Aethlon Medical Announces Approval of Hepatitis C Virus (HCV) Treatment Program
SAN DIEGO, Aug. 26 /PRNewswire-FirstCall/ — Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that the Medanta Independent Ethics Committee (MIEC) at Medanta, The Medicity Institute (Medicity) has approved a treatment program entitled: “Use of the Aethlon HemopurifierÃ‚® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy.” The Medicity 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 HemopurifierÃ‚® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the HemopurifierÃ‚® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates.
“We are grateful for this opportunity to show the pharmaceutical industry, infected patients, and shareholders that our HemopurifierÃ‚® can enhance the capabilities of drug regimens without adding additional drug toxicity and interaction risks”, stated Aethlon Chairman and CEO, Jim Joyce. “Beneficial outcomes will set the stage for the early commercialization of our technology and should recalibrate industry viewpoints on addressing infectious disease conditions.”
Upon the demonstration of early treatment benefit, Aethlon plans to advance commercialization through the Medicity and other regional treatment centers in India. In this regard, the company has entered into an agreement with GVK Biosciences (GVK BIO) to expand the opportunity for Aethlon to commercialize its HemopurifierÃ‚® 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 greater than 20 million of the estimated 180 million people infected with HCV worldwide reside in India. Based on patient feedback, Aethlon also believes that citizens of other nations may chose to travel to India to seek treatments that could resolve their HCV infection.
Aethlon further disclosed that the principal investigator of the clinical program, 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 HemopurifierÃ‚® human studies to treat HCV at the Apollo and Fortis Hospital in Delhi, India. These studies demonstrated safety and effectiveness of the HemopurifierÃ‚® to reduce viral load in the absence of drug therapy. Patients enrolled in the Medicity study will receive a maximum of six HemopurifierÃ‚® treatments within the first week of initiating SOC drug therapy. In addition to monitoring for improved acceleration of viral load reduction at the outset of SOC, another primary endpoint will focus on rapid viralogic response (RVR) which is defined as undetectable viral load 30 days after SOC initiation. On average, approximately 15% of patients who initiate SOC therapy achieve a RVR. Yet, those able to achieve a RVR have a greater than 88% likelihood of achieving a sustained viralogic response. The initiation of patient enrollment for the Medicity is conditional upon maintaining the treatment protocols approved by the MIEC and that clinical endpoint / efficacy assessment be further clarified by the principal investigator. Aethlon has also agreed to give consideration to compensating enrolled patients for lost wages while receiving HemopurifierÃ‚® treatment and other consideration should a material adverse event occur as a result of HemopurifierÃ‚® therapy.
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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 HemopurifierÃ‚® 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 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.
Contacts: James A. Joyce Chairman, CEO 858.459.7800 x301 firstname.lastname@example.org John P. Salvador Director, Communications & Investor Relations 858.459.7800 x307 email@example.com Jon Cunningham RedChip Companies, Inc. 800.733.2447 x107 firstname.lastname@example.org
SOURCE Aethlon Medical, Inc.