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Aethlon Medical to Present Hepatitis C (HCV) Treatment Technology at the 32nd Annual Dialysis Conference

Tue, 02/07/2012 - 3:45am
The Associated Press

/FROM PR NEWSWIRE DALLAS 888-776-3971/

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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

jj@aethlonmedical.com

Jim Frakes Chief Financial Officer 858.459.7800 x300

jfrakes@aethlonmedical.com

John P. Salvador Director, Communications 858.459.7800 x307

jps@aethlonmedical.com

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

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