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.
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
Individuals interested in the study are encouraged to contact:
Dr Puneet Sodhi
Mail ID:
puneet.sodhi@Medanta.orgContact No.: +91-9910002681
Jitendra Kumar Gupta
Mail ID:
jitendra@qualtran.comContact No.: +91-9313365371
Information requests can also be sent directly to Aethlon Medical at:
info@aethlonmedical.com
Current HCV Studies
Aethlon has previously reported data from a clinical program at the
Medicity that is evaluating the capability of the Aethlon Hemopurifier�
to accelerate HCV RNA depletion at the outset of standard of care
peginterferon+ribavirin (PR) therapy. In this study, HCV-infected
individuals are enrolled to receive up to three, six-hour Hemopurifier�
treatments during the first three days of PR drug therapy. Aethlon
recently reported that two HCV-infected patients who received
Hemopurifier� therapy in combination with PR drug therapy achieved
undetectable viral load at day-7, which is rarely reported in drug
therapy alone.
The primary clinical endpoint of this study protocol has been to
increase the incidence of rapid virologic response (RVR), defined as
undetectable HCV RNA at day 30 of therapy. RVR represents the clinical
endpoint that best predicts treatment cure, otherwise known as sustained
virologic response (SVR), defined as undetectable HCV RNA 24-weeks
after the completion of PR drug therapy. As a point of reference, the
landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that
only10.35% (n=318/3070) of PR treated patients achieved a RVR. However,
patients that achieved a RVR had SVR rates of 86.2% (n=274/318) versus
SVR rates of 32.5% (n=897/2752) in non-RVR patients. While the
incidence of undetectable HCV RNA at day-7 is not reported in the IDEAL
study, the study did reveal that just 4.3% (n=131/3070) of patients
achieved undetectable HCV RNA at day-14, which equated to a 91%
(n=118/131) SVR rate.
To date, Aethlon has reported that Hemopurifier� therapy has been
well tolerated and without device-related adverse events in the first
ten treated patients. Of these ten patients, seven patients were
infected with HCV genotype-1; two patients were infected with HCV
genotype-3; and one patient was infected with HCV genotype-5. Aethlon
previously reported undetectable HCV RNA in eight of the 10 treated
patients. Of the two patients reported to have detectable HCV RNA, one
had discontinued PR therapy as a result of a diabetes related condition.
HCV RNA is undetectable in all patients (n=4) that have been monitored
for 48 weeks since receiving Hemopurifier� therapy. Among the 10
treated patients, Aethlon reported that six genotype-1 patients received
the three treatment Hemopurifier� protocol, which resulted in four
(67%) patients achieving a RVR. The IDEAL study predicts it would
normally require approximately 40 PR treated patients to achieve 4 RVR
outcomes. Both patients who achieved undetectable HCV RNA at day-7 also
achieved a RVR. Beyond the high likelihood of a SVR, genotype-1
patients that achieve a RVR also have the opportunity to reduce the
duration of PR drug therapy from 48 weeks to 24 weeks.
Aethlon expects to report updated results, including new patient
data from this study in the near future. The Company also disclosed it
is presently incorporating new patient data within investigational
device exemption (IDE) that is expected to be submitted to FDA by
year-end in an effort to gain approval to initiate HCV clinical programs
in the United States.
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
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com Newswire
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