Aethlon Medical (AEMD) Note: New Government Contract, Resubmission of IDE to Treat Hepatitis C (HCV), Biothreat Legislation Signed into Law by President Obama
Published: Apr 16, 2013
SAN DIEGO, April 16, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
As disclosed in yesterday's SEC form 8-K submission, we entered into a subcontract agreement with Battelle Memorial Institute (Battelle) to provide services underlying a $22.8 million prime contract that was recently awarded to Battelle by the Defense Advanced Research Projects Agency (DARPA). The objective of this contract program is to integrate component technologies developed in DARPA's Dialysis Like Therapeutics (DLT) program into medical device that would save military and civilian lives by effectively treating sepsis. Beyond expanding our opportunity in the DLT program, we are honored to have the opportunity to work with Battelle (the world's largest independent research and development organization) on this endeavor.
We were previously awarded a $6.8 million contract from DARPA to develop two technology components in the DLT program. Our first component objective has been the development of a therapeutic cartridge that selectively eliminates septic precursors, bacterial toxins, viral pathogens, and disease enhancing exosomes from the entire circulatory system. Our second component objective is the creation of a blood processing system that would allow for the delivery of various extracorporeal therapies without the need to administer systemic anticoagulants. We are now in year two of this five-year contract and have achieved eleven DLT milestone objectives to date.
On a different front, I am pleased to share that we resubmitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) on March 25th. Our goal is to receive permission to initiate a clinical feasibility study of Hepatitis-C (HCV) infected individuals who would be enrolled to receive Hemopurifier® therapy. An update on this effort should be available in the coming weeks. As reported from clinical studies conducted overseas, a three-treatment Hemopurifier® protocol administered in combination with interferon-based standard-of-care resulted in undetectable HCV in as little at seven days in hard to treat genotype-1 patients.
The proven ability of our Hemopurifier® to capture a broad-spectrum of viral pathogens (see: www.aethlonmedical.com/assets/001/5040.pdf ) might also set the stage for us to revisit opportunities related to the treatment of drug and vaccine resistant agents. While funding for many healthcare programs has been cut as a result of sequestration, I am pleased to report that the funding spigot for countermeasures against bioterror and pandemic threats has been turned back on. Last month, The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013 was signed into law by President Obama. The law reauthorizes provisions of the Project Bioshield Act of 2004 and extends the mandate of the Biomedical Advanced Research and Development Authority (BARDA) to support medical countermeasure development for biothreat agents for possible inclusion in the U.S. Strategic National Stockpile. PAHPRA also enhances the authority of the FDA to support rapid responses to public health emergencies by clarifying that even before an event occurs, FDA may issue an emergency use authorization to allow emergency use of certain products as medical countermeasures. The Congressional Budget Office estimates that $11 billion will be spent on PAHPRA between fiscal years 2014 to 2018.
The scope of PAHPRA 2013 legislation includes the support of treatment countermeasures against bioterror threats created by man as well as naturally emerging threats, such as the H7N9 strain of bird flu that has triggered 13 reported deaths in China. Health officials are concerned that humans may have no natural immunity to H7N9, as it had not been previously detected in humans. Additionally, clinical trials of candidate vaccines against other H7 viral strains have not been able to induce an immune response, even when administered in very large doses. And, unlike the recent H5N1 bird flu outbreak, the H7N9 strain does not seem does not seem to cause significant illness in birds themselves. As a result, tracking and containing the spread of the virus could be an immense challenge. The good news is that H7N9 has not evolved to spread easily within human populations. However, it establishes a compelling rationale for why emerging non-vaccine technologies such as our Hemopurifier® need to be tested. Previously, the Hemopurifier® was validated to capture the H5N1 bird flu virus, the H1N1 swine flu virus and the reconstructed Spanish flu virus of 1918, which triggered the deaths of approximately 50 million people worldwide.
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 approval of the Company's technologies or products as a treatment against pandemic threats, 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.