Healthcare Industry News: pegylated interferon
News Release - March 11, 2009
Aethlon Medical Announces Significant Viral Load Reduction in Landmark Medical Device Study to Treat HIV/AIDSThe Aethlon Hemopurifier® Now Proven to Reduce Both HIV and Hepatitis-C (HCV) Viral Load in Human Studies
SAN DIEGO--(HSMN NewsFeed)--Aethlon Medical, Inc. (OTCBB:AEMD ) today announced results of the “first-in-man” study of the Aethlon Hemopurifier® to treat Human Immunodeficiency Virus (HIV), the disease that causes Acquired Immune Deficiency Syndrome (AIDS). In the study, viral load was reduced by 92% in an HIV-infected individual who received a total of twelve Hemopurifier® treatments administered thrice weekly over the span of one month. The study, which was conducted in the absence of any antiviral drug therapy, documented initial viral load of 102,759 iu/ml being reduced to 7,960 iu/ml at the conclusion of the study. 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®.
The Hemopurifier® is a therapeutic filtration device that serves as an artificial adjunct to the immune system. 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. Beyond HIV care, the Hemopurifier® is a leading broad-spectrum treatment candidate against drug and vaccine resistant viral pathogens.
“Our first HIV treatment experience supports the vision of our Hemopurifier® becoming a primary strategy to inhibit disease progression once an individual becomes resistant to antiviral drugs,” stated Aethlon Chairman and CEO, Jim Joyce. “Additionally, our device offers a synergistic mechanism of action that could enhance and extend the benefit of both established and candidate antiviral therapies,” concluded Joyce.
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.
The individual enrolled in the Hemopurifier® study 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® therapy. A percentage below 14% 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%. Corresponding CD4 lymphocyte counts decreased from 215 cells/µL to 168 cells/µL. 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® treatment. The principle 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 principle investigator. All viral load measurements were performed with real-time quantitative polymerase chain reaction (RT-PCR), with treatment samples being measured in duplicate.
Based on previous treatment outcomes in Hepatitis-C (HCV) infected patients, Aethlon management believes the Hemopurifier® to be the first therapeutic candidate to demonstrate meaningful viral load reductions in both HIV and HCV infected individuals. According to the Centers for Disease Control and Infection (CDC), about one quarter of HIV-infected persons are also infected with HCV. HCV is one of the most important causes of chronic liver disease and HCV infection progresses more rapidly to liver damage in HIV-infected persons. HCV infection may also impact the course and management of HIV infection. In addition, HIV suppression of the immune system reduces patient ability to tolerate the HCV standard of care.
Beyond the potential to treat individuals infected with both HIV and HCV, the opportunity for the Hemopurifier® in HCV care is significant, as approximately 170 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.
In studies of HCV infected individuals, treatment with the Hemopurifier® resulted in robust viral load reductions in HCV patients who completed a treatment protocol of three, 4-hour Hemopurifier® treatments every other day during the course of one week. The study was conducted at the Fortis Hospital in Delhi, India.
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 an 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.
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®, 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® also holds promise in cancer care, as research studies verify the Hemopurifier® effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over sixty-five (65) Hemopurifier® 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® is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of the 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® 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.
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
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