SAN DIEGO, Sept. 12, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB: AEMD), today announced the formal launch of Exosome Sciences, Inc. (ESI), a wholly-owned subsidiary previously established by Aethlon to pursue exosome-based strategies to diagnose and monitor the progression of cancer, infectious disease and other life-threatening conditions. Exosomes produced by diseased cells represent an optimal diagnostic target as they are shed into bodily fluids such as urine and blood where they can be easily accessed. Exosomes transport specific disease-origin markers that provide the basis for ESI to establish non-invasive liquid biopsies to diagnose and monitor a wide-range of disease conditions.
Aethlon Chairman and CEO, Jim Joyce stated, "As a therapeutic organization, our primary focus is the clinical advancement and future commercialization of the Aethlon Hemopurifer® in the United States and abroad. With this mind, our objective with ESI is to transform a currently dormant and unvalued diagnostic asset into a stand-alone organization that contributes measurable asset value to Aethlon shareholders, yet does not dilute our team's focus away from advancing first-in-class therapeutic devices. It also became clear that the launch of ESI might allow us to leverage recent valuations that have been awarded to molecular diagnostic organizations with novel technology strategies."
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 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 Company may not be able to secure financing for ESI as a freestanding entity, that ESI will not be able to develop commercially successful products, the FDA will not approve the initiation of the Company's future clinical programs or provide market clearance of the Company's products, future human studies whether revenue or non-revenue generating from either compassionate use or non-compassionate use 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 sepsis therapies or as a standalone cancer or hepatitis C therapy or standalone sepsis therapy, the approval of the Company's technologies or products as a treatment against pandemic threats, 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.