SAN DIEGO - December 12, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that a compassionate-use clinical program that provides HCV-infected individuals with access to the Hemopurifier� therapy, has been expanded to include individuals who experience a viral breakthrough during standard-of-care drug therapy.

 

Investorideas.com Newswire

The Aethlon Hemopurifier� is a first-in-class medical device that selectively targets the rapid clearance of HCV from the entire circulatory system to improve benefit, dosing, duration and tolerability of drug therapies. A virologic breakthrough occurs when infected individuals achieve undetectable HCV levels after drug therapy initiation, but then experience a rebound in HCV levels prior to completion of therapy. Researchers often attribute viral breakthroughs to the development of drug resistance or the emergence of HCV subtypes that are less sensitive to drug therapy.

"It is immensely disheartening when HCV-infected individuals initially respond but are then forced to discontinue their drug therapy as the result of a viral breakthrough," stated Aethlon Chairman and CEO, Jim Joyce. "Whether it be interferon-based or future all-antiviral drug strategies, there is an enduring opportunity for our Hemopurifier� to help individuals salvage benefit from their HCV drug regimen."

Aethlon previously disclosed that the compassionate-use program, which was approved by the Institutional Review Board at the Medanta Medicity Institute (Medicity), would allow individuals who previously failed or subsequently relapsed standard-of-care drug regimens with treatment access to the Aethlon Hemopurifier�. Individuals who fail drug therapy maintain detectable HCV levels throughout the course of drug therapy, whereas a treatment relapse is defined when HCV levels decrease and remain undetectable during treatment, but become detectable after cessation of therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. Additional details about the Medicity can be found online at www.medanta.org. Under the compassionate-use program, the Medicity is offering Hemopurifier� therapy to HCV-infected individuals that reside in India or travel from other regions and meet the inclusion/exclusion criteria that have been established for participation.

Exclusion Criteria

    Clinically significant infection, other than HCV, defined as any acute viral, bacterial, or fungal infection, which requires specific therapy (Anti-infectious therapy must have been completed at least 14-days before entry into study).

    Co -infections with Hepatitis B virus and Human immunodeficiency virus ( HIV )

    Received any investigational agent(s) within 28-days of entry into study

    Any known pre-existing medical condition that could interfere with the subject's participation in the protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly controlled diabetes mellitus, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypotension, or significant arrhythmia)

    Subjects with ECG showing clinically significant abnormalities

    Need for frequent blood transfusions.

    Recent History of bleeding or bleeding disorders requiring the restriction in use of anticoagulants during study treatments.

    Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis).

    Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immunoregulatory medications

    Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months. Subjects receiving methadone within the past year are also excluded.)

    Any cancer requiring systemic chemotherapy

    Any other condition that, in the opinion of the Principal Investigators, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol

Individuals interested in the study are encouraged to contact:

Dr Puneet Sodhi

Mail ID: This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact No.: +91-9910002681

Jitendra Kumar Gupta

Mail ID: This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact No.: +91-9313365371

Information requests can also be sent directly to Aethlon Medical at: This email address is being protected from spambots. You need JavaScript enabled to view it.

About Aethlon Medical

The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.

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 company can successfully protect its intellectual property, that removal of exosomes from the human body will impact or lead to successful treatment of cancer, or that exosomes are the cause of tumor growth and progression, 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, 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, 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.

Contacts:

James A. Joyce

Chairman and CEO

858.459.7800 x301

This email address is being protected from spambots. You need JavaScript enabled to view it.

Jim Frakes

Chief Financial Officer

858.459.7800 x300

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Marc Robins

877.276.2467

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Published at Investorideas.com Newswire

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