SAN DIEGO, Sept. 21 /PRNewswire/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, disclosed today that it has reestablished efforts to advance the Aethlon Hemopurifier® within U.S. Government programs that support the development and purchase of treatment countermeasures against bioterror threats. The Aethlon Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. Based on studies conducted by government and non-government research organizations, Aethlon believes the Hemopurifier® represents the most advanced and perhaps the only true broad-spectrum countermeasure against viral threats most likely to be weaponized against civilian and military populations.
Therapeutics able to target multiple bioterror threats have become a focal point of the U.S. Health and Human Services Department (HHS) and dual-use therapies such as the Hemopurifier®, that also have commercial applications against established disease conditions such as hepatitis-C virus (HCV) and cancer, are no longer precluded from consideration to be supported by government programs.
"Revamped government policies expand the opportunity for our Hemopurifier® in the United States and improve our potential access to non-dilutive capital resources, which are not capped by the public market value of our organization," stated Aethlon Chairman and CEO, Jim Joyce. "We now plan to update an investigational device exemption (IDE) already submitted to the FDA, which if approved, would allow us to collect further clinical data that potentially could contribute to other infectious disease and cancer studies we hope to initiate in the United States."
The IDE previously submitted to the FDA by Aethlon specifies the Hemopurifier® as a medical device for the single-use removal of bioterror related viruses from circulation. As efficacy studies against such pathogens cannot be conducted in humans, the demonstration of treatment safety represents the primary treatment challenge in humans. While efficacy studies against such threats may not be permissible, Aethlon has demonstrated significant viral load reductions in HIV and HCV infected individuals. In vitro studies have verified that the Hemopurifier® has broad-spectrum capabilities against both bioterror and emerging pandemic threats. These studies confirmed the ability of the Hemopurifier® to capture 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.
The landscape to encourage countermeasure development is rapidly improving. Last month, the Obama administration announced it would seek to improve government efforts to spur development of countermeasures for potential biological-weapon agents and HHS declared that programs intended to prepare the country for biological weapons attacks would be overhauled with a focus toward decreasing the length of time it takes to produce new medical countermeasures, and that new institutes would be established to collaborate with small firms on the production of new treatments. Additionally, funding will be directed to the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to turn scientific breakthroughs into medical countermeasures. From a regulatory perspective, the FDA has indicated that it will take steps to eliminate obstacles that could slow the pace of the countermeasure review process.
About Aethlon MedicalAt 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:
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 company's access to funding through U.S. Government programs supporting the development and purchase of treatment countermeasures against bioterror threats, 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.Contacts:James A. JoyceChairman, CEO858.459.7800 firstname.lastname@example.orgJohn P. SalvadorDirector, Communications & Investor Relations858.459.7800 email@example.comJon CunninghamRedChip Companies, Inc.800.733.2447 firstname.lastname@example.org
|SOURCE Aethlon Medical, Inc.|
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