Aethlon Medical, Inc.,  a California-based public company creating innovative medical devices, 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 US 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 US 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.