SAN DIEGO, May 19, 2011 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD) announces the introduction of the Aethlon ADAPT™ system, an adaptive dialysis-like affinity platform technology that provides a novel and potentially expedited commercialization pathway for monoclonal antibodies and other affinity drug agents. The platform technology allows for single or multiple biologic agents to be immobilized within a therapeutic filtration design that results in a significantly less burdensome medical device regulatory approval pathway compared with the pathway for drugs or biologics.
The Company will market the Aethlon ADAPT™ system to drug developers as the basis for new therapeutic devices that target high-risk disease conditions. The Aethlon ADAPT™ system allows for the selective removal of disease-related particles from the entire circulatory system without the loss of essential blood components. It eliminates the need to infuse drug agents into the body as blood filtration occurs outside of the body. As a result, new devices evolved from this platform will not add drug toxicity or drug-drug interaction risks if combined with other therapies. The Aethlon ADAPT™ system also provides the potential to immobilize greater quantities of therapeutic drug agents compared with amounts that can be safely administered systemically. The platform may also be utilized to immobilize a cocktail of drug agents within a single device to address multiple factors underlying a single disease condition.
"The Aethlon ADAPT™ system provides the drug industry a new regulatory and commercialization pathway for their monoclonal antibodies and affinity drug agents," stated Aethlon CEO Jim Joyce. "The timing for introducing our platform could not be better considering the scope of increasing and unpredictable regulatory challenges faced by therapeutic drug developers."
The genesis of the Aethlon ADAPT™ system is the Aethlon Hemopurifier®, a broad-spectrum antiviral device that immobilizes a single lectin-affinity agent to bind circulating viruses, immunosuppressive proteins and disease-enhancing exosomes associated with both infectious diseases and cancer. Human studies of the Hemopurifier® have demonstrated average viral-load reductions exceeding 50% during four-hour treatment periods in individuals infected with hepatitis C virus (HCV) and HIV, without the administration of antiviral drugs. A human study is now underway to test the ability of the Aethlon Hemopurifier® to improve clinical outcomes in patients receiving HCV drug therapy.
On April 1, 2011 the Company leveraged the principles of the Aethlon ADAPT™ system to propose a new device that would reduce the incidence of sepsis in wounded military personnel through a contract response to a dialysis-like therapeutics program offered by the Defense Advanced Research Projects Agency (DARPA). Aethlon is currently preparing a submission to another government agency that would propose the use of the Aethlon ADAPT™ system to create a third company-owned therapeutic device.
Since the beginning of 2011, Aethlon Medical has expanded its channels for early revenue generation beyond the candidate use of its Hemopurifier® in HCV care. In addition to potential development revenues from new devices created from the Aethlon ADAPT™ system, the Company has positioned itself to be a candidate recipient of contract and grant income from government agency solicitations, and is considering the launch of a research diagnostic tool line developed by its wholly owned subsidiary Exosome Sciences, Inc.
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 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.
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:
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 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.