AEMD .68 + .01 Note - this one has been proviled in Readers Digest and elsewhere and has potential in fields of cancer, AIDS, terrorism, etc.
Aethlon Medical Discloses Strategy to Commercialize Hemopurifier(R) in India
Jun 21, 2007 7:15:00 AM
Copyright Business Wire 2007
SAN DIEGO--(BUSINESS WIRE)--
Aethlon Medical, Inc. (OTCBB:AEMD) disclosed today that it will pursue the commercialization of its 1st generation Hemopurifier(R) in India during the course of the next year. The strategy to initiate commercialization in India corresponds with Aethlon's international objectives and will parallel the company's effort to advance the Hemopurifier(R) as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats in the United States. "We are going to implement strategies that offer the greatest likelihood of transitioning our science from the labs and into the marketplace," stated Aethlon Chairman & CEO, James A. Joyce. "Our plans in India will reinforce our goal to establish the industry for medical devices to treat infectious disease." The Hemopurifier(R) is a first-in-class medical device designed to mimic the natural immune response of clearing infectious viruses and related toxins from circulation. The technology is positioned to fill the void in treating drug and vaccine resistant viruses.
Aethlon's commercialization strategy in India will focus on viral conditions of greatest concern to its citizens, and opportunities to offer treatment access to the Hemopurifier(R) within India's growing medical tourism industry. Targeted conditions include Dengue Hemorrhagic Fever (DHF), HIV/AIDS, and Hepatitis-C (HCV). At present, regulatory barriers specific to the Hemopurifier(R) do not exist in India. As a result, the opportunity for Aethlon to commercialize its technology within the country will be based on obtaining clinical data sufficient to drive practitioner acceptance in the marketplace. As such, Aethlon will initiate further studies that demonstrate patient safety and support the Hemopurifier(R) as a single use device designed to remove viral pathogens from blood.
In previous initiatives in India, Aethlon demonstrated safety and early observations of efficacy in a 24-treatment study of dialysis patients co-infected with HCV. The study was performed by the Apollo Hospital in Delhi. In separate studies, the company demonstrated in-vitro that the Hemopurifier(R) rapidly clears HIV and related toxins from blood. As a result Aethlon has initiated discussions with the National AIDS Research Institute (NARI) regarding studies of HIV-infected patients. NARI is the government agency overseeing India's HIV infected population. Last year, UNAIDS, the United Nations agency, estimated that India had 5.7 million HIV cases, the largest infected population of any individual country.
Most recently, researchers at the National Institute of Virology (NIV) documented that the Hemopurifier(R) is highly efficient in capturing infectious dengue virus. In preliminary studies, the Aethlon Hemopurifier(R) removed greater than 90% of live dengue virus from fluids in 30 minutes. The NIV is the Government of India's leading infectious disease research center and a collaborating laboratory of the World Health Organization (WHO). Dengue, a considerable health threat in India, is one of the world's most prevalent infectious diseases with an estimated 50 to 100 million cases each year. As the disease is not treatable with vaccines and antiviral drugs, Aethlon will pursue clinical opportunities to evolve the Hemopurifier(R) as a treatment able to provide clinical benefit by reducing viral load in infected dengue patients.
As with previous pre-clinical and clinical programs in India, Aethlon will seek guidance from the Indian Council of Medical Research (ICMR) in forthcoming Hemopurifier(R) studies. The company may also consult with the Food and Drug Administration (FDA) on protocol design of studies and will provide the FDA with clinical data obtained from studies in India as a means to augment its clinical programs in the United States.
In conjunction with this strategy, Aethlon will seek to acquire or build infrastructure in India able to assist in establishing product distribution; managing clinical programs; and training qualified medical professionals in administering the Hemopurifier(R) treatment technology. Once established, Aethlon may utilize its infrastructure to introduce other medical products into the rapidly growing Indian marketplace. Earlier this month, Red Herring magazine reported that for the fourth quarter in a row, the biotech industry in India has grown more than 35%, passing the $2 billion revenue mark in March. Biotech industry officials expect the market to reach $5 billion in revenue by 2010, and government leaders are aiming for the industry to grow to $40 billion in revenues by 2015.
About Aethlon Medical
Aethlon Medical is the developer of the Hemopurifier(R), a first-in-class medical device to treat infectious disease. The Hemopurifier(R) is an innovative platform technology targeted to be a broad-spectrum treatment solution for drug and vaccine resistant bioweapons, naturally evolving pandemic threats, and chronic infectious disease conditions including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Collaborative studies to demonstrate utility of the Hemopurifier(R) are being conducted with researchers at the Government of India's National Institute of Virology (NIV), The Centers for Disease Control and Prevention (CDC), The United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and The Southwest Foundation for Biomedical Research (SFBR). Aethlon has previously demonstrated safety of the Hemopurifier(R) in a 24-treatment human study, and most recently submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) requesting permission to initiate human studies of the Hemopurifier(R) as a treatment countermeasure against select category "A" bioterror threats. 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; may cause public panic and social disruption, and require special action for public health preparedness. Additional information on Aethlon Medical and its Hemopurifier(R) technology can be accessed 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, Inc.
----------------------------------------------
Aethlon Medical
Inc.
Jeff Richardson
Senior Director
Communications
858-459-7800
x302
jrichardson@aethlonmedical.com
or
James A. Joyce
Chairman
CEO
858-459-7800
x301
jj@aethlonmedical.com |
