Aethlon Medical Clarifies News Report
SAN DIEGO, April 20, 2011 /PRNewswire/ — Earlier today, Aethlon Medical, Inc. (OTCBB: AEMD) disclosed that it was the subject of an ABC affiliate station news story that included discussion of the company’s proposed strategy to reduce the occurrence of sepsis in wounded military personnel. As previously disclosed, the company submitted a contract response on April 1, 2011 to a Broad Agency Announcement (BAA) entitled Dialysis Like Therapeutics (DLT). In the submission, company proposed multiple capabilities including the development of dialysis-like therapy that would address the objectives of the DLT program. The company wishes to clarify that there is no assurance it will be invited to participate in the DLT program and that battlefield deployment of such a device is not feasible in the near future as suggested in the ABC affiliate news story. However, the company does believe that successful clinical outcomes in treating Hepatitis-C (HCV) infected patients with its HemopurifierÃ‚® technology does offer the potential for an early commercialization pathway of its HemopurifierÃ‚® in India. The company appreciates the coverage by the ABC news affiliate which unfortunately confused the potential commercialization timeline of our HemopurifierÃ‚® with the device proposed to be developed in our DLT response.
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, including obtaining government grants, 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 HemopurifierÃ‚® to improve the efficacy of SOC therapy against HCV, the Company’s ability to manufacture its products either internally or through outside companies and to create future generations of the HemopurifierÃ‚®, 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.
James A. Joyce
Chief Financial Officer
John P. Salvador
Director, Communications & Investor Relations
SOURCE Aethlon Medical, Inc.