Filtering infectious pathogens and cancer cells directly from whole blood has been an almost fantastic proposition, but the Hemopurifier from Aethlon Medical does just that. We’ve been covering it for over 10 years on Medgadget as it proves itself in clinical trials and new applications for it are discovered. It has already been studied as a treatment option for hepatitis C, metastatic melanoma, and the Ebola virus. Recently at the 2017 BIO International Convention in San Diego, virus capture data was presented from a study of the Hemopurifier involving health-compromised patients infected with a virus.
We were offered and took an opportunity to ask James A. Joyce, Chairman and CEO of Aethlon Medical, about the technology within the Hemopurifier, its place in clinical care, and the future potential of the company.
Medgadget: Can you summarize for us how the Hemopurifier works and how the technology originated?
James A. Joyce: The Hemopurifier is a single-use disposable cartridge that we designed for use within the established infrastructure of dialysis machines and other blood circulatory instruments already located in hospitals and clinical worldwide.
From mechanism of action standpoint, the Hemopurifier converges the use of biocompatible plasma membrane technology with a plant-derived lectin known as galanthus nivalis agglutinin (GNA), which has an affinity to bind a broad-spectrum of infectious viruses, yet has limited interactions with human proteins that are essential for health. In essence, we capture infectious viruses by their surface glycan shield, which is an evolutionary structure that viruses deploy to cloak themselves from being recognized by the host immune system. As a result, we are able to eliminate circulating infectious viruses before they are able to infect new cells or organs. For average size person, the entire circulatory system can pass through the Hemopurifier about once every 20 minutes.
Medgadget: What is the experience for the patient like? Is it much like hemodialysis? How long does a treatment session last?
James A. Joyce: To date, Hemopurifier therapy has been administered to virally infected individuals for periods of four to six and one-half hours. Unless patient is extremely ill, they are able to read or watch TV during which treatment is being administered and do so in a relaxed environment.
Medgadget: Although primarily intended to capture viruses, it has been studied for preventing the spread of metastatic melanoma. What is the status of that and do you expect the device to be applicable to other cancers?
James A. Joyce: We are quite proud of our cancer research as more than a decade ago, we began patenting our belief that tumor-derived exosomes played a significant role in cancer progression and much like infectious viruses, these targets had an immune-evasion surface structure similar to viruses that would allow us to capture them with our Hemopurifier. At the time however, the consensus of the mainstream medical community consensus was that exosomes were nothing more that cellular debris and had no biological function.
As it turns out, our original belief was right! Tumor-derived exosomes represent a significant unmet need in cancer care as they subvert the immune system of cancer patients and seed the creation and spread of metastasis, which is attributed to 90% of cancer deaths. We have demonstrated that the affinity mechanism by which the Hemopurifier operates can capture tumor-derived exosomes associated with several forms of cancer, including breast, ovarian and metastatic melanoma. Additionally, as a medical device, we believe the Hemopurifier can combine to augment the benefit of other cancer therapies without adding drug toxicity or interaction risks.
Medgadget: What about Ebola? Has the device been used on enough patients to determine its effectiveness?
James A. Joyce: The Hemopurifier was used in the successful treatment of a critically-ill Ebola-infected patient in Frankfurt, Germany.
At the Frankfurt University Hospital, a Ugandan physician, who was infected with Ebola in Sierra Leone where he was treating Ebola patients, was administered Hemopurifier therapy 12 days after being diagnosed. At the time Hemopurifier therapy was initiated, the patient was comatose with multiple organ failure.
The patient’s viral load prior to the administration of a single 6.5-hour Hemopurifier treatment was reported to be 400,000 virus copies per milliliter of blood (copies/ml). Post-treatment viral load was measured at 1,000 copies/ml and never again rose above that level. The treatment was well tolerated with no adverse events reported. After completion of therapy, researchers at Phillips University in Marburg Germany were able to administer what is known as the Hemopurifier capture assay, which revealed that 242 million Ebola viruses were permanently captured by the Hemopurifier during treatment. We achieved our mission to save lives, as the patient made a full recovery and was able to return home to his wife and children.
In regard to clinical study effectiveness, there is seldom the ability to demonstrate statistically significant effectiveness with Ebola and other virulent pathogens that don’t permit for controlled human clinical studies to be conducted.
Medgadget: Is Aethlon working on improving the device? Would it be appropriate to make different versions of the Hemopurifier that are indicated for different diseases?
James A. Joyce: Based on our proven broad-spectrum capabilities against viral pathogens, the current iteration of our Hemopurifier provides us many therapeutic “shots on goal”; especially when considering that only 9 of the approximately 300 viruses that are infectious to man are addressed with an approved antiviral drug. Additionally, our Hemopurifier provides an actual strategy to address previously unknown pathogens that emerge naturally through mother-nature or are created by man as agents of bioterrorism. If we wanted to accelerate the rate of eliminating a life-threatening virus from circulation, we would likely consider the simultaneous administration of two Hemopurifiers.
In regard to other disease conditions, we have the ability to interchange the immobilized GNA within the Hemopurifier with an antibody or affinity molecule that is directed toward other disease conditions. However, our focus today is to clinically advance our Hemopurifier as a broad-spectrum virus treatment countermeasure.
Medgadget: What disease targets are you looking to try the Hemopurifier on in the future?
James A. Joyce: Beyond our opportunity in infectious disease, we would like to initiate human studies of our device in those afflicted with cancer.
Medgadget: What about the future of your company? Can you share your goals and your intended direction?
James A. Joyce: We are working to establish the industry for affinity therapeutic devices to address unmet needs in global health, with an emphasis directed toward life-threatening conditions that are beyond the reach of traditional drug mechanism. Our primary mission is simply to save lives.