Aethlon disclosed that ESI's research facility is being established within a CLIA certified laboratory located in Langhorne, Pennsylvania. The facility is adjacent to the Philadelphia/New Jersey I-95 corridor, which is the home for numerous U.S. biopharmaceutical organizations, including Merck and Johnson & Johnson. The introduction of key ESI researchers who will lead the development and commercialization of next-generation diagnostics will occur through follow-on disclosures.
At present, Aethlon is preparing to launch the first U.S. studies of the Hemopurifier® as a therapy to address hepatitis c virus (HCV) based on the recent approval of an Investigational Device Exemption (IDE) by the United States Food and Drug Administration (FDA). The Hemopurifier is a first-in-class device that targets the rapid elimination of infectious disease and cancer glycopathogens, including exosomes from circulation. Exosomes enhance disease progression of viral infections and in cancer trigger apoptosis of immune cells and have been reported to facilitate tumor growth, metastasis, and the development of drug resistance.
Aethlon will contribute diagnostic related technology to ESI, including the Enzyme Linked Lectin Specific Assay (ELLSA), which has been validated to identify the presence of exosomes underlying the human immunodeficiency virus (HIV), tuberculosis (TB), and various forms of cancer, including ovarian, melanoma, breast, lymphoma, and colorectal. ELLSA was originally created by Aethlon researchers as a tool to help validate the ability of the Hemopurifier® to capture tumor-secreted exosomes. At the time, effective tools to isolate and quantify exosomes did not exist as few labs conducted exosome research. Since then, an increased understanding of the role of exosomes underlying a wide-range of disease conditions has created a demand for related diagnostic products. As part of the relationship, ESI has agreed to assign any therapeutic related discoveries back to Aethlon Medical. Beyond the potential for future technology advances by ESI researchers, ESI may also in-license related diagnostic IP from collaborative research partners.
The release of exosomes by viable cells has been demonstrated in multiple cell types and systems. These nano-sized vesicles are detectable in biologic fluids, including blood, urine, ascites, and pleural fluids. They are essential mediators of normal homeostasis, based on their role in intercellular communication via surface interactions and transfer of macromolecules between cells. Cell injury or transformation is associated with alterations in the cell's exosome production and composition of these exosomes. This aberrant exosome composition can be utilized as surrogate markers of specific disease pathologies. The ESI mission is to advance an exosome-based biomarker platform to diagnose a broad-spectrum of disease conditions as well as monitor disease progression/regression in response to therapy as a means to improve patient management and outcomes. In the oncology field, ESI products will also be positioned to serve as companion diagnostics that determine when to initiate Hemopurifier® therapy or provide real-time monitoring of tumor responses to Hemopurifier® therapy.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
Certain 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, that the company can successfully protect its intellectual property, that removal of exosomes from the human body will impact or lead to successful treatment of cancer, or that exosomes are the cause of tumor growth and progression, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned 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. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
James A. Joyce
Chairman and CEO
Chief Financial Officer
Published at Investorideas.com newswire
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