SAN DIEGO, June 2, 2011/PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD) today announced that Company President Rodney S. Kenley will discuss the role of the Aethlon Hemopurifier® in the treatment of hepatitis C virus (HCV) in an upcoming presentation at the 20th International Vicenza Course of Hemodialysis and CKD (chronic kidney disease) on Wednesday, June 8, 2011 in Vicenza, Italy. The Aethlon Hemopurifier® is a first-in-class therapeutic filtration device that selectively removes infectious viruses and immunosuppressive toxins from the entire circulatory system through the use of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
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Mr. Kenley’s presentation, “The Treatment of HCV with Affinity Plasmapheresis on Dialysis Machines,” will focus on treating HCV in existing dialysis clinics with no change in infrastructure or capital investments. The Hemopurifier® can be used to treat HCV in dialysis patients, in whom the prevalence of HCV is over 100 times higher than in the general population, as well as to treat non-dialysis patients.
“I am particularly honored to be asked to participate in this preeminent annual dialysis conference considering that my subject matter is a bit of a departure from the usual content of this meeting,” said Mr. Kenley. “I believe that this is an indication of the gravity and prevalence of hepatitis C infections in the end-stage renal disease population and the interest the clinicians in this field have in learning about new approaches to this disease. Given Aethlon’s intent to perform future clinical trials in Europe aimed at an eventual European regulatory approval, the opportunity to expose clinicians from all across Europe to our technology could prove to be very helpful when it comes time to recruit clinical investigators.”
Human studies have documented the ability of the Hemopurifier® to safely reduce viral load in both HCV and human immunodeficiency virus (HIV) infected patients without the administration of antiviral drugs. The Company’s clinical and early commercialization focus includes advancing the Hemopurifier® as an adjunct therapy to enhance the benefit of infectious disease and cancer treatment regimens. The Company’s plan is to commercialize the Hemopurifier® in India as it advances clinical strategies in the United States and the European Union. Aethlon is currently conducting a clinical study at the recently opened, $360-million Medanta Medicity Institute near Delhi, India. A clinical goal of the study is to demonstrate that the Hemopurifier® accelerates early viral load reduction when combined with HCV standard of care drug regimens.
The 20th International Vicenza Course of Hemodialysis and CKD Course is organized in collaboration with the International Society of Nephrology and the Commission for the Global Advancement of Nephrology (COMGAN), in conjunction with the International Society of Hemodialysis. The Vicenza Course on hemodialysis is made in strict collaboration with the industry of the field.
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.
We recently introduced the Aethlon ADAPT system, an adaptive dialysis-like affinity platform technology. Our platform technology allows marketed drugs, clinical-stage drugs and agents that previously failed clinical studies to be repurposed within a therapeutic filtration design that results in an expedited and less costly medical device pathway.
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 therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes 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.
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:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- 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.
- 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 ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT system, the FDA’s willingness to meet with company officials to discuss re-initiation of an Investigational Device Exemption (IDE) study, or the FDA’s willingness to meet with company officials to discuss Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats, the Company’s ability to conduct clinical trials in Europe or to achieve regulatory approval in Europe, the Company’s ability to commercialize its Hemopurifier® in India, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such ascancer or Hepatitis-C, 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.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
SOURCE Aethlon Medical, Inc.
