July 14, 2011
Aethlon Medical Releases Shareholder Letter
SAN DIEGO, July 14, 2011 /PRNewswire/ -- Aethlon Medical, Inc., (OTCBB: AEMD) disclosed today that its Chairman and CEO, James A. Joyce, has issued the following letter to shareholders.
Last December, I authored a shareholder letter which referenced the viewpoint of healthcare leaders who felt a need for innovative new therapeutic strategies to evolve as escalating regulatory costs, challenges and uncertainties made it nearly impossible for small to mid-size organizations to commercialize their drug candidates. In response, we introduced the Aethlon ADAPT(TM) (Adaptive Dialysis-Like Affinity Platform Technology) system, as an innovative medical device platform that provides a basis to create new therapeutic devices through the convergence of affinity drug agents and plasma membrane technologies. The Aethlon ADAPT(TM) system provides a previously unrecognized commercialization pathway to antibody and other affinity drug developers, who should also appreciate a less onerous medical device regulatory pathway. We are already seeing evidence of our ADAPT(TM) system being the impetus for industry collaborations that offer new channels of early revenue generation.
On May 25th, we introduced our Aethlon ADAPT(TM) system to the drug industry at the C21 Life Sciences Partnering Conference. However, we had already begun to leverage our ADAPT(TM) system on April 1st, through a response to a government contract opportunity offered by the Defense Advanced Research Projects Agency (DARPA) entitled, "Dialysis-Like Therapeutics." Included within our response was a proposal to develop a device that would reduce the incidence of sepsis in wounded war-fighters. I am pleased to inform you that our submitted program was chosen for funding by a panel of experts assembled by DARPA. While it is an honor to be chosen to receive a contract award, I ask that you curb any assumption that we have won a contract based on information that may be published on the Internet. A contract that leads to funding of our proposed program is predicated on the successful completion of a detailed contracting process. On June 29th, we again leveraged the capabilities of our ADAPT(TM) system through a response to a U.S. Army initiative to create a device that would meet the objective of a program entitled "Blood Purification for Organ Failure."
The genesis of the Aethlon ADAPT(TM) system is our HemopurifierÃ®, a device that has demonstrated broad-spectrum activity against infectious viral pathogens, immunosuppressive proteins and exosomes secreted by cancer. Increasingly, exosomes are being discovered to have implications in other life-threatening diseases. Next Tuesday (July 19th), we will meet with FDA officials to discuss a proposed clinical program to support the regulatory advancement of our HemopurifierÃ® as a treatment countermeasure against bioterror and pandemic threats. Based on data collected from clinical programs conducted in India, we will also seek permission from the FDA to expand our treatment indications to include Hepatitis C virus (HCV). Formal FDA feedback to next week's meeting would likely occur in early fall. Should the FDA grant permission to initiate our U.S. clinical studies, we have already submitted (on May 31st of this year) a request to the Biomedical Advanced Research and Development Authority (BARDA) to fund clinical programs specific to bioterror and pandemic threats. In the meantime, we continue to advance our HCV treatment program at the Medanta Medicity Institute. As previously communicated, positive clinical outcomes from this study will lead to commercialization of our HemopurifierÃ® in India. Regardless of the many challenges we have confronted, we continue to advance our mission to create innovative devices that address unmet medical needs in cancer, infectious disease and other life-threatening conditions. On behalf of your dedicated team at Aethlon Medical, I again thank you for your continued support and belief in our endeavors.
Very truly yours,
James A. Joyce
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(TM) system including consummating government contracts or grants, the FDA's willingness to allow the Company to proceed with the clinical trials proposed in the re-initiation of an Investigational Device Exemption (IDE) study, or the FDA's willingness to meet with company officials to discuss Emergency Use Authorization (EUA) for the HemopurifierÃ® as a broad-spectrum countermeasure against untreatable viral threats, the Company's ability to conduct clinical trials in Europe or to achieve regulatory approval in Europe, the Company's ability to commercialize its HemopurifierÃ® in India, the capability of the HemopurifierÃ® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its 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
Senior Vice President, Lippert/Heilshorn & Associates
Chief Financial Officer
John P. Salvador
Director, Communications & Investor Relations
SOURCE Aethlon Medical, Inc.