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Aethlon releases data on Hemopurifier’s ability to treat HIV

Aethlon Medical : 06 May, 2009  (Company News)
Aethlon Medical releases new data resulting from its recent ‘first-in-human’ application of the Aethlon Hemopurifier 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 treatments during the span of one month, had an average viral load reduction of 55 percent during each four-hour Hemopurifier 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 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.

'Our initial observations from the HIV study validated that our Hemopurifier could inhibit and reverse HIV disease progression in the absence of antiviral drugs,' stated Aethlon Chairman and Chief Executive Officer, Jim Joyce. 'We now have additional insight that suggests we could quickly reset viral loads to undetectable levels, which supports our belief that the Hemopurifiercould significantly enhance and extend the efficacy of both established and candidate drug regimens.'

The Hemopurifier 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 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 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 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 percent in the HIV-infected individual treated in the Hemopurifier 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 percent at the outset of Hemopurifier(R) therapy. A percentage below 14 percent is a defining event that indicates HIV infection has progressed to AIDS.

By the end of the Hemopurifier study, CD4+ T-cell percentage of total lymphocytes increased to 18.09 percent. 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 percent lower (43,398 iu/ml) than initial study values when measured 14-days after administration of the last Hemopurifier 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 and 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.
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