Aethlon Medical, a California-based innovative medical devices company, announced that it has received approval from Institutional Ethics Committee (IEC) of India for human treatment study entitled: 'A Clinical Safety Study of the Aethlon Hemopurifier in Patients with Dengue Virus Infection', at the MAX Super Specialty Hospital in Delhi.
The Aethlon Hemopurifier is a leading broad-spectrum treatment countermeasure against viral pathogens that are untreatable with or resistant to antiviral drug therapies.
Dengue infects about 390 million people a year world-wide, 96 million of whom require treatment, according to the World Health Organization. About 12,500 people die from dengue every year. Initiation of the Aethlon Dengue study is expected this summer, pending final documentation and clearance from the Drug Controller General of India (DCGI). In 2015, the Dengue outbreak in the Delhi region was considered the worst in 20 years.
Aethlon also disclosed that in vitro studies conducted by the National Institute of Virology (NIV) have validated the rapid capture of Chikungunya virus by small-scale versions of the Aethlon Hemopurifier. The NIV is a leading infectious disease research center in India, and is designated as a collaborating laboratory of the World Health Organization.
Like Dengue, Chikungunya has emerged to become a global threat that remains unaddressed with proven antiviral drug therapies. Both viruses are transmitted by the Aedes aegypti mosquito, which also transmits Zika, a virus that was declared a global health threat by the WHO on February 1st, 2016. Zika is the most recent of four significant arboviruses that have spread to the Western Hemisphere. It follows Dengue, which first emerged aggressively in the 1990s; West Nile virus, which emerged in 1999; and Chikungunya, which emerged in 2013. 'Arbovirus' is a descriptive term applied to hundreds of predominantly RNA viruses that are transmitted by arthropods, notably mosquitoes and ticks. To date, Aethlon's in vitro capture validations of arthropod-borne viruses include: Chikungunya, Dengue and West Nile Virus.
Aethlon Medical also announced that it completed training its new principal investigator, Dr. Ronald Ralph, and additionally trained two sub-principal investigators at its FDA approved feasibility study being conducted at DaVita Med Center Dialysis in Houston, Texas. As a result, continued patient enrollment of the 10-patient study is underway. In the United States, the study supports the advancement of Hemopurifier therapy as a broad-spectrum countermeasure against bioterror and pandemic threat viruses. Upon successful completion, the study also provides a potential pathway into pivotal studies of chronic or latent viral pathogens where it is feasible to conduct controlled efficacy studies.