Image: The Aethlon Medical Hemopurifier (Photo courtesy of Aethlon Medical).
A first-in-class medical device targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation.
The Aethlon Medical Hemopurifier is based on the affinity lectin Galanthus nivalis
agglutinin (GNA), which selectively binds unique high mannose signatures—abundant on the surface of cancer-secreted exosomes and glycoproteins—that resides on the outer membrane of infectious viral pathogens. Advanced plasma membrane technology is then used to eliminate broad-spectrum disease targets rapidly, based on the GNA affinity. The design allows extracorporeal therapeutic delivery to occur on standard continuous renal replacement therapy (CRRT) and dialysis instruments already located in hospitals and clinics worldwide.
The Hemopurifier can be used in the treatment of Hepatitis C virus
(HCV) as an adjuvant to either interferon-based standard of care (SOC) or emerging all-antiviral drug regimens, without adding drug toxicity. In addition to augmenting the early viral kinetic response to SOC, the Hemopurifier is also a candidate solution for viral rebound patients who are forced to discontinue therapy at the point HCV establishes resistance to drug regimens. The Hemopurifier also addresses the large population of HCV-infected end stage renal disease (ESRD) patients for which SOC and emerging all-antiviral strategies may be contraindicated or not yet cleared.
In studies conducted in India, Hemopurifier therapy was demonstrated to be well tolerated in treatment of naïve HIV and HCV-infected ESRD patients when included during normally scheduled four-hour dialysis sessions. In these studies, average per treatment viral load reductions were observed to exceed 50% in both disease conditions. In follow-on studies of non-ESRD individuals infected with HCV, a three-treatment protocol of Hemopurifier therapy in combination with interferon-based SOC resulted in undetectable HCV in as little as seven days in hardest to treat patients. The studies also documented the ability of the Hemopurifier to capture as many as 300 billion HCV copies during a single six-hour treatment.
The Hemopurifier also captures tumor-derived exosomes possessing immunosuppressive properties that facilitate tumor growth, metastasis, and the development of drug resistance. The microvesicular particles suppress the immune response in cancer patients through apoptosis of immune cells, and their quantity in circulation correlates directly with disease progression. The Hemopurifier is used as an adjunct to established cancer treatment regimens, capturing exosomes underlying lymphoma, melanoma, ovarian, and breast cancer. The Hemopurifier is a product of Aethlon Medical (San Diego, CA, USA), and has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate human feasibility studies.
“Aethlon Medical has been laying the groundwork necessary to implement the now approved clinical trial protocol for several years,” said Rod Kenley, President of Aethlon Medical. “We are finally able to move forward with our contract research and clinical partners in finalizing all of the activities that can now take place prior to initiating treatment of the first patient. While there is still some work to be done, today the biggest hurdle has been cleared, and we are anxious to make rapid progress towards commercialization.”