Aethlon Medical (NASDAQ:AEMD) is focused on developing and exploring bio-filtration devices to treat life-threatening diseases. The company’s leading therapeutic candidate is the Aethlon Hemopurifier®, which is designed as a device that targets the rapid elimination of infectious viruses and cancer by promoting exosomes from the circulatory system of patients. On March 31, 2016 Aethlon reported that the recently appointed principal investigator of its FDA approved clinical study in Houston, Texas, has completed a six-treatment protocol of Hemopurifier therapy in an enrolled patient and has consented the enrollment of the next patient.
The Hemopurifier, as Aethlon describes it, is an external filtration device which works by affinity purification (or affinity chromatography). The device is intendent to be used with a hemodialysis system. To understand how the device works, it is important to know how it is built. The Hemopurifier has cartridges with porous membranes that filter blood. The cartridge membranes can be covered with various types of substances that target molecules. Vitro studies have shown that the device is capable of capturing exosomes of various types of cancer.
The Hemopurifier is meant to be a multi functioning device, and Aethlon clearly wants it to be a treatment for many life-threatening diseases. In 2014 the Hemopurifier proved to be effective. A Ugandan man suffering from Ebola virus was hospitalized in Germany and the patient was administered hemotherapy treatment for more than six hours and had no adverse effects, until he was treated with Aethlon’s biofiltration device.
The doctors involved in the treatment measured data points to track the patient’s progress fighting the Ebola virus. According to a report by the company, before treatment, the viral load was measured at 400,000 copies per milliliter for the Ebola virus. At the end of treatment physicians measured a reduction to only 1,000 copies per milliliter for Ebola. Later the patient was free of the virus.
After the report was examined, the Federal Drug Administration has approved an investigational device exemption on January 2015 by clinical trials of Aethlon Medical's Hemopurifier device for Ebola patients. The patients will be treated with the help of the device for between six and eight hours with the purpose of reducing the Ebola virus count to less than 1,000 copies per milliliter. The FDA has allowed the use of the device on up to 20 Ebola patients.
According to a press release from the company, "The treatment was well tolerated with no adverse events reported. At the time of treatment, the Ebola patient was unconscious and suffering from multiple organ failure, which required mechanical ventilation, continuous dialysis and the administration of vasopressor medications. The patient has since made a full recovery and returned home to his family.”
Recently, Aethlon has been trying to prove that the Hemopurifier is in fact effective against a variety of viruses. On February 3rd Aethlon announced that a study entitled: "A Clinical Safety Study of the Aethlon Hemopurifier® in Patients with Dengue Virus Infection," has been approved by the Institutional Ethics Committee (IEC) at the MAX Super Specialty Hospital in Delhi, India. The trial will focus on patients with Dengue Virus Infection.
According to the World Health Organization, Dengue, while not well known in the west, infects about 390 million people a year world-wide, 96 million of them require treatment. Estimated 12,500 people die from the Virus infection. In 2015, the outbreak of Dengue was considered the worst in 20 years.
Dengue is a virus that is transmitted by the Aedes aegypti mosquito, the same type of mosquito that also transmits Zika, a recent outbreak of which showed terrified birth defects in the South America region. Both viruses currently have no cure.
Aethlon's study in the United States is a 10-patient study being conducted in a FDA approved feasibility in collaboration with DaVita (NYSE:DVA) Med Center Dialysis in Houston.
Watch our exclusive interview with Aethlon Medical CEO, James Joyce: