Aethlon Medical (AEMD) CEO Note: Hemopurifier Clinical Progression, USA Today on the Next Zika, Combating Bioterror & Pandemic Threats
SAN DIEGO, May 2, 2016 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
At present, we are conducting the first FDA approved study of Hemopurifier® therapy as a candidate broad-spectrum countermeasure against viral diseases. While a transition of principal investigators contributed to a slow start, the pace of our study is now progressing. On March 31st, we disclosed that our new principal investigator had administered a six-treatment protocol of Hemopurifier therapy to an enrolled patient and had consented the enrollment of a second patient. Since that disclosure, the consented patient has completed our treatment protocol and a third patient has been enrolled and initiated the study protocol, which upon completion will represent a total of four treated patients who met the inclusion criteria. The study calls for a total enrollment of 10 patients.
Upon successful completion, the study will support the advancement of our Hemopurifier as a broad-spectrum treatment countermeasure against bioterror and pandemic threats and will also provide a pathway into pivotal studies of chronic viral diseases that allow for controlled human efficacy studies to be conducted.
Previous preclinical and clinical validations suggest that our first-in-class technology could address significant unmet needs in infectious disease. Especially, when considering the impossibility of aligning a traditional drug or vaccine agent with each and every pathogen threat. Of the hundreds of viruses known to be infectious to man today, fewer than ten are addressed with proven antiviral drug therapies. This is not inclusive of new viral threats that emerge naturally or are released by man as agents of bioterrorism. Beyond the recent Ebola and Zika outbreaks, a proliferation of international travel, urban crowding and global warming will contribute to fuel the emergence of future pandemic threats.
Last week, former U.S. Senate Majority Leader, Tom Daschle and former White House Ebola Response Coordinator, Ron Klain authored an editorial in the USA Today entitled: "We're not ready for the next Zika virus". The editorial further reinforces the need for medical countermeasure to treat bioterror and pandemic threats.
In regards to pandemic threats, the authors stated that in the aftermath of the anthrax attacks of 2001, the Ebola outbreak of 2014 and now Zika, it is no longer a question of if but when the next biosecurity threat will occur. That experts believe a pandemic, not nuclear terrorism or climate change, is most likely to cause 10 million or more deaths in a single event.
In regards to bioterror threats, the authors shared what President Obama's National Security Council noted in 2009, "The effective dissemination of a lethal biological agent within an unprotected population could place at risk the lives of hundreds of thousands of people. The unmitigated consequences of such an event could overwhelm our public health capabilities, potentially causing an untold number of deaths. The economic cost could exceed one trillion dollars for each such incident." The authors point out that numerous commissions and panels have concluded that biological threats have the potential for catastrophic consequences within the United States, and have provided recommendations for a path forward. In conclusion, the authors ask if policy-makers will finally act?
From our perspective, we have observed that policy-makers have indeed been taking steps to protect U.S. citizens. Evidence of such steps can be found in the 2015 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP), which describes the priorities that the U.S. Department of Health and Human Services (HHS), in collaboration with its interagency partners, will implement over the next five years to protect against bioterror and emergency pandemic threats. A primary objective of the PHEMCE SIP includes the advancement of platform technology medical countermeasures with broad-spectrum capabilities. Based on preclinical studies and human treatment experiences, the Aethlon Hemopurifier defines this objective.
To date, Hemopurifier therapy has been successfully administered to individuals infected with Ebola, Hepatitis C and the Human Immunodeficiency virus (HIV). In the case of Ebola, a remarkable response to a single 6.5-hour administration of Hemopurifier therapy (comatose physician with multiple organ failure at the time) was presented at the American Society of Nephrology Annual Meeting and subsequently published in a peer-reviewed scientific journal. The physician made a full recovery and returned home to his wife and children.
Beyond human treatment experiences, pre-clinical Hemopurifier studies (reported to date) have validated the capture of many high-priority viral threats. These include: Chikungunya, Dengue and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human smallpox infection. Specific to pandemic influenza threats, we have validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which represents a model for the strain of influenza that killed an estimated 20 million to 50 million victims in 1918 and 1919. In vitro studies of other viral threats are ongoing.
While these clinical experiences may help to reinforce the validity of our broad-spectrum therapeutic vision, we also understand that continued clinical progression is necessary to unlock the true value of our endeavors.
Chairman and CEO
About Aethlon Medical, Inc.
Aethlon Medical (Nasdaq:AEMD) creates affinity biofiltration devices to treat life-threatening diseases. The Aethlon Hemopurifier® is a leading broad-spectrum treatment countermeasure against infectious viral pathogens. The device, which has been successfully administered to individuals infected with HIV, Hepatitis C (HCV) and Ebola virus, is currently the subject of FDA approved clinical studies. Aethlon is also studying the potential use of the Hemopurifier® to address exosomes secreted by tumors to promote the spread of metastasis and suppress the immune system of cancer patients. The Company provides government contracting services to the Defense Advanced Research Projects Agency (DARPA) related to the development of a biofiltration device to treat sepsis and maintains majority ownership of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor Chronic Traumatic Encephalopathy (CTE) and other neurological disorders. Additional information can be found online at www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn, Facebook and Google+.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, the Company's ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, that the FDA will not approve the initiation or continuation of the Company's clinical programs or provide market clearance of the Company's products, including products developed by Exosome Sciences, Inc., 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, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2015, and in the Company's other filings with the Securities and Exchange Commission. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Mike Smargiassi/Brad Edwards
Brainerd Communicators, Inc
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SOURCE Aethlon Medical, Inc.
Released May 2, 2016