Aethlon Medical and Exosome Sciences Announce the Advancement of a Broad-Spectrum Cancer Detection and Monitoring Platform
SAN DIEGO and PRINCETON, N.J., Sept. 8, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), and its diagnostic subsidiary, Exosome Sciences, Inc. (ESI), announced today that ESI researchers have developed and initially validated a lectin-based diagnostic platform that is able to isolate exosome-based biomarkers underlying a broad-spectrum of oncology indications. Aethlon Medical develops targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions. ESI develops exosome-based solutions to diagnose and monitor cancer and neurodegenerative disorders.
In the validation studies, ESI researchers provided evidence that their diagnostic platform could identify the presence of cancer in analyzed blood samples from individuals suffering from glioblastoma, metastatic melanoma, breast cancer, ovarian cancer, colorectal cancer and pancreatic cancer. Beyond the potential implications in diagnosing cancer, ESI researchers believe the high-sensitivity of the platform will allow for effective monitoring of cancer progression and response to corresponding therapies. In oncology indications, the sensitivity of the ESI platform also represents an advancement over the ELLSA assay that was originally developed by Aethlon Medical to quantify changes in circulating exosome load resulting from the administration of Aethlon Hemopurifier® therapy. The Hemopurifier® is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes, which in addition to being an oncology biomarker, suppress the immune system and contribute to the spread of metastasis in cancer patients.
Based on previously reported discoveries related to progressive neurodegenerative disorders, Aethlon further disclosed that the ESI team has initiated follow-on studies to advance a candidate blood test to identify and monitor the progression of Chronic Traumatic Encephalopathy (CTE). At present, CTE is only diagnosed through postmortem autopsy. CTE has been most commonly found at autopsy in former National Football League (NFL) players and has also been demonstrated to be prevalent in soldiers exposed to blast injury.
In previous disclosures, ESI researchers reported that they had successfully isolated brain-specific biomarkers that could have implications in the diagnosis, monitoring and treatment of Alzheimer's Disease (AD), CTE and Glioblastoma Multiforme (GBM). The studies provided evidence that the ESI platform could also detect exosomes as a basis for a "liquid biopsy" to diagnose neurologic conditions. While exosomes from the central nervous system had previously been identified in the cerebrospinal fluid, the ESI team identified exosomes carrying brain-specific markers tau, beta-amyloid, glycoprotein A2B5 and S100B protein that had been transported across the blood-brain barrier and into the circulatory system.
"I am immensely proud of the ESI research team as their considerable breadth of collected data reinforces the possibility that a single platform could detect and monitor a wide-range of disease conditions," stated Aethlon Medical CEO Jim Joyce, who also serves as Executive Chairman at ESI. Mr. Joyce founded ESI on behalf of Aethlon Medical shareholders as a means to explore if the lectin-affinity techniques underlying Hemopurifier® therapy could provide a basis for proprietary diagnostic applications.
In the oncology platform validation studies, 198 single point serum specimens (taken at the time of cancer diagnosis) were analyzed from patients with Glioblastoma, Metastatic Melanoma, Breast cancer, Ovarian cancer, Colorectal cancer and Pancreatic cancer, plus 20 age-matched, female and male non-cancer controls. In the studies, the ESI platform was consistently able to differentiate individuals afflicted with cancer as compared to non-cancer controls. The tested serum specimens were obtained from commercial and collaborative academic biorepositories. A breakdown of the analyzed cancer specimens include:
– Glioblastoma – 5 late stage
– Metastatic Melanoma – 20 late stage
– Ovarian cancer - 31 early stage and 114 late stage
– Colorectal cancer – 7 early stage and 7 late stage
– Pancreatic cancer – 2 early stage and 12 late stage
Based on the data collected, ESI plans to establish collaborations and clinical partnerships to further validate its platform and identify specific oncology and neurodegenerative indications where the platform offers to improve upon standard of care methods to diagnose and monitor disease progression.
Additional study details will be presented at the Exosomes & Single Cell Analysis Summit to be held on September 18th and 19th, 2014.
About Exosome Sciences, Inc.
Exosome Sciences (ESI), a majority wholly owned subsidiary of Aethlon Medical, Inc., develops exosome-based solutions to improve identification and monitoring of acute and chronic conditions. Our candidate products are focused toward diagnostic advancements in the fields of oncology, infectious disease and brain injury. Exosomes represent an optimal diagnostic target as diseased or injured cells release these particles into body fluids such as urine, blood, saliva and cerebrospinal fluid where they can be accessed for analysis. Our exosome-based assays unlock the ability to identify proteomic and genomic alterations underlying a wide-range of pathologies, thus allowing for the introduction of novel non-invasive "liquid biopsies". Additional information can be found at www.ExosomeSciences.com.
About Aethlon Medical, Inc.
Aethlon Medical creates medical devices that target unmet therapeutic needs in infectious disease and cancer. The company's lead product is the Aethlon Hemopurifier®, a first-in-class device that selectively targets the rapid elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression. Exosome Sciences, Inc. is a majority owned subsidiary that is advancing exosome-based products to diagnose and monitor cancer, infectious disease and neurological disorders. Additional information can be found online at 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 ESI will not be able to commercialize its future products, 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 or as a broad spectrum defense against viral pathogens, 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, the ability of the Company to meet the milestones contemplated in the DARPA contract, 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
SOURCE Aethlon Medical, Inc.
Released September 8, 2014