SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD) today disclosed new data resulting from its recent "first-in-human" application of the Aethlon Hemopurifier(R) to treat Human Immunodeficiency Virus (HIV), the disease that causes Acquired Immune Deficiency Syndrome (AIDS). Aethlon announced that an HIV-infected individual, who received twelve Hemopurifier(R) treatments during the span of one month, had an average viral load reduction of 55% during each four-hour Hemopurifier(R) treatment. The study was conducted in the absence of any antiviral drug therapy. Based on this data, mathematical treatment models of approximately 1.5 days of continuous Hemopurifier(R) treatment would reduce patient viral load to undetectable levels. The study, which was conducted at the Sigma New Life Hospital in Punjab, India, was designed to provide insight that will define future clinical programs and commercialization pathways for the Aethlon Hemopurifier(R).
"Our initial observations from the HIV study validated that our Hemopurifier(R) could inhibit and reverse HIV disease progression in the absence of antiviral drugs," stated Aethlon Chairman and CEO, Jim Joyce. "We now have additional insight that suggests we could quickly reset viral loads to undetectable levels, which supports our belief that the Hemopurifier(R) could significantly enhance and extend the efficacy of both established and candidate drug regimens," concluded Joyce.
The Hemopurifier(R) is a first-in-class medical technology that assists the immune response in combating infectious disease through the selective adsorption of circulating viruses and immunosuppressive proteins. In HIV care, the Hemopurifier(R) targets the clearance of all circulating strains of infectious HIV, including varieties that cause patients to fail antiviral drug regimens. Additionally, the device assists to preserve the immune response through the removal of gp120 and other toxic proteins that shed from HIV to kill-off immune cells, the hallmark of AIDS. Since the beginning of 2009, the Hemopurifier(R) has been demonstrated safe and effective in reducing patient viral load in both Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections. As a result, Aethlon believes the Hemopurifier(R) is the first therapeutic candidate to demonstrate viral reduction benefit against two different viral species in human studies.
Aethlon previously reported that viral load was reduced by 92% in the HIV-infected individual treated in the Hemopurifier(R) based on initial viral load of 102,759 iu/ml being reduced to 7,960 iu/ml at the conclusion of the study. The subject patient had end-stage renal disease (ESRD) and was clinically defined as having AIDS based on a CD4+ T-cell percentage of total lymphocytes of 13.5% at the outset of Hemopurifier(R) therapy. A percentage below 14% is a defining event that indicates HIV infection has progressed to AIDS. By the end of the Hemopurifier(R) study, CD4+ T-cell percentage of total lymphocytes increased to 18.09%. Corresponding CD4 lymphocyte counts decreased from 215 cells/uL to 168 cells/uL. Post study follow-on testing indicated that HIV viral load was 57% lower (43,398 iu/ml) than initial study values when measured 14-days after administration of the last Hemopurifier(R) treatment. The principal investigator of the study reported the patient felt an improved sense of well being, including increased energy and appetite during the study. There were no observed adverse events reported by the principal investigator. All viral load measurements were performed with real-time quantitative polymerase chain reaction (RT-PCR), with treatment samples being measured in duplicate.
The outcome of the study fulfilled the challenge underlying a recent grant submission to the Bill & Melinda Gates Foundation to demonstrate that an artificial adjunct to the immune system can reduce viral load and improve immune function in an HIV infected individual. Aethlon has been advised by the Gates Foundation that it not a recipient of a Grand Challenges II grant but has been encouraged to refine its proposal and resubmit for a Gates Foundation Grand Challenges III Global Health grant.
According to the World Health Organization, an estimated 33 million people worldwide are infected with HIV, the virus that causes AIDS, and last year 2.2 million people died of AIDS-related illnesses. While there is no cure, HIV antiviral drug regimens have allowed people to live longer with HIV infection. Over time, resistance to these medications can evolve to eliminate the benefit of antiviral drugs, thus leaving infected individuals without further treatment options.
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. Aethlon's lead product, the Hemopurifier(R), is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from the human circulatory system. The device targets to inhibit disease progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV), and serves as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The Hemopurifier(R) also holds promise in cancer care, as research studies verify the Hemopurifier(R) effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over sixty-five (65) Hemopurifier(R) treatments (representing approximately 260 hours of treatment time) have been conducted in multi-site studies at the Apollo Hospital, Fortis Hospital, and Sigma New-Life Hospital in India. The studies enrolled end-stage renal disease (ESRD) patients infected with either HCV or HIV. In addition to establishing treatment safety, robust viral load reductions have been reported in both HCV and HIV infected individuals.
Research studies have also demonstrated the Hemopurifier(R) is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of world's deadliest bioterror and pandemic threats. These include: Dengue hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF), Lassa hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), the reconstructed 1918 influenza virus (r1918), West Nile virus (WNV), and Vaccinia and Monkeypox (MPV), which both serve as models for human smallpox infection. The studies were conducted with the assistance of researchers representing: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID); The Centers for Disease Control and Prevention (CDC); The National Institute of Virology (NIV); The Battelle Biomedical Research Center (BBRC); and The Southwest Foundation for Biomedical Research (SFBR).
Beyond therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier(R) technology platform to establish a pipeline of clinical and research diagnostic products and services. Additional information regarding Aethlon Medical can be accessed online at www.aethlonmedical.com.
Contacts: Dave Gentry or Jon Cunningham RedChip Companies Inc. (407) 644-4256 (407) 491-4498 -cell Dave@redchip.com Jim Joyce Chairman, CEO 858.459.7800 x301 firstname.lastname@example.org Jeff Richardson Senior Director, Communications 858.459.7800 x302 email@example.com Jim Frakes Senior VP Finance 858.459.7800 x300 firstname.lastname@example.org
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(R) 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.
|SOURCE Aethlon Medical, Inc.|
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