Aethlon Medical Discloses Ebola Treatment Pathways in the United States
SAN DIEGO, Oct. 29, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease and cancer, disclosed today that it will provide Hemopurifier® therapy under FDA compassionate use access provisions to support potential requests by qualified physicians and institutes that may seek to treat ebola virus infection in the United States.
The Aethlon Hemopurifier® is a first-in-class bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals. At present, no antiviral therapy or vaccine has proven to be effective against Ebola virus infection in humans. According to the World Health Organization (WHO), nearly 5,000 deaths have been attributed to the current ebola virus epidemic.
Based on guidance from FDA, the treatment of ebola virus infection provides for a unique circumstance where a physician or health care provider may wish to pursue the compassionate use of Hemopurifier® therapy based on the serious nature of the disease and absence of alternative therapies. Compassionate use provisions are typically approved by FDA on an individual patient basis, but may be expanded to include a small group.
Aethlon also disclosed that it plans to submit its first ebola treatment data to the FDA as a means to support the goal of further expanding treatment access through emergency use regulatory pathways.
On October 14th, 2014, the Company announced that Hemopurifier® therapy had been administered to an ebola-infected patient at Frankfurt University Hospital in Germany. The treatment was permitted through special approval from The Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte, BfArM), an independent federal higher authority within the portfolio of the Federal Ministry of Health of Germany.
"The administration of Hemopurifier® therapy in Germany has reinforced the need to clarify defined regulatory pathways that might allow us to treat ebola infection in the United States," stated Aethlon founder and CEO, Jim Joyce. "As it relates to the patient treated in Germany, we respect patient confidentiality and will report on his response to therapy after Frankfurt University Hospital officials provide an update on his condition."
In the care of ebola-infected individuals, the Hemopurifier® targets two unmet medical needs: the rapid elimination of circulating viruses to inhibit continued progeny virus replication and the direct targeting of shed glycoproteins that overwhelm the host immune response. The device can be deployed for use within the global infrastructure of dialysis and CRRT machines already located in hospitals and clinics.
Aethlon is also preparing to initiate U.S. clinical studies of Hemopurifier® therapy based on the FDA's approval of an Investigational Device Exemption (IDE) that was previously submitted by the Company. The study will contribute safety data to advance the device as a broad-spectrum countermeasure against pandemic threats, including ebola and chronic viral pathogens such as HIV and Hepatitis C (HCV).
To date, Hemopurifier® therapy has been successfully administered in approximately one hundred treatment experiences in health compromised HIV and HCV infected individuals. These studies were conducted at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity Institute, all located in India. In vitro validation studies that demonstrated the ability of the Hemopurifier to capture Zaire and other strains of ebola virus were conducted by researchers at the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and the United States Centers for Disease Control and Prevention (CDC).
About Aethlon Medical, Inc.
Aethlon Medical creates targeted therapeutic devices to address infectious disease, cancer and neurodegenerative disorders. 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 ebola, 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, 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
(Office) 858.459.7800 x301
Chief Financial Officer
SOURCE Aethlon Medical, Inc.
Released October 29, 2014