Aethlon Medical, Inc. (OTCBB:AEMD), San Diego, has announced that human clinical trials to treat patients infected with the Hepatitis-C virus (HCV) are now underway at the Apollo Hospital in New Delhi, India. The primary objective of the trial is to demonstrate the safety of Aethlon's Hemopurifier(TM) treatment technology. The secondary objective of the trial will be to obtain preliminary efficacy data related to serologic and virologic markers, including viral load measurements before and after treatment with the Hemopurifier(TM).
Aethlon Chairman and CEO, James A. Joyce, stated, "Five years ago, our vision that a device could capture circulating viruses and toxins was purely conceptual. Today, I thank the researchers, advisors, and shareholders who were instrumental in executing the development phase of our vision." Joyce continued, "As a result, we now have the opportunity to demonstrate the safety and effectiveness of our device in a clinical setting. If successful, we will provide new hope to those afflicted with Hepatitis-C and other infectious diseases."
According to the World Health Organization, Hepatitis-C (HCV) is a global disease with approximately 190 million persons infected. The infected population in India exceeds 12.5 million. In the United States, HCV is the most common blood-born infection with approximately 3.9 million citizens infected. HCV is a leading cause for liver disease and the most common reason for liver transplantation. Unfortunately, only 50% of HCV infected respond to the current standard of Interferon and Ribavirin treatment. Interferon and Ribavirin regimens are expensive and are known to have serious side effects.
Individuals enrolled in the initial trial are HCV-infected patients that require kidney dialysis as a result of End Stage Renal Disease (ESRD). Approximately 30-35% of all ESRD patients are infected with HCV, and as a result of their condition, are unable to endure the toxicity of HCV drug treatment. Follow-on studies are planned to evaluate the ability of the Hemopurifier to improve patient response rates to Interferon and Ribavirin as a conjunctive therapy, and as a stand-alone treatment for patients who are either unable to endure or do not respond to the current standard of care. The trial will also serve as a means to obtain human safety data, which will be submitted in conjunction with planned regulatory initiatives to treat the Human Immunodeficiency Virus (HIV) and drug and vaccine resistant Biological Weapons. Initial safety data and preliminary efficacy observations from the trial are expected to be available within the next sixty days.
About Aethlon Medical
Aethlon Medical is pioneering the development of immunotherapeutic devices able to mimic the immune response of clearing viruses and viral toxins from circulation. The company's lead product, the Hemopurifier(TM), converges the established principals of hemodialysis and affinity chromatography with the discovery of compounds that effectively adhere to the surface of a multiple envelope viruses. The Hemopurifier(TM) is targeted to treat acute and chronic infectious diseases, including, drug and vaccine resistant Biological Weapons, the Human Immunodeficiency Virus (HIV), and the Hepatitis-C Virus (HCV). The company has an experienced management team, which receives support and guidance from globally recognized science and regulatory advisors representing the infectious disease, biowarfare, and dialysis industries.
For more information about Hemopurifier technology, visit http://www.aethlonmedical.com or call 858/459-7800, ext. 300.
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