SAN DIEGO - October 2, 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, today released the treatment protocol underlying a program
that will provide hard-to-treat HCV-infected individuals with expanded
access to Hemopurifier® therapy. The Company also disclosed inclusion
and exclusion criteria for candidate patients as well as details on the
physicians who will administer the program, which is expected to
generate first product sales of the Aethlon Hemopurifier®.
The Aethlon Hemopurifier® is a first-in-class medical device with
broad-spectrum capability to address infectious viral pathogens and
immunosuppressive exosomes underlying cancer and other life-threatening
conditions. In the expanded access program, Hemopurifier® therapy will
be administered to selectively target the rapid clearance of HCV from
the entire circulatory system to improve benefit, dose, duration and
tolerability of standard-of-care drug therapy. The program is being
initiated with support from the Institutional Review Board at the
Medanta Medicity Institute (Medicity) to allow compassionate usage of
the Aethlon Hemopurifier® for individuals who previously failed or
subsequently relapsed standard-of-care drug regimens. The Medicity is a
leading center for medical tourism in India.
In addition to offering Hemopurifier® therapy to the citizens of
India, HCV-infected individuals from the United States, European Union
and other regions of the world may pursue treatment through the expanded
access program. It is estimated that approximately 170 million people
worldwide are infected with HCV, which leads to chronic liver disease or
cirrhosis, and is a leading cause of liver transplantation.
"We are grateful for the opportunity to provide hard-to-treat
HCV-infected individuals with access to Hemopurifier® therapy," stated
Aethlon Chairman and CEO, Jim Joyce. "Beyond advancing our therapeutic
objectives, the resulting Hemopurifier® product sales will augment the
government contract revenue stream we established this past year."
The Medicity Expanded Access Treatment Protocol
The Medicity expanded access program will offer HCV-infected
individuals the option of either a 3-day or 7-day Hemopurifier® therapy
regimen. Under each regimen, Hemopurifier® therapy will be administered
continuously for a period up to six hours on each treatment day. While
there will be a difference in cost, Hemopurifier® therapy underlying
both regimens will be initiated in combination with standard-of-care
drug therapy. The treatment objective will be to accelerate the rate and
increase the likelihood that patients achieve undetectable HCV RNA.
Details related to therapy pricing and candidate patient enrollment
processes at the Medicity are anticipated in the coming weeks.
Candidate Patient Inclusion Criteria
- Males or females 18 years of age and older testing positive for any HCV genotype
- HCV-infected individuals that have relapsed after completing a previous course of standard-of-care drug therapy
- Null responders or individuals 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
- Individuals on ACE inhibitors must suspend ACE inhibitor administration for a minimum of six days prior to initiating therapy
- Karnofsky score = 60
- Details of blood chemistry inclusion criteria will be provided to candidate patients who meet the above criteria
- Candidate patients will be required to sign a written informed consent prior to enrollment in the treatment access program
Candidate Patient 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 drug 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 immune-regulatory 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
- Any cancer requiring systemic chemotherapy
- Any other condition that, in the opinion of the principal
investigators or treating physicians, would make the subject unsuitable
for enrollment, or could interfere with the subject participating in and
completing the expanded access protocol
Current HCV Studies
In addition to the forthcoming expanded access program, Aethlon has
been conducting a study at the Medicity which is evaluating the
capability of the Aethlon Hemopurifier® to accelerate HCV RNA depletion
at the outset of standard of care peginterferon+ribavirin (PR) therapy.
Specifically, 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.
A primary clinical endpoint of the Medicity 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
only 10.35% (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.
Aethlon reported that Hemopurifier® therapy has been well tolerated
and without device-related adverse events in 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. At present, undetectable HCV RNA is
reported in eight of the 10 treated patients. Of the two patients with
detectable HCV RNA, one 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.
About Medanta – The Medicity
Medanta – The Medicity is one of India's largest multi-super
specialty institutes located in Gurgaon, a bustling town in the National
Capital Region. Founded by eminent cardiac surgeon, Dr. Naresh Trehan,
the institution has been envisioned with the aim of bringing to India
the highest standards of medical care along with clinical research,
education and training. Medanta is governed under the guiding principles
of providing medical services to patients with care, compassion and
commitment.
Spread across 43 acres, the institute includes a research center,
medical and nursing school. It has 1250 beds and over 350 critical care
beds with 45 operation theatres catering to over 20 specialties. Medanta
houses six centers of excellence, which provide medical intelligentsia,
cutting-edge technology and state-of-the-art infrastructure with a
well-integrated and comprehensive information system. The Medicity
brings together an outstanding pool of doctors, scientists and clinical
researchers to foster collaborative, multidisciplinary investigation,
inspiring new ideas and discoveries; and translating scientific advances
more swiftly into new ways of diagnosing and treating patients and
preventing diseases. A one-of-its-kind facility across the world,
Medanta through its research integrates modern and traditional forms of
medicine to provide accessible and affordable healthcare.
The Medicity Expanded Access Program Physicians
Dr. Vijay Kher - Chairman, Division of Nephrology, Kidney & Urology Institute
Dr. Vijay Kher is currently Chairman, Division of Nephrology,
Medanta Kidney & Urology Institute. Dr. Kher has established
Academic & Clinical departments of Nephrology at Shere-Kashmir,
Institute of Medical Sciences in Srinagar, SGPGIMS Lucknow, Apollo
Hospitals, New Delhi, Fortis group of hospitals NCR, Delhi & now at
Medanta. His research interests are kidney transplantation (clinical
immunosuppression, pre emptive kidney transplantation & steroid free
immunosuppression, cost-containment), progression of renal disease,
acute kidney injury and glomerulonephritis. An astute clinician, a
teacher par excellence and a keen researcher, Dr. Kher combines these
assets with a friendly and inclusive demeanor to inspire the Nephrology
fraternity in India by his professional dedication, academic excellence
and social responsibility. He has been awarded fellowships of National
Academy of Medical Sciences, Royal College of Physicians Edinburg &
Indian Society of Nephrology. Dr. Kher has published more than 150
papers in peer-reviewed journals, 24 book chapters and has edited 5
books.
Dr. Randhir Sud - Chairman, Medanta Institute of Digestive & Hepatobiliary Sciences
Dr. Sud is Chairman of The Medanta Institute of Digestive &
Hepatobiliary Sciences, which is a dedicated facility for patients with
gastrointestinal, liver, pancreatic and biliary diseases, There are
multiple treatment options for a disease and to provide the best
available treatment to patients, this Institute has devised protocols
where medical, surgical and allied teams jointly decide patient
treatments and management.
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 the Defense
Advanced Research Projects Agency (DARPA) that would reduce the
incidence of sepsis in combat-injured soldiers and civilians. 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 for the Company to derive
business partnerships or future revenue streams using the Aethlon ADAPT™
system including the ability to introduce a targeted breast cancer
therapy known as HER2osome™, there is no assurance that FDA will approve
the initiation of the company's clinical programs or provide market
clearance of the company's products, the ability to achieve the goals
set out in the DARPA contract, future human studies of the Aethlon
Hemopurifier® as an adjunct therapy to improve patient responsiveness to
established cancer therapies, 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.
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
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