovarian cancer survivor who is proactively managing her care through enrollment in a beneficial clinical trial.

The Roswell Park Cancer Institute, as of this writing, is currently recruiting Stage II through IV ovarian cancer participants for a Phase II vaccine clinical trial involving the use of “Recombinant Vaccinia-NY-ESO-1 (rF-NY-ESO-1) and Recombinant Fowlpox-NY-ESO-1 (rF-NY-ESO-1) in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen.” For more information with respect to this clinical trial, contact the Roswell Park Cancer Institute Clinical Trials Office at 877-275-7724.

I encourage you to watch the video segment below which addresses Christine Sable’s case, including an interview with Kunle Odunsi, M.D., Ph.D.., the Co-Leader of the Tumor Immunology and Immunotherapy Program at Roswell Park.

MediaSourceTV Video Segment Re

Christine Sable and Roswell Park Cancer Institute Clinical Trial Vaccine Program