SAN DIEGO, Oct. 21 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today it has established primary clinical endpoints and clarified efficacy assessments related to a study that will evaluate the use of the Aethlon Hemopurifier® in combination with standard of care (SOC) HCV drug therapy. As a result, Aethlon will now initiate the recruitment of candidate patients and begin exporting its Hemopurifier® for clinical purposes. The study will be conducted at Medanta, The Medicity Institute (Medicity), which is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system.
A primary clinical goal of the study will be to demonstrate that the Aethlon Hemopurifier® improves the acceleration of viral load depletion when administered at the outset of SOC drug therapy. Clinical endpoints of the study will assess Early Viral Response (EVR) rates, Rapid Viral Response (RVR) rates, as well as Immediate Viral Response (IVR) rates, which are all highly predictive of a sustained viral response (SVR), which is defined as undetectable viral load six months after the completion of SOC drug therapy. As the Hemopurifier® is designed to decrease the presence of circulating HCV virus, Aethlon will also seek to quantify the amount of HCV captured within the Hemopurifier® after the first application of the device in each enrolled patient. A lower body burden of HCV at the outset of SOC also correlates with improved treatment outcomes.
Early Viral Response (EVR)
As reported in the McHutchinson, et al 2009 study of 1,019 genotype I patients who initiated 48-week standard dose SOC PegIFN-a2b therapy, 39.9% of treated patients achieved an EVR. Those patients who achieved an EVR, which represents undetectable viral load at day 90 of SOC treatment, achieved 99% SVR rates, representing an improved clinical benefit of greater than 200% as compared to patients that do not achieve an EVR. A clinical goal of the Hemopurifier® study will be to increase the established likelihood that patients achieve an EVR.
Rapid Viral Response (RVR)
Also reported in the McHutchinson, et al 2009 study of 1,019 genotype I patients who initiated 48-week standard dose SOC PegIFN-a2b therapy, only 11.4% of treated patients achieved a RVR, which is defined as undetectable viral load at day 30. However, those patients who achieved an RVR had SVR rates of approximately 90%, which represents a clinical benefit greater than 100% as compared to patients that do not achieve an RVR. An additional clinical goal of the Hemopurifier® study will be to increase the likelihood that patients achieve an RVR.
Immediate Viral Response (IVR)
Aethlon will also seek to demonstrate that the addition of the Hemopurifier® to SOC drug therapy improves Immediate Viral Response (IVR) rates as compared to patients who receive SOC alone. IVR, also known as first-phase kinetics, will be determined by measuring viral load at the end of day one (1), day two (2), day three (3), and day seven (7). In this regard, an additional clinical goal will be to demonstrate the application of the Hemopurifier® in combination with SOC improves first-phase viral depletion kinetics in enrolled patients.
The principal investigator of the clinical study, which has been registered with the Clinical Trials Registry of India, will be Vijay Kher, M.D., Chairman of the Department of Nephrology at the Medanta Kidney & Urology Institute. Dr. Kher previously served as the principal investigator of Hemopurifier® human studies to treat HCV at the Apollo and Fortis hospitals in Delhi, India. The Apollo and Fortis studies demonstrated safety and the effectiveness of the Hemopurifier® to reduce viral load in the absence of drug therapy. Patients enrolled in the Medicity study will receive a maximum of six Hemopurifier® treatments within the first week of initiating SOC drug therapy. The study will enroll up to 30 patients.
Upon the demonstration of improved clinical outcomes, Aethlon plans to advance commercialization through the Medicity and other regional treatment centers in India. The company has entered into an agreement with GVK Biosciences (GVK BIO) to expand the opportunity for Aethlon to commercialize its Hemopurifier® treatment technology at three to five new clinical centers in India. GVK BIO is Asia's leading Discovery Research and Development organization. The HCV treatment opportunity for Aethlon is significant as it is estimated that 20 million of the 180 million people infected with HCV worldwide reside in India. Based on patient feedback, Aethlon also believes that citizens of other nations that are infected with HCV may choose to travel to India to seek out new therapies that could help address their HCV infection. However, Medanta's Independent Ethics Committee (MIEC) has not yet approved the enrollment of treatment candidates who reside outside of India.
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
- Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier® to improve the efficacy of SOC therapy against HCV, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
SOURCE Aethlon Medical, Inc.