SAN DIEGO, June 12, 2012 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
Last week, Medical News Today reported on a cancer research discovery that reinforces the potential importance of our therapeutic endeavors. For more than a century, cancer researchers have understood that certain forms of cancer only spread to specific, preferred organs. However, the mechanism underlying the spread of organ specific metastasis (the "soil and seed" theory of 1889) had remained unknown. Based on new findings published and now available online in the journal Nature, researchers have identified that circulating cancer-secreted particles known as "exosomes" play a significant role in fueling the metastatic invasion of preferred organs. The paper concludes that exosomes offer promise for new therapeutic directions in the metastatic process.
We applaud and appreciate this ground breaking research as our Hemopurifier® has been validated to capture the form of cancer-secreted exosomes referenced in the publication. The same Hemopurifier® that we have been advancing with promising results in the treatment of hepatitis c (HCV) infected individuals.
In the study, researchers were interested to see if exosomes budding from melanoma actually participated in the course of the cancer. The answer was yes, and to a great extent. The researchers identified that melanoma cancer cells released "exosome" vesicles (microscopic particles like "bubbles" that are filled with many different molecules such as proteins and nucleic acids) that travel to the bone, liver, lung and brain. This cellular material fuses with targeted organs and establishes the environment to spread tumor cells. The researchers also reported that cancer-secreted exosomes triggered inflammation, promoted leaky blood vessels and educated bone marrow progenitor cells to participate in the metastatic cascade. The discoveries were led by a team from the Weill Cornell Medical College, Memorial Sloan-Kettering Cancer Center, with collaborative support from researchers at MD Anderson Cancer Center, Lawrence Berkeley National Laboratory, the National Cancer Institute, and the US National Institutes of Health.
Dr. Hector Peinado, the lead author of the study was quoted to say: "If, in the future, we were able to find a way to control the education of bone marrow cells, as well as the release and content of tumor exosomes in cancer patients, we would be able to curtail and reduce the spread of cancer, and improve the patient's quality of life and survival." At present, I am not aware of another therapeutic strategy beyond our Hemopurifier® that offers to inhibit or eliminate the presence of cancer-secreted exosomes.
The Weill-Cornell researchers also identified that exosome protein levels in circulation predicted disease stage, prognosis, and survival in subjects with metastatic disease. When they compared circulating exosomes taken from patients with different stages of melanoma, they found that stage IV patients displayed much higher exosome protein levels as compared with earlier stage melanoma patients. If disease had not yet metastasized, exosomes were not present in circulation. The researchers also noted that stage IV patients with a lower presence of exosomes tended to have longer survival than stage IV patients with higher exosome protein content. Again, reinforcing the therapeutic potential of a device that could inhibit or eliminate exosomes from circulation.
Our first research into cancer-secreted exosomes was driven by the curiosity that exosomes seemed to carry a unique high mannose signature that is found on the surface of glycoproteins that coat infectious viral pathogens. This signature happened to be the targeted binding site of the affinity agent immobilized in our Hemopurifier®, and provides the basis for our ability to selectively capture HCV, HIV, and a broad-spectrum of other viruses. In well-studied viruses such as HIV, we knew that surface glycoproteins can shed to trigger apoptosis or programmed cell death of immune cells. Therefore, it made sense to us that exosomes might have these same immunosuppressive properties. However, at the time we initiated our research, the medical community consensus was that exosomes were nothing more than cellular trash bags with no meaningful biologic function. In fact, there were only a handful of researchers with exosome focused research programs. This is no longer the case. Many cancer research institutes are now pursuing exosome driven initiatives as cancer-secreted exosomes have since been verified to play a significant role in the invasion of the immune system in cancer patients. Additionally, researchers now understand how exosomes contribute to the development of tumor angiogenesis as a mechanism for cancer to survive. The harmful role of exosomes is also being identified in other life threatening conditions, including sepsis, a disease we are studying under contract with the Defense Advanced Research Projects Agency (DARPA).
To date, we have demonstrated the ability to capture exosomes underlying a variety of cancers. As related to the discoveries by the Weill Cornell team, we fortuitously disclosed in September of 2010 that our Aethlon Hemopurifier® was able to capture exosomes derived from individuals with metastatic melanoma in a pre-clinical study. At present, we are fully focused on participating in a response to a new DARPA contract opportunity, expanding our HCV treatment studies, and preparing the resubmission of a investigational device exemption to FDA. Once these objectives have been advanced, we plan to discuss a potential melanoma treatment study that a U.S. based cancer research institute has proposed to conduct as a result of the Weill Cornell discoveries.
About Aethlon Medical
The Aethlon Medical mission is to create 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 therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
All financial disclosures, anticipated revenue recognition amounts and other information related to the financial results and operations of the Company set forth above are unaudited and are subject to year-end audit adjustments and footnote disclosures.
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 FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies of the Aethlon ADPAT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies or as a standalone cancer 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
SOURCE Aethlon Medical, Inc.