Aethlon Medical Announces Expansion of Compassionate-Use Program To Treat Hepatitis C Virus (HCV)

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Aethlon Medical Announces Expansion of Compassionate-Use Program To Treat Hepatitis C Virus (HCV)

SAN DIEGO, Dec. 12, 2012 /PRNewswire/ -- 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.

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.

The Treatment Protocol

The Medicity is offering compassionate-use access to Hemopurifier® therapy on a minimum three-day treatment regimen with the option for patients to extend treatment to a maximum period of seven consecutive days.  During each treatment day, Hemopurifier® therapy is administered for a duration of up to six-hours. In HCV-infected individuals who previously failed or subsequently relapsed drug therapy, the goal of Hemopurifier® therapy is to accelerate the early viral kinetic response to drug therapy without adding drug toxicity or interaction risks.  More specifically, Hemopurifier® therapy targets to increase immediate and rapid virologic response rates, which correlate with high clinical cure rates.  In viral breakthrough patients, the goal of Hemopurifier® therapy is to reset viral load to undetectable levels as a strategy to salvage the continuance and benefit of drug therapy.

Medicity is offering the three-day treatment regimen at $7,235.00 (USD), which includes Hemopurifier® therapy, physician and support fees, hospital lodging, catheter and other consumables.  The cost for each treatment day beyond the minimum three-day regimen is $2,295.00.  Pre-treatment consult and post treatment monitoring is charged at $200/day and includes transportation to and from hotel.

The Medicity has established the following inclusion and exclusion criteria for candidate patient consideration:

Inclusion Criteria

    Males or females 18 years of age and older testing positive for any HCV genotype
    Patients who initially responded to standard-of-care drug therapy, but have since suffered a virologic breakthrough
    Patients who relapsed after completing a previous course of standard-of-care drug therapy
    Null responders or patients who previously were unable to achieve > 2 log viral load reduction at month three of standard of care drug therapy
    Candidate patients must be willing to submit to temporary vascular access catheterization
    Ability to tolerate blood volume losses of up to 150 ml per week
    Stable clinical condition, including stable hematocrit
    Patients on ACE inhibitors must suspend ACE inhibitor administration for a minimum of six days prior to initiating therapy.
    Karnofsky score ≥ 60
    A more detailed list of inclusion criteria, including blood chemistry requirements will be provided to candidate patients who meet the above criteria
    The subject must be informed of the investigational nature of this study and written informed consent obtained prior to enrollment in this study

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