I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on October 14, 2008, 10:47:09 AM
-
Aethlon Medical Announces Completion of Human Safety Study
Reports Further Results of Hepatitis-C Patients Treated With the Aethlon Hemopurifier(R)
Last update: 6:45 a.m. EDT Oct. 14, 2008
SAN DIEGO, Oct 14, 2008 (BUSINESS WIRE) -- Aethlon Medical, Inc. (OTCBB:AEMD) today announced the completion of a human safety study conducted at the Fortis Hospital in Delhi, India. The primary objective of the study was to evaluate the safety of the Aethlon Hemopurifier(R) in health compromised end-stage renal disease (ESRD) patients that require kidney dialysis. The Hemopurifier(R) is a first-in-class medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins. In addition to demonstrating safety, the study provided the opportunity to observe changes in viral load in ESRD patients infected with Hepatitis-C virus (HCV).
In the study, six ESRD patients received a series of three, 4-hour Hemopurifier(R) treatments every other day during the course of one week. The treatment regimen mirrored the patient's normal kidney dialysis schedule, which allowed for the inclusion of the Hemopurifier(R) without disrupting dialysis treatment. Blood chemistry and general health of the patients were monitored throughout the study, and at the conclusion of the study, the sole reported adverse event was hemolysis, which was observed in a total of four treatments, three of which occurred in the same patient. The physicians administering the study reported that the incidence of hemolysis did not cause any follow-on health concerns. No other adverse events have been reported in a total of 42 Hemopurifier(R) treatments administered in human studies. Aethlon previously completed a 24-treatment study at the Apollo Hospital, also located in Delhi.
Updated HCV Data
On September 17, 2008, Aethlon reported robust viral load reductions in tested HCV patients that completed the three Hemopurifer(R) treatment protocol. The outcomes were derived from consolidated viral load values of all three patients. The values resulted in an average viral load reduction of 60% when measured three days after final Hemopurifier(R) treatment, and an 82% reduction when measured seven days post treatment. Since this report, follow-on data provides for HCV viral load values to be calculated on an individual, patient by patient basis.
Patient #1 had a 95% reduction three days post treatment and 89% reduction seven days post treatment. The initial viral load for patient 1 was 5.3 x 10(5) viral units per ml of blood (IU/ml). Patient 1's viral load seven days post treatment was 5.7 x 10(4) IU/ml.
Patient #2 had a 85% reduction three days post treatment and 50% reduction seven days post treatment. The initial viral load for patient 2 was 9.2 x 10(6) IU/ml. Patient 2's viral load seven days post treatment was 4.6 x 10(6) IU/ml.
Patient #3 had a 60% reduction three days post treatment and 83% reduction seven days post treatment. The initial viral load for patient 3 was 3.0 x 10(8) IU/ml. Patient 3's viral load seven days post treatment was 5.1 x 10(7) IU/ml. All viral load measurements were performed with real-time quantitative polymerase chain reaction (RT-PCR). Control samples were measured in duplicate while treatment samples were generally measured in triplicate.
"With the Fortis study complete, we will update our investigational device exemption on file with the FDA and request permission to initiate human studies in the United States," stated Aethlon Chairman and CEO, James A. Joyce. "Additionally, we are preparing to launch a four-week HCV treatment case study that could trigger early commercialization in India, and we have initiated discussions with potential partners to evaluate the clinical opportunity for our Hemopurifier(R) in the European Union," concluded Joyce.
The opportunity for new antiviral strategies to fight HCV is significant, as approximately 180 million people worldwide (3% of the world's population) are HCV infected. According to the World Health Organization (WHO), only 30-50% of infected patients beneficially respond to the 48-week pegylated interferon-ribavirin treatment standard.
The Hemopurifier(R) is a first-in-class medical device designed to assist the immune response in combating infectious disease by rapidly clearing viruses and immunosuppressive proteins from circulation. The device provides a novel mechanism to complement antiviral therapies by suppressing the emergence of viral strains that cause drug resistance. The Hemopurifier(R) is also positioned to fill the unmet clinical need of treating patients resistant to drug therapy or infected by viral pathogens that are untreatable with drug and vaccine therapy. In HCV care, the device is positioned as an adjunct to improve clinical outcomes of the pegylated interferon-ribavirin treatment standard. Other opportunities in HCV care include the treatment of individuals who fail or are unable to endure standard of care therapy, end-stage renal patients infected with HCV, and HIV patients co-infected with HCV. On September 29th, Aethlon Medical announced that it has further expanded clinical programs by initiating enrollment of HIV-infected patients to be treated with the Hemopurifier(R) in a multi-site clinical program in India.
About Aethlon Medical
Aethlon Medical is the developer of the Hemopurifier(R), a first-in-class medical device designed to treat infectious disease. The Hemopurifier(R) provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and is positioned to address the treatment of drug and vaccine resistant viruses. Additionally, the device holds promise in cancer care, as research studies have verified the Hemopurifier(R) is able to capture immunosuppressive particles secreted by tumors. The Hemopurifier(R) is designed to act both as a stand-alone therapeutic, and as an adjunct treatment to enhance clinical benefit of established therapies. Pre-clinical studies conducted by researchers representing leading government and non-government health organizations both in the United States and abroad have documented the effectiveness of the Hemopurifier(R) in capturing from circulation the viruses that constitute pandemic threats, including H5N1 Avian Influenza (bird flu), and Dengue Hemorrhagic Fever (DHF) from circulation. The company is conducting studies to support the use of the Hemopurifier(R) as a broad-spectrum treatment countermeasure against bioterror threats, including Smallpox, and Ebola, Marburg, and Lassa hemorrhagic fever. Regulatory and commercialization initiatives in the United States are presently focused on bioterror threats, while international initiatives are directed toward naturally evolving pandemic threats, and chronic infectious disease conditions including the Human Immunodeficiency Virus (HIV) and Hepatitis-C (HCV). Aethlon has demonstrated safety of the Hemopurifier(R) in a 24-treatment human study at the Apollo Hospital in Delhi, India, and in an 18-treatment study at the Fortis Hospital, also located in Delhi. The company has submitted an investigational device exemption (IDE) to the U.S. Food and Drug Administration (FDA) to advance the Hemopurifier(R) as a broad-spectrum treatment countermeasure against category "A" bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier(R) technology is available online 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 ext. 302
Senior Director, Communications
jrichardson@aethlonmedical.com
Jim Frakes, 858-459-7800 ext. 300
Senior VP Finance
jfrakes@aethlonmedical.com
James A. Joyce, 858-459-7800 ext. 301
Chairman, CEO
jj@aethlonmedical.com
http://www.marketwatch.com/news/story/aethlon-medical-announces-completion-human/story.aspx?guid={85CDD6AF-8B87-4B8A-B75F-2FE68058E284}&dist=hppr
-
It looks promising but I wonder if it will ever be available to me.