About HER2osome™
HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. HER2osome™ is a novel medical device, whose goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer. Research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin® (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to fill an unmet medical need and enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks.
About the Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), hepatitis C virus (HCV) and numerous bioterror and pandemic threats. Human studies have demonstrated the Hemopurifier® to be safe and provide average viral load reductions of greater than 50% during four-hour treatment periods in both HCV and HIV infected individuals without the administration of antiviral drugs. The device is currently the subject of a human clinical study in India to evaluate its ability to accelerate viral load depletion when utilized in combination with HCV standard of care drug therapy. An investigational device exemption (IDE) to initiate clinical studies in the United States is pending with The Food and Drug Administration (FDA).
In vitro studies have also documented that the Hemopurifier® captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer. Aethlon recently expanded its exosome research programs through a collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa Monica, California. The SOC collaboration is studying the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma.
To support the advancement of its therapeutic candidates, Aethlon has developed a diagnostic assay known as ELLSA™ that is able to identify and quantify the presence of exosomes in blood and other fluids. Aethlon plans to license or sell this technology to an organization already established in the research diagnostics field.
The Aethlon Hemopurifier® and HER2osome™ were both developed from the Aethlon ADAPT™ system, an adaptive dialysis-like affinity platform technology that provides the foundation for a new class of therapeutics that selectively target the clearance of harmful agents from the entire circulatory system without the loss of essential blood components. Therapies that evolve from the Aethlon ADAPT™ system overcome the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, the device platform allows the immobilization of single or multiple affinity drug agents in the outer-capillary space of plasma membrane technology as a means to provide rapid real-time clearance of corresponding targets without adding drug toxicity or interaction risks to established therapies. Beyond providing a novel regulatory and commercialization pathway for affinity drug agents, Aethlon ADAPT™ therapies can be implemented for use within the global infrastructure of dialysis machines and CRRT systems already located in hospitals and clinics. As Aethlon advances its current pipeline of therapies toward market, the company will market the ADAPT™ system to government agencies and organizations representing the pharmaceutical, biotechnology and medical device industry. On September 30, 2011, Aethlon was awarded a $6.8 million contract from the Defense Advanced Research Projects Agency (DARPA) to develop a therapeutic device from the ADAPT™ system that would reduce the incidence of sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers.
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. For more information, please visit 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 ability to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier's® ability to capture exosomes and the impact it 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 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
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
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