24 Apr, 2012, 09:30 ET
SAN DIEGO, April 24, 2012 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
The gold standard for determining drug therapy benefit against infectious disease targets is to measure changes in patient viral load, otherwise known as the amount of virus that is detectable in circulation. Specific to Hepatitis C virus (HCV), the best predictor of whether a treated patient will achieve a long-term viral cure is the period of time it takes to first achieve undetectable viral load. We recently disclosed that the administration of Hemopurifer® therapy during the first three days of peginterferon+ribavirin (PR) drug therapy resulted in observations of immediate (IVR) and rapid virologic responses (RVR) in hard-to-treat genotype-1 patients. IVR is a 2-log or 100 fold reduction of HCV viral load at day-7. Such a response correlates with 90+% viral cure rates, yet is observed in less than 5% of patients who receive PR therapy alone. RVR is defined as undetectable HCV viral load at day-30 of treatment and correlates with viral cure rates of 86.2%, which is observed in only 10.35% of patients who initiate PR therapy.
In this note, I will discuss an unprecedented data point that further validates the potential of Hemopurifier® therapy to improve the benefit of current interferon-based and emerging all-antiviral drug regimens. This same data point also provides further evidence that may help to explain our recent IVR and RVR treatment observations.
As the result of a collaborative discussion with reviewers at the Center for Devices and Radiological Health (the FDA branch responsible for approving medical devices in the US), our researchers initiated an effort to establish a protocol that would quantify the amount of HCV captured within our Hemopurifier® during a single treatment application. This would first entail a post-treatment preparation for each Hemopurifier®, which would then need to be frozen until ready for shipment on dry ice. This process is still being perfected as two of the first three cartridges analyzed were badly cracked. The next step was to establish a repeatable protocol methodology that would allow biological fluid to be eluted from within the Hemopurifier® so that PCR, the standard for measuring viral copies, could be utilized to validate and quantify the capture of HCV during treatment. The results were compelling.
In the two cracked cartridges referenced above, our researchers recovered and measured the capture of 145 million and 353 million copies of HCV. However, when the fully intact Hemopurifier® was analyzed, our researchers recovered and measured that 300 billion (300,000,000,000) copies of HCV had been captured during a single six-hour treatment. For those viruses captured, the possibility of continued progeny virus replication was eliminated. I applaud our research team for establishing this unprecedented data point, which defines the contribution our Hemopurifier® can provide to current and future HCV treatment regimens. Additionally, this data point serves as a model for capture capacity of other disease enhancing particles, whether they be associated with cancer, sepsis or other viral conditions.
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 the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the 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, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to capture hepatitis c virus, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, 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.
James A. Joyce
Chairman and CEO
Chief Financial Officer
John P. Salvador
SOURCE Aethlon Medical, Inc.
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