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-- WITH PHOTO -- TO BUSINESS, HEALTH, AND MEDICAL EDITORS:
Aethlon Medical to Present Hepatitis C (HCV) Treatment Technology at
the 32nd Annual Dialysis Conference
SAN DIEGO, Feb. 7, 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 presentation of
the Aethlon Hemopurifier@ to treat Hepatitis C virus (HCV) and other
infectious disease conditions will occur at the upcoming 32nd Annual
Dialysis Conference to be held on February 26-28 at the Henry B.
Gonzalez Convention Center in San Antonio, Texas. The presentation,
which will be given by Aethlon President Rod Kenley, is scheduled to
begin at 9:20 am CST on February 28th.
(Photo: http://photos.prnewswire.com/prnh/20090325/LA88762LOGO-b)
The Hemopurifier@ is a first-in-class medical device that provides
rapid real-time clearance of circulating HCV as well as
immunosuppressive proteins shed by the virus. The goal of therapy is
to improve benefit, dose, duration and tolerability of current and
future drug therapies without introducing drug toxicity and
interaction risks. Included among the Hemopurifier@ treatment
opportunities in HCV are the estimated 300,000 infected dialysis
patients that currently live with the virus. As a result of their
health-compromised end-stage renal condition, dialysis patients are
often unable to tolerate HCV drug therapy dosing and duration,
resulting in suboptimal treatment outcomes. To optimize outcomes,
Hemopurifier@ therapy would be combined with reduced dose drug therapy
and conveniently administered during regular dialysis, which is
scheduled three times per week with each treatment lasting four
hours. In regards to the size of the overall HCV treatment
opportunity, it is estimated that approximately 4 million Americans
and 170 million people worldwide are infected with HCV, which leads to
chronic liver disease or cirrhosis, and is the leading cause of liver
transplant in the U.S.
On February 1, 2012, Aethlon reported that intermittent administration
of Hemopurifier@ therapy in just the first three days of standard of
care peginterferon+ribavirin (PR) drug therapy resulted in immediate
and rapid virologic responses in genotype-1 infected HCV patients not
on dialysis. An immediate virologic response (IVR) represents a 2-log
or 100 fold reduction of HCV RNA at day-7 of therapy and rapid
virologic response (RVR) is defined as undetectable HCV RNA at day-30
of the 48-week PR regimen. Average HCV RNA reduction during the three
day Hemopurifier@ + PR treatment window was 98.79%. In previous
studies of HCV-infected dialysis patients, average per treatment
reductions of HCV RNA exceeded 50% when Hemopurifier@ therapy was
included in series with four-hour dialysis sessions in patients not
receiving HCV drug therapy.
Aethlon also anticipates that Hemopurifier@ therapy could benefit
emerging all-antiviral drug cocktails, which face the challenge of
overcoming the rate at which viruses attain drug resistance through
rapid mutation. The development of drug-resistant strains can occur
quickly owing to the extraordinarily high rate of HCV replication. The
clearance of circulating hepatitis C virions, including mutant
strains, would inhibit the continued replication of drug-resistant
viruses and decrease the likelihood of early onset resistance to
emerging all-antiviral strategies.
The Extract-1 Study Protocol
The results reported by Aethlon on February 1st, represent interim
data from the first three patients treated with Hemopurifier@ therapy
under the Extract-1 study protocol, which was initiated in the fall of
2011. Under the Extract-1 study protocol, hard-to-treat genotype 1
HCV patients are enrolled to receive three 6-hour applications of
Hemopurifier@ therapy during the first three days of standard of care
PR therapy. On day one of the Extract-1 protocol, PR therapy is
initiated within one hour of first Hemopurifer@ therapy completion.
Hemopurifier@ therapy is then administered again once daily for the
next two days in combination with PR therapy. During the
Hemopurifier@ treatment periods, patients are free to watch movies,
read books, and perform other tasks in the comfort of a clinic
setting.
Clinical Endpoint Assessments
The aim of the Extract-1 study protocol is to assess the safety and
clinical impact of intermittent Hemopurifier@ therapy when combined
with the first three days of peginterferon+ribavirin (PR)
standard-of-care. To date, Hemopurifier@ therapy in Extract-1 treated
patients has been well tolerated and without device-related adverse
events during the Hemopurifier@ + PR treatment period. At present,
the reported data of the Extract-1 study is not statistically
significant and should be considered preliminary. Changes in HCV RNA
levels are measured with the Roche Cobas TaqMan assay, which has a
quantification limit of 15 IU per milliliter (iu/ml). In addition to
measuring changes in HCV RNA, the Extract-1 study protocol will
quantify the amount of HCV captured within Hemopurifier@ treatment
cartridges. The goal of PR treatment is to establish a sustained
virologic response (SVR), defined as undetectable HCV RNA 24 weeks
after completion of therapy. Primary clinical endpoints of the
Extract-1 study measure the impact of Hemopurifier@ therapy during the
initial phase of PR therapy. Each clinical endpoint is based on
changes in HCV RNA from baseline viral load measurements taken prior
to Hemopurifier@ + PR therapy initiation. These endpoints include:
Day Three (3): the change in HCV RNA from baseline to the end of the
Hemopurifier@ + PR treatment phase;
Day Seven (7): the change in HCV RNA 7 days from initial baseline. A
drop of HCV RNA greater than 2 logs at day 7 is known as an Immediate
Virologic Response (IVR). Based on the landmark IDEAL Study of 3,070
HCV genotype-1 patients receiving PR therapy, IVR achievement
correlates with 90+% SVR rates, yet is observed in less than 5% of
patients;
Day 30: the change in HCV RNA 30 days from initial baseline.
Undetectable HCV RNA at day 30 is known as a Rapid Virologic Response
(RVR). Based on the IDEAL Study, RVR achievement correlates with an
SVR likelihood of 86.2%, which is observed in only 10.35% of patients.
Day 3 Results
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840
IU/ml when measured on day 3, representing a 3.49 log reduction. HCV
RNA reduction during the 3-day Hemopurifier@ + PR treatment phase
accounted for 99.96% of the overall HCV RNA reduction reported at
day-30.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 31,550
IU/ml when measured on day 3, representing a 0.80 log reduction. HCV
RNA reduction during the 3-day Hemopurifier@ + PR treatment phase
accounted for 84.21% of the overall HCV RNA reduction reported at
day-30.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to
54,900 IU/ml when measured on day 3, representing a 1.38 log
reduction. HCV RNA reduction during the 3-day Hemopurifier@ + PR
treatment phase accounted for 95.90% of the overall HCV RNA reduction
reported at day-30.
Day 7 Results
On average, the treated patients achieved 2.24 log HCV RNA reduction
from baseline at day-7, which is beyond the 2 log reduction that
defines the IVR criteria achieved in less than 5% of PR treated
patients.
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 234
IU/ml when measured on day 7, representing a 4.39 log reduction.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 17,300
IU/ml when measured on day 7, representing a 1.06 log reduction.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to
24,400 IU/ml when measured on day 7, representing a 1.74 log
reduction.
Day 30 Results
Two of the three patients achieved a RVR at day 30, which is normally
achieved in only 10.35% of patients receiving PR therapy, yet
correlates with a 86.2% SVR versus a 30.4% SVR in patients who fail to
achieve a RVR. Based on the IDEAL study, it would normally require
the enrollment of approximately 20 PR treated patients to accomplish 2
RVR outcomes. It should also be noted that patient E-1.02 missed RVR
achievement by 25 iu/ml.
Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to
undetectable (<15 IU/ml) when measured on day 30, representing a 5.58
log reduction.
Patient E-1.02: Baseline HCV RNA dropped from 199,500 IU/ml to 40
IU/ml when measured on day 30, representing a 3.69 log reduction.
Patient E-1.01: Baseline HCV RNA dropped from 1,340,000 IU/ml to
undetectable (<15 IU/ml) when measured on day 30, representing a 4.95
log reduction.
Beyond high SVR rates, RVR achievement also provides HCV infected
individuals the opportunity to reduce PR duration from 48 to 24 weeks
(6-month reduction) in RVR patients that maintain undetectable HCV RNA
through week 12 of PR therapy. RVR patients are also unlikely to
discontinue PR therapy as a result of a non-virological response,
which represents the primary reason why 46% of PR therapy patients
don't complete their treatment regimen.
RVR achievement also plays a pivotal role in curbing treatment
relapse, defined as undetectable HCV RNA at PR completion that again
becomes detectable in the 24-week window after therapy completion. As
reflected in the IDEAL study, the time to first undetectable HCV RNA
correlates with the incidence of treatment relapse. Approximately 50%
of patients who achieve complete HCV suppression for the first time by
week 24 of therapy suffer from treatment relapse, while less than 10%
of RVR patients relapse from therapy.
The Extract-1 study is being conducted at Medanta, The Medicity
Institute (Medicity), a $360 million multi-specialty medical institute
recently established to be a premier center for medical tourism in
India. The principal investigator of the study is Vijay Kher, M.D.,
Chairman of the Department of Nephrology at the Medanta Kidney &
Urology Institute. Dr. Kher previously served as the principal
investigator of Hemopurifier@ therapy studies conducted at the Apollo
and Fortis hospitals in Delhi, India.
Based on the initial Extract-1 study outcomes, Aethlon will seek
permission to open up the treatment study to HCV infected individuals
who reside outside of India. The company also plans to expand its GMP
manufacturing capabilities and upon quantification of HCV capture
within Hemopurifier@ treatment cartridges, will resubmit an
Investigational Device Exemption (IDE) that will request FDA
permission to initiate treatment studies in the U.S. The Company is
also interested in collaborative clinical opportunities aimed at
determining the synergistic effects of Hemopurifier@ therapy combined
with non-interferon based drug regimens.
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 ADAPTT 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
ADAPTT product pipeline includes the Aethlon Hemopurifier@ to address
infectious disease and cancer; HER2osomeT 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 to recruit genotype-1
hepatitis C infected patients, including dialysis patients, positive
results at the conclusion of the Extract-1 study, the ability to
attain permission and to attract patients outside of India, the
company's ability to expand its GMP manufacturing capabilities, the
Company's ability to attain clinical collaborations to determine the
Hemopurifier's@ effect with non-interferon based drug regimens, 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, 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
Jim Frakes Chief Financial Officer 858.459.7800 x300
John P. Salvador Director, Communications 858.459.7800 x307
SOURCE Aethlon Medical, Inc.
-0- 02/07/2012
/Photo: http://photos.prnewswire.com/prnh/20090325/LA88762LOGO-b
PRN Photo Desk, photodesk@prnewswire.com
/Web Site: http://www.aethlonmedical.com
(OTC-BB:AEMD) /
CO: Aethlon Medical, Inc.; 32nd Annual Dialysis Conference
ST: Texas California
IN: HEA MEQ
SU: PDT TDS
PRN
-- LA48745 --
0000 02/07/2012 13:15:00 EDT http://www.prnewswire.com
