SAN DIEGO, Dec. 8 Aethlon Medical, Inc., (OTC Bulletin Board: AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
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To our Shareholders:
In my September 15th shareholder letter, I indicated that we initiated the program with Bioserv/NextPharma to produce our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. Today, I am pleased to report that we have now established our GMP manufacturing processes. Furthermore, we kicked-off our inaugural production run yesterday, which should allow us to commence with our first Hemopurifier® shipments in February. The task of establishing manufacturing of our Hemopurifier® under GMP was an intricate process requiring significant expertise and a focused commitment among many participants. I applaud the tireless efforts of Dr. Richard Tullis, Paul Duffin, and our colleagues at Bioserv/NextPharma.
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The initial commercialization of our Hemopurifier® remains focused towards treating individuals infected with Hepatitis-C virus (HCV) at select medical centers in India. At present, fewer than half of HCV-infected individuals who initiate the 48-week interferon-ribavirin standard of care (SOC) drug regimen successfully respond to treatment. With an estimated 180 million people infected worldwide, a monumental need exists for adjunct therapies that can improve HCV cure rates without increasing the considerable toxicity already associated with SOC therapy. In this regard, we have established a data-supported strategy that provides an opportunity to play a central and enduring role in HCV care. Our strategy uniquely positions our Hemopurifier® to enhance the benefit of SOC therapy even if the drug combinations underlying SOC become redefined.
While our Hemopurifier® is the first-in-class device to selectively capture viruses and immunosuppressive proteins from circulation, the precedent for a device to treat HCV was established by Asahi Kasei Kuraray Medical (Asahi), who validated that moderate levels of viral filtration at the outset of SOC therapy improves cure rates. Asahi demonstrated that their multi-cartridge approach, which is marketed in Japan as V-RAD, was able to achieve 71.4% cure rates in HCV patients who previously failed SOC therapy. In Asahi's studies, V-RAD was administered once daily for three consecutive days at the outset of SOC therapy and provided an average viral load reduction of 26.1% during each treatment period, which averaged 3 1/4 hours in duration. Amazingly, such outcomes were achieved without a further need for viral filtration during the remaining 47+ weeks of SOC therapy.
On October 30th, we reported HCV treatment outcomes at the 42nd Annual American Society of Nephrology (ASN) Conference. When analyzing Hemopurifier® treatment data from all of our HCV human studies, we documented average per-treatment viral load reductions of 29-42%. While the length of each Hemopurifier® treatment was similar in duration to V-RAD, the Hemopurifier® did not benefit from SOC associated viral load reductions as our results were achieved in the absence of SOC therapy. We acknowledge and appreciate that V-RAD has indeed documented that viral filtration improves HCV treatment outcomes. However, we believe the Hemopurifier® delivers the necessary capabilities to establish broad-market acceptance of medical device in infectious disease care. Foremost of these capabilities is our ability to selectively capture infectious viruses and immunosuppressive proteins not addressed by V-RAD. The selective capture of deleterious agents from circulation establishes an environment that permits continuous or aggressive intermittent treatment strategies that can truly optimize patient outcomes. Whereas historic therapeutic filtration approaches, including V-RAD, are restricted in scope as they indiscriminately remove particles from blood by molecule size. As a result, the safe application of such treatments remains limited as beneficial blood components required for health are removed along with the deleterious target.
In the face of a challenging economic climate, we have reached a pivotal stage that positions us to capitalize on the sum of our efforts during the last decade. We have not deviated in our vision to evolve what once existed as a theoretical concept into the reality of a device that could change the lives of those afflicted with HCV and other infectious disease conditions. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements within this shareholder letter 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 capability of the Hemopurifier® to reduce viral loads and other 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 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.
Contacts:Jon CunninghamRedChip Companies Inc.(407) 644-4256(407) 491-4498 [email protected] or [email protected] JoyceChairman, CEO858.459.7800 [email protected] FrakesSenior VP Finance858.459.7800 [email protected]
SOURCE Aethlon Medical, Inc.
