Aethlon Medical Discloses Strategy To Commercialize Hemopurifier In India
San Diego, CA - Aethlon Medical, Inc. disclosed recently that it will pursue the commercialization of its 1st generation Hemopurifier 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 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 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 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 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 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 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 is highly efficient in capturing infectious dengue virus. In preliminary studies, the Aethlon Hemopurifier 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 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 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 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.
SOURCE: Aethlon Medical