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Aethlon Medical Announces Data Against Metastatic Melanoma

PRNewswire

SAN DIEGO, Sept. 9, 2010 -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that its researchers have demonstrated the ability of the Aethlon Hemopurifier® to capture immunosuppressive exosomes derived from individuals with metastatic melanoma.

(Photo:  http://photos.prnewswire.com/prnh/20090325/LA88762LOGO-b)

The Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. Metastatic melanoma is an advanced stage of skin cancer where cancer cells have spread to tissues, lymph nodes, or body organs.  The classification of either stage III or IV denotes metastasis. Metastasis greatly affects the survival rate or life expectancy of patients with melanoma.  The 5-year survival rate of stage III melanoma is approximately 50% to 68%, while stage IV survival is approximately 18%.

"Our goal is to provide oncologists with a device that will improve effectiveness of melanoma cancer therapies without adding drug toxicity or interaction risks," stated Aethlon Chairman and CEO, Jim Joyce.  "The data also provides supporting insight that our Hemopurifier® has broad-spectrum activity against various forms of cancer." Aethlon previously demonstrated that the Hemopurifier® was effective in capturing exosomes from the fluids of five ovarian cancer patients during in vitro studies.

Aethlon believes the Hemopurifier® represents the sole therapeutic strategy to directly inhibit or reverse the deleterious effects associated with exosomes secreted by tumors as a survival mechanism for cancer. Tumor-secreted exosomes have been reported to trigger programmed cell death (apoptosis) of immune cells; interrupt T-cell signaling required to mount an immune response; inhibit the production of anti-cancer cytokines, and have implications in the spread of metastasis and allowing for angiogenesis.

In the study, small-scale versions of the Hemopurifier® removed 73% of melanoma derived exosomes from cell culture fluids in one hour and 87% in two hours. The study also documented the capability of a diagnostic device being advanced by Aethlon Medical's wholly owned subsidiary Exosome Sciences, Inc.  The device, known as an enzyme linked lectin specific assay (ELLSA) was proven to directly detect melanoma derived exosomes from fluid samples. Previously, exosomes had been measured by total protein content in purified samples and by indirect immunomodulatory effects.  ELLSA directly measures exosome particles in complex solutions, and has already been found capable of detecting exosomes from other sources, including ovarian cancer and tuberculosis-infected macrophages.  While the Hemopurifier® represents a new therapeutic strategy to address cancer, ELLSA is being advanced to provide the ability to diagnose and monitor cancer progression.  

About Aethlon Medical

At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.

Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.

Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs.  However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union.  In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.

As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:

  1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
  2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.  
  3. Human Immunodeficiency Virus (HIV):  Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
  4. Bioterror and Pandemic Threats:  Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.

 

The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.

In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.

Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.

Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.  Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.

SOURCE Aethlon Medical, Inc.

For further information: John P. Salvador, Director Communications & Investor Relations, (858) 459-7800 ext. 307, jps@aethlonmedical.com


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