Aethlon Medical Announces Dengue Virus Treatment Agreement
SAN DIEGO, Sept. 24, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB: AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions, announced today that it has entered into an agreement with Qualtran, LLC that would expand human clinical studies of Hemopurifier® therapy to include individuals infected with dengue virus, a global health threat, which is not addressed with approved drug or vaccine therapies. Aethlon is also in the process of initiating the first FDA approved study of Hemopurifier® therapy in individuals infected with hepatitis c virus (HCV).
The Hemopurifier® is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression. Aethlon disclosed that it will incorporate data from the proposed dengue treatment study into a Humanitarian Use Device (HUD) submission, which provides an alternative FDA pathway for obtaining market approval for medical devices that address disease conditions that affect fewer than 4,000 individuals in the U.S. per year. Dengue also represents a disease condition where efficacy treatment studies in the U.S. are not feasible.
The treatment of dengue virus represents a significant unmet need and serious global health challenge. At present, there is no approved cure or vaccination against dengue virus, which can develop into a lethal complication known as dengue hemorrhagic fever. The disease infects some 100 million people each year, according to the World Health Organization (WHO), and some experts put the number at three times that level. The number of dengue cases has been increasing worldwide in part because of urbanization and in part due to the ability of the mosquito that carries the disease to adapt for survival in more temperate zones.
Qualtran is a contract research organization that previously originated and managed clinical studies of Hemopurifier therapy in HIV and HCV infected individuals at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity Institute, all located in India. On behalf of Aethlon Medical, Qualtran also established a collaborative relationship with the National Institute of Virology (NIV) that demonstrated the utility of the Hemopurifier® to capture dengue virus. The NIV is the government of India's primary infectious disease research institute and is also designated as a collaborating WHO laboratory. As part of the dengue treatment agreement, Qualtran has agreed to establish multiple treatment sites and recruit thought leaders from the dengue field to establish consensus treatment protocols in advance of the 2015 dengue outbreak season.
On September 2, 2014, Aethlon disclosed that it had received internal review board (IRB) approval to initiate U.S. clinical studies of Hemopurifier® therapy based on an Investigational Device Exemption (IDE) that was cleared by the United States Food and Drug Administration (FDA). The company is now preparing to launch the IDE approved feasibility study, which will contribute safety data to advance the Hemopurifier® as a broad-spectrum countermeasure against chronic viral pathogens such as HIV and HCV, and high-risk bioterror or pandemic threats such as dengue and ebola virus.
In this regard, the Company has indicated that it would seek opportunities to expand its treatment indications through HUD and Emergency Use Authorization (EUA) pathways based on previous human treatment outcomes and pre-clinical validations against a broad-spectrum of viral pathogens. In vitro studies of bioterror and pandemic threats have verified Hemopurifier® capture of ebola hemorrhagic virus, dengue hemorrhagic virus, lassa hemorrhagic virus, H5N1 avian influenza (bird flu), the reconstructed 1918 influenza virus (r1918), 2009 H1N1 influenza virus (swine flu), West Nile virus, and monkeypox, which serves as a model for human smallpox infection. These studies were conducted with leading government and non- government research organizations, including The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), The Centers for Disease Control and Prevention (CDC), The National Institute of Virology (NIV), The Battelle Biomedical Research Center (BBRC) and The Southwest Foundation for Biomedical Research (SFBR).
About Qualtran, LLC
Qualtran has been instrumental in conducting clinical trials in the Cardiac, Infectious Disease and COPD space. For more than a decade, Qualtran has helped companies in the west execute early and late stage clinical studies in India. The Company also advises on commercialization strategies and has worked with regulatory authorities and key opinion leaders in India's fast growing healthcare market. Qualtran has helped their clients establish relationships with a wide range of Institutions, including the DCGI (Drug Controller General of India), the ICMR (Indian Council of Medical Research), the NIV (National Institute of Virology), the Ministry of Health and many leading medical institutions.
About Aethlon Medical, Inc.
Aethlon Medical creates medical devices that target unmet therapeutic needs in infectious disease and cancer. The company's lead product is the Aethlon Hemopurifier®, a first-in-class device that selectively targets the rapid elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression. Exosome Sciences, Inc. is a majority owned subsidiary that is advancing exosome-based products to diagnose and monitor cancer, infectious disease and neurological disorders. For more information, please visit http://www.aethlonmedical.com/ and connect with the Company on Twitter, LinkedIn, Facebook and Google+.
Certain 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, that the ESI will not be able to commercialize its future products, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy or as a broad spectrum defense against viral pathogens, including dengue fever, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, 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, the ability of the Company to meet the milestones contemplated in the DARPA contract as well as the ability of DARPA to fund the Company's portion of the contract, 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. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
James A. Joyce
Chairman and CEO
Chief Financial Officer
SOURCE Aethlon Medical, Inc.
Released September 24, 2014