SAN DIEGO, Dec. 1, 2010 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc., (OTC Bulletin Board: AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
(Photo: http://photos.prnewswire.com/prnh/20090325/LA88762LOGO-b)
To our Shareholders:
I was recently invited to participate in a private gathering, which primarily included leaders from the biotechnology and pharmaceutical industry. During the event, a reoccurring theme was the need for innovative new treatment strategies as escalating regulatory challenges have made it nearly impossible for small and micro-cap drug developers to commercialize therapeutic candidates without significant support from large biotechnology or pharmaceutical organizations.
I believe the life sciences industry will receive this needed source of innovation from medical device companies that create products which can be combined with traditional therapeutics to improve patient outcomes. In this regard, current and future iterations of our Hemopurifier® platform technology allow us the opportunity to establish a leadership position across large and diverse infectious disease and cancer markets. Unlike our pharma and biotech brethren, we face regulatory hurdles that are much less onerous and our business model provides an expansive application pipeline from one core platform technology. Additionally, there is significantly less ambiguity as to whether or not our Hemopurifier® can capture a harmful virus or cancer-secreted particles from circulation as compared to a drug mechanism of action that may be difficult to fully understand.
So, can medical devices really improve treatment outcomes when combined with traditional drug therapies? I believe the answer is “yes” and would like to refer to a clinical study by Asahi Kasei Kuraray Medical, which successfully demonstrated that a filtration device can have a remarkable effect (see an abstract of study results at: www.ncbi.nlm.nih.gov/pubmed/17573947) on improving cure rates of Hepatitis-C (HCV) infected patients that undergo interferon-ribavirin standard of care (SOC) therapy. In fact, the reported benefits of this device when applied in just the first few days of SOC therapy (48-week regimen) seem to rival or exceed the benefit of adjunct drug strategies currently being advanced in HCV care.
We believe the selective nature of our Hemopurifier® to capture HCV as well as immunosuppressive particles shed by the virus will further improve upon the ability of a medical device to improve the benefit of HCV drug therapy. This month, we will test our beliefs as we expect to initiate clinical studies to demonstrate the ability of our Hemopurifier® to accelerate viral load depletion when administered at the outset of SOC drug therapy (access study details at: http://aethlonmedical.investorroom.com/index.php?s=43&item=61). If successful, we will have an enduring opportunity to improve the lives of HCV infected individuals as an adjunct to current and future iterations of SOC drug therapy.
Still, I have always asked the question, what if we could safely deliver the benefit of a portable Hemopurifier® that gave HCV patients the ability to treat themselves in the convenience of their own home during the entire duration of SOC drug therapy? Can you imagine? Well, those of you who read the November 18th report entitled, “A Platform Technology to Address Bioterrorism” may have noted the paragraph:
“We have also initiated development of a second generation Hemopurifier® that allows for increased portability, expands blood access options, and enhances viral pathogen clearance. A tested prototype of this device has demonstrated a 5 to 7 fold increase in viral clearance in studies conducted by our researchers.”
In this regard, I hope you fully appreciate the strategic nature of hiring Rod Kenley as our new President on October 28th, as I am not aware of any one individual more capable of transitioning therapeutic filtration technology from the clinic and into the home. During Rod’s tenure at Baxter, he conceived of and managed the launch of several new products including the HomeChoice peritoneal dialysis cycler, which allowed patients the portability to treat at home or while traveling. Rod then started Aksys, Ltd. which developed and commercialized his concept of daily home hemodialysis, which untethered patients from being bound to receiving treatment in dialysis clinics. In a similar fashion, it seems reasonable that our clinic-based Hemopurifier® could impact HCV care in the years to come and seed future demand for a revolutionary in-home therapy system.
In closing, we are energized by the belief we can improve the lives of patients across diverse disease conditions. Because we have challenged long accepted treatment paradigms, our vision of commercializing a device to improve HCV treatment outcomes is moving ever closer to a reality.
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 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 capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such ascancer, 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 ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier® to improve the efficacy of SOC therapy against HCV, the Company’s ability to manufacture its products either internally or through outside companies and to create future generations of the Hemopurifier®, 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.
CONTACT: John Salvador (858) 459-7800 x 307, jps@aethlonmedical.com
SOURCE Aethlon Medical, Inc.
