Aethlon Medical, the pioneer in developing targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions, has entered into an agreement with Qualtran, LLC that would expand human clinical studies of Hemopurifier therapy to include individuals infected with dengue virus, a global health threat, which is not addressed with approved drug or vaccine therapies. Aethlon is also in the process of initiating the first FDA approved study of Hemopurifier therapy in individuals infected with hepatitis C virus (HCV).
The Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumour-secreted exosomes that promote cancer progression. Aethlon disclosed that it will incorporate data from the proposed dengue treatment study into a Humanitarian Use Device (HUD) submission, which provides an alternative FDA pathway for obtaining market approval for medical devices that address disease conditions that affect fewer than 4,000 individuals in the US per year. Dengue also represents a disease condition where efficacy treatment studies in the US are not feasible.
The treatment of dengue virus represents a significant unmet need and serious global health challenge. At present, there is no approved cure or vaccination against dengue virus, which can develop into a lethal complication known as dengue hemorrhagic fever. The disease infects some 100 million people each year, according to the World Health Organization (WHO), and some experts put the number at three times that level. The number of dengue cases has been increasing worldwide in part because of urbanisation and in part due to the ability of the mosquito that carries the disease to adapt for survival in more temperate zones.
Qualtran is a contract research organization that previously originated and managed clinical studies of Hemopurifier therapy in HIV and HCV infected individuals at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity Institute, all located in India. On behalf of Aethlon Medical, Qualtran also established a collaborative relationship with the National Institute of Virology (NIV) that demonstrated the utility of the Hemopurifier to capture dengue virus. The NIV is the government of India's primary infectious disease research institute and is also designated as a collaborating WHO laboratory. As part of the dengue treatment agreement, Qualtran has agreed to establish multiple treatment sites and recruit thought leaders from the dengue field to establish consensus treatment protocols in advance of the 2015 dengue outbreak season.
On September 2, 2014, Aethlon disclosed that it had received internal review board (IRB) approval to initiate US clinical studies of Hemopurifier therapy based on an Investigational Device Exemption (IDE) that was cleared by the United States Food and Drug Administration (US FDA). The company is now preparing to launch the IDE approved feasibility study, which will contribute safety data to advance the Hemopurifier as a broad-spectrum countermeasure against chronic viral pathogens such as HIV and HCV, and high-risk bioterror or pandemic threats such as dengue and ebola virus.
In this regard, the Company has indicated that it would seek opportunities to expand its treatment indications through HUD and Emergency Use Authorization (EUA) pathways based on previous human treatment outcomes and pre-clinical validations against a broad-spectrum of viral pathogens. In vitro studies of bioterror and pandemic threats have verified Hemopurifier capture of ebola hemorrhagic virus, dengue hemorrhagic virus, lassa hemorrhagic virus, H5N1 avian influenza (bird flu), the reconstructed 1918 influenza virus (r1918), 2009 H1N1 influenza virus (swine flu), West Nile virus, and monkeypox, which serves as a model for human smallpox infection. These studies were conducted with leading government and non- government research organizations, including The US Army Medical Research Institute of Infectious Diseases (USAMRIID), The Centers for Disease Control and Prevention (CDC), The National Institute of Virology (NIV), The Battelle Biomedical Research Center (BBRC) and The Southwest Foundation for Biomedical Research (SFBR).