AEMD,Aethlon Medical Completes Human Safety Study
Business Wire - April 19, 2006 10:07
SAN DIEGO, Apr 19, 2006 (BUSINESS WIRE) -- Aethlon Medical, Inc. (OTCBB:AEMD), a pioneer in developing therapeutic devices for infectious disease, announced today that a safety study of patients treated with the Aethlon Hemopurifier(TM) has been successfully completed at the Apollo Hospital in Delhi, India. Aethlon will include data from the study in Pandemic Influenza and Class "A" Biological Weapon regulatory filings to be submitted to the Food and Drug Administration (FDA). The demonstration of safety represents the sole human challenge for therapeutic candidates seeking clearance to treat these indications in the United States. Dr. Vijay Kher, the principal investigator of the safety study, now plans to initiate human efficacy studies of the Hemopurifier(TM) as a treatment for chronic and acute viral conditions in India. Aethlon management is currently working with Dr. Kher, advisors at Qualtran, LLC, and government officials in India to determine the infectious disease target of the initial efficacy study.
A Review of the Safety Study
Aethlon demonstrated treatment safety of the Hemopurifier(TM) in all patients enrolled in the study. Each patient suffered from end-stage renal disease (requiring kidney dialysis treatment) as well as Hepatitis-C (HCV) infection. A total of four patients met the conditions to be enrolled and were treated in the study. The average patient age exceeded 50 years, and as a result of their severe condition, spent greater than 50% of their waking hours in bed. The treatment regimen required each patient to be treated six times with the Hemopurifier over a two-week time frame. Each treatment lasted four hours. The treatment regimen mirrored the patient's normal kidney dialysis schedule, which allowed for the inclusion of the Hemopurifier(TM) without disrupting dialysis treatment. Blood chemistry and general health of the patients were monitored throughout the study, and at the conclusion of the study, no material adverse events had been observed. In addition to demonstrating safety, Aethlon researchers observed an approximate 30% capture of circulating HCV during each examined four-hour treatment. Blood samples from the first and last treatment sessions were sent to independent labs to seek further validation. These results were deemed uninterruptible as the same blood samples yielded up to a four-fold variance in viral load measurements from the two participant labs. "The completion of our first human study represents our most significant milestone to date," stated Aethlon Chairman and CEO, James A. Joyce. "The recruitment of patients meeting the criteria of being afflicted with both kidney failure and Hepatitis-C did cause significant delay." "However, the demonstration of safety in individuals with such severely compromised health conditions will be considerably more valuable to our efforts moving forward," concluded Joyce.
About Aethlon Medical
Aethlon Medical is developing the first medical device to treat infectious disease. The device, known as the Hemopurifier(TM), is a broad-spectrum treatment countermeasure against drug and vaccine resistant bioweapons, naturally evolving pandemic threats such as H5N1 Avian Flu, and chronic infectious disease targets including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Aethlon has also initiated research on a second generation Hemopurifier(TM) that targets the capture of growth factors inherent in the spread of Cancer. More information on Aethlon Medical and the Hemopurifier(TM) technology can be found at www.aethlonmedical.com.
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 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.
SOURCE: Aethlon Medical, Inc.
Aethlon Medical, Inc.
Jeff Richardson, 858.459.7800 x302
jrichardson@aethlonmedical.com
James A. Joyce, 858.459.7800 x301
jj@aethlonmedical.com
Copyright Business Wire 2006
Market Data 
Markets 
AI
