SAN DIEGO, Jan. 24, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
Yesterday, our President Rod Kenley presented an informative review of extracorporeal medical device strategies to treat sepsis at the 15th International Conference on Dialysis. He also had the opportunity to discuss some of the advances we have made in the field. If you are not familiar with sepsis, it is a life-threatening blood infection that can trigger multiple organ failure and is a leading cause of death in intensive care units (ICU). 18 million cases of sepsis are diagnosed around the globe each year and candidate drug therapies have yet to demonstrate an ability to significantly improve survival rates.
When we initiated our sepsis research, the prevailing viewpoint seemed to be that sepsis was triggered by a hyperactive response of the immune system in an attempt to respond to overwhelming infection. This response is often called a "cytokine storm." As a result of this predominant viewpoint, many experimental therapies solely focused on modulating the early inflammatory response phase of sepsis and did so without much success. As it turns out, sepsis is far more complex as the exuberant inflammatory immune response occurring at the outset of sepsis is soon followed by a period of significant immune suppression. Thus, therapies solely focused on the knocking down the initial immune response may actually accelerate the development of immunosuppression, which is associated with a majority of deaths in sepsis. In other words, while sepsis is triggered by a hyper activation of the immune response, most sepsis patients actually die from immune paralysis.
As Rod points out in his presentation, evidence suggests that a successful extracorporeal strategy will have the ability to selectively eliminate multiple sepsis promoting factors from circulation without disrupting the production of anti-inflammatory cytokines or other elements that might further exasperate immune suppression. This is the focus of a strategy we are proudly advancing with industry colleagues under a contract with the Defense Advanced Research Projects Agency (DARPA).
There is also an additional factor to consider. An increasing number of scientific journals are reporting evidence that sepsis related immune suppression reactivates latent viruses such as cytomegalovirus (CMV) and other herpes viruses in critically ill patients, which in turn can increase the severity of sepsis, lengthen the stay in the ICU and increase patient mortality rates. In one recent publication, active CMV infection was associated with an 81% higher mortality rate as compared to critically ill patients without active CMV infection. Cytomegalovirus, or CMV, is a herpes virus found in more than half of the U.S. population over age 40. Like other herpes viruses, CMV can remain dormant inside cells for years, causing little or no apparent illness in healthy people. But in those with weakened immune systems, such as organ transplant recipients, people receiving chemotherapy, or people with AIDS, reawakening of the virus can cause serious complications or even death.
In previously conducted studies, our researchers demonstrated that our Hemopurifier® is able to capture CMV. That's right, the same Hemopurifier® we are actively advancing in the treatment of Hepatitis C virus (HCV). As such, we cannot ignore the possibility that our Hemopurifier® could have utility during the immunosuppressive phase of sepsis. In Rod's presentation, he also reports evidence that the affinity agent immobilized in our Hemopurifier® to facilitate selective yet rapid clearance of circulating viral and cancer promoting targets is able to bind lipopolysaccharide (LPS) and other factors implicated in the pathogenesis of sepsis. Perhaps these findings in combination with industry colleague advances will lead to a device that saves the lives of sepsis patients.
Rod's presentation is now accessible online at: http://aethlonmedical.investorroom.com/index.php?s=19.
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.
About The Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of infectious viral pathogens and immunosuppressive proteins from the entire circulatory system. In the treatment of Hepatitis C virus (HCV), human studies have demonstrated that Hemopurifier® therapy may improve immediate, rapid and sustained virologic response rates when administered in the first few days of standard-of-care drug therapy. In addition to accelerating viral load depletion, post-treatment analysis of the Hemopurifier® has documented the capture of up to 300 billion HCV copies of HCV during a single six-hour treatment. Access to Hemopurifier® therapy is available on a compassionate-use basis through the Medanta Medicity Institute (Medicity), a leading center for medical tourism in India. The Medicity is offering treatment access to infected individuals who previously failed or subsequently relapsed standard-of-care drug regimens. The Hemopurifier® is also being offered as a salvage therapy to infected individuals who suffer a viral breakthrough during standard-of-care therapy. U.S. studies of the Hemopurifier® are currently pending approval of an IDE submitted to FDA.
The Aethlon Hemopurifier® and Cancer
In addition to the opportunity to address a broad-spectrum of infectious viral pathogens, the Hemopurifier® has been discovered to capture tumor-derived exosomes underlying several forms of cancer. Tumor-derived exosomes have recently emerged to be a vital therapeutic target in cancer care. These microvesicular particles suppress the immune response in cancer patients through apoptosis of immune cells and their quantity in circulation correlates directly with disease progression. Beyond possessing immunosuppressive properties, tumor-derived exosomes facilitate tumor growth, metastasis, and the development of drug resistance. By addressing this unmet medical need, the Hemopurifier® is positioned as an adjunct to improve established cancer treatment regimens.
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 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 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.