Aethlon Medical, Inc., a company creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions, has announced that the European Patent Office has provided the company with a decision to grant a patent entitled "Method of removal of viruses from blood by lectin affinity hemodialysis". The European Patent will be assigned Patent No. 1624784 and has been referenced in European Patent Office Bulletin No. 13/29.
The registration of the patent expands the protection of the Aethlon Hemopurifier and includes designations in the United Kingdom, Germany, Ireland, Italy, France, and Belgium. The Hemopurifier is a first-in-class medical device that targets the rapid elimination infectious viral pathogens from blood.
Previously, the United States Patent and Trademark Office (USPTO) issued Patent No. 7,226,429 to Aethlon Medical on June 5, 2007. Patent No. 7,226,429 was also entitled: "Method of removal of viruses from blood by lectin affinity hemodialysis". On October 16, 2012, the USPTO issued Aethlon Patent No. 8,288,172, which was entitled: "Extracorporeal removal of microvesicular particles". Patent No. 8,288,172 protects the use of the Aethlon Hemopurifier as a method to remove immunosuppressive exosomes from blood.
Last month, Aethlon disclosed that the United States Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier in the United States. Under the feasibility study protocol, Aethlon will enroll ten end stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease conditions.
Specific to the treatment of HCV, the Hemopurifier is uniquely positioned as an adjuvant to be incorporated with 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 a candidate solution for viral rebound patients who traditionally are forced to discontinue therapy at the point HCV establishes resistance to drug regimens. Additionally, the Hemopurifier addresses the large population of HCV-infected ESRD patients for which SOC and emerging all-antiviral strategies may be contraindicated or not yet cleared.
The FDA approved Hemopurifier therapy feasibility study calls for a single-site enrollment of ten HCV-infected end-stage renal disease (ESRD) patients who have not received any pharmaceutical therapy for their HCV infection for at least 30 days. The protocol consists of a control phase which consists of three consecutive standard dialysis treatments during week one followed by the inclusion of the Hemopurifier during a total of six dialysis sessions conducted during weeks two and three. The rate of adverse events observed during the Hemopurifier therapy phase will be compared to the rate experienced during the control phase. Per-treatment changes of viral load will be observed through quantitative PCR analysis. Additionally, Aethlon may also choose to quantitate HCV viral copies captured within the Hemopurifier during each treatment session.
In studies previously conducted in India, Hemopurifier therapy was demonstrated to be well tolerated in treatment 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 standard of care (SOC) resulted in undetectable HCV in as little as seven days in hardest to treat genotype-1 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 feasibility study protocol was originally designed as a human safety challenge and model for addressing drug and vaccine resistant bioterror and emerging pandemic threats. In vitro studies conducted by leading government and non-government researchers have demonstrated that the Hemopurifier is able to capture a broad-spectrum of some of world's deadliest viral pathogens. These include: Dengue hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF), Lassa hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), H1N1 swine flu virus, the reconstructed 1918 influenza virus (r1918), West Nile virus (WNV) and Vaccinia and Monkeypox (MPV), which serve as models for human smallpox infection. Human efficacy studies are not permissible against high-threat bioterror and pandemic threats.
The Hemopurifier is also being tested for its ability to capture glycopathogen targets that initiate or enhance the progression of sepsis through a contract with the Defense Advanced Research Projects Agency (DARPA). Sepsis is a life-threatening illness triggered by an overwhelming infection of the bloodstream.
In cancer, the Hemopurifier has been discovered to capture tumor-derived exosomes underlying several forms of cancer. Tumor-derived exosomes have recently emerged to be a vital therapeutic target in cancer care. These microvesicular particles suppress the immune response in cancer patients through apoptosis of immune cells and their quantity in circulation correlates directly with disease progression. Beyond possessing immunosuppressive properties, tumor-derived exosomes facilitate tumor growth, metastasis, and the development of drug resistance. By addressing this unmet medical need, the Hemopurifier is positioned as an adjunct to improve established cancer treatment regimens. In vitro studies to date have also documented that the Hemopurifier captures exosomes underlying lymphoma, melanoma, ovarian, and breast cancer.
In design, the Aethlon Hemopurifier consists of the affinity lectin Galanthus nivalis agglutinin (GNA) immobilized in the outer-capillary space of advanced plasma membrane technology. The design allows for extracorporeal therapeutic delivery to occur on standard CRRT and dialysis instruments already located in hospitals and clinics worldwide. The mechanism of the Hemopurifier to rapidly eliminate a broad-spectrum disease targets is based on GNA's ability to selectively bind unique high mannose signatures that are abundant on the surface of cancer-secreted exosomes and glycoproteins that reside on the outer membrane of infectious viral pathogens.