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Corporate Profile

About Aethlon Medical
Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device to treat infectious disease. The Hemopurifier® addresses the largest opportunity in infectious disease, the treatment of drug and vaccine resistant viruses. Regulatory and commercialization initiatives in the United States are focused on bioterror threats, while international initiatives are directed towards naturally evolving pandemic threats, and chronic infectious disease conditions including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV).

The Technology
The Hemourifier® is a novel multi-patented platform technology designed for the single use removal of viral pathogens from blood. The cartridge mimics the natural response of clearing infectious viruses and related toxins prior to cell and organ infection, and is usable with portable pumps or within the established infrastructure of dialysis machines located in hospitals in clinics. Invitro studies of the Hemopurifier® have documented efficiency in capturing a broad–spectrum of viruses, including HIV, Hepatitis-C (HCV), Dengue, Ebola, Marburg, Lassa, and Pox viruses. A recent study at the Apollo Hospital in Delhi, India documented initial safety of the Hemopurifier®, and early efficacy observations during 24-treatments administered to four heath compromised dialysis patients co-infected with HCV. The Hemopurifier® is increasingly being covered by the science and news media, with recent stories in; Popular Science, Reader Digest, The Red Herring, Genetic Engineering News, The Scientist Magazine, The National Homeland Defense Journal, CNN, NBC, ABC, the BBC.

2007 Research Initiatives
Since January 1st, Aethlon has initiated multiple collaborative efforts to explore the therapeutic potential of the Hemopurifier® with researchers at the following organizations:

• The National Institute of Virology (NIV) - The NIV is the Government of India’s leading infectious disease research center and a collaborating laboratory of the World Health Organization (WHO). This collaboration is studying the Hemopurifier® as potentially the first treatment for dengue infection and dengue hemorrhagic fever (DHF), the more severe and often fatal form of the disease. In preliminary studies, NIV researchers documented that the Hemopurifier® removes up 99.6% of live dengue virus from fluids in 30 minutes. Dengue is one of the world’s most prevalent infectious diseases with an estimated 50-100 million infections occurring each year.


• Centers for Disease Control and Prevention (CDC) - Related to the treatment of Ebola Hemorrhagic Fever (EHF), a viral condition untreatable with drug and vaccine therapy and causing death in 50-90% of infections. The CDC operates as a primary component of the Department of Health and Human Services (HHS), the principal agency in the United States government for protecting the health and safety of all Americans.


• The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) - The collaboration, which initiated in January, has expanded into a formal Cooperative Research and Development Agreement (CRADA). The focus of the agreement is to explore the therapeutic efficacy of the Aethlon Hemopurifier® against viral hemorrhagic fever (VHF) targets, including, but not limited to Ebola Virus, Marburg Virus, Lassa Virus, and Machupo Virus. USAMRIID is the lead laboratory for the U.S. Medical Biological Defense Research Program, and plays a key role in national defense and in infectious disease research.


• The Southwest Foundation for Biomedical Research (SFBR) - The collaboration is studying the Hemopurifier® as a potential treatment for Lassa Fever. Lassa Fever is classified a category “A” bioterror threat in the United States, and is a prevalent viral condition in Africa. The studies are being conducted at the nations only privately owned bio-safety level-4 (BSL-4) laboratory, located at the SFBR. BSL-4 facilities allow for the study of Lassa and other highly hazardous infectious agents requiring maximum containment.


• The University of Louisville, Dr. Douglas D. Taylor - Dr. Taylor is a recognized thought leader in the causative effects of immune suppression in cancer patients. Dr. Taylor is studying the ability of the Hemopurifier® to remove tumor secreted exosomes responsible for killing immune cells in cancer patients. The goal is to evolve the Hemopurifier® as supportive care able to reduce immune cell depletion in cancer patients.

2007 Clinical Initiatives
Aethlon is actively pursuing clinical initiatives that expand upon data collected in previous studies. In the United States, the Company is pursuing clinical programs targeting the market clearance of the Hemopurifier® as a broad–spectrum countermeasure against Category “A” bioterror threats. In India, the Company is preparing to continue with clinical programs that support the early commercialization of the Hemopurifier®.

• The United States - In March of this year, Aethlon submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA). The IDE requests permission to initiate human safety studies of the Aethlon Hemopurifier® as broad–spectrum treatment countermeasure against Category “A” bioterror threats. The demonstration of safety is a primary challenge in humans as efficacy studies of Category “A” pathogens are not possible for obvious humanitarian reasons. Category “A” threats are defined by the CDC as agents that pose a risk to national security; are easily disseminated or transmitted from person to person; result in high mortality rates; could cause public panic and social disruption, and require special action for public health preparedness. Dr. Nathan Levin, a world-renown leader in renal care, and the Director of the Renal Research Institute (RRI) in New York City has agreed to be the Principal Investigator of the clinical program proposed to the FDA. The RRI is a joint venture between Fresenius Medical Care, the global leader in the dialysis industry and Beth Israel Medical Center. Pending FDA and internal review board approval, the proposed study will occur at Beth Israel Medical Center, also based in New York City. Since the submission of Aethlon’s IDE, the Department of Health and Human Services (HHS) has mandated that broad–spectrum therapeutics become a focal point of government bioterror and pandemic treatment initiatives. As stated in the new legislation, the U.S. government will now support research, development, acquisition, storage/maintenance, deployment, and utilization of broad–spectrum treatment countermeasures able to address multiple bioterror and pandemic threats. Aethlon believes the Hemopurifier® is the most advanced broad–spectrum countermeasure for bioterror threats. A recent story in The Washington Post named Aethlon as a company most likely to benefit from the newly established Biomedical Advanced Research and Development Authority (BARDA), who is mandated to spend over $1 billion to fund countermeasure development during fiscal years 2007 and 2008. In addition, HHS will now utilize the $5.6 billion Project BioShield special reserve fund and resources of the Strategic National Stockpile to acquire, store, maintain, and deploy broad–spectrum countermeasures.


• India - Approval for a follow-on safety study of the Hemopurifer® in India has been granted by the Ethics Committee for Research at The Fortis Hospital, in New Delhi. The study will evaluate safety of the Hemopurifier® in up to ten patients with end-stage renal disease. Pending patient accrual, the study is expected to begin in August. Dr. Vijay Kher, Director of Nephrology at Fortis has agreed to be the principal investigator of the study. Previously, Dr. Kher acted as principal investigator of a Hemopurifier® study conducted at the Apollo Hospital in Delhi. The Apollo study documented initial safety of the Hemopurifier®, and provided early efficacy observations during 24-treatments administered to health compromised dialysis patients co-infected with Hepatitis-C (HCV). The Fortis study supports Aethlon’s strategy to pursue early treatment and commercialization opportunities in India. Aethlon will focus on viral conditions of greatest concern to Indian citizens, and opportunities that offer treatment access to the Hemopurifier® within India’s growing medical tourism industry. Targeted conditions may include Dengue Hemorrhagic Fever (DHF), HIV/AIDS, and HCV. At present, regulatory barriers specific to the Hemopurifier® do not exist in India. As a result, introduction of the Hemopurifier® into the marketplace will be based on obtaining sufficient clinical data to drive practitioner acceptance in the marketplace. As with previous pre-clinical and clinical programs in India, Aethlon will seek additional support and guidance from the Indian Council of Medical Research (ICMR). Aethlon may also consult with the Food and Drug Administration (FDA) on protocol design and will provide the FDA with clinical data obtained from studies as a means to potentially augment clinical efforts to advance the Hemopurifier® as a broad–spectrum countermeasure against bioterror threats in the United States.