Aethlon Medical releases HCV treatment protocol details for Hemopurifier medical device...

Posted 10/2/2012 on Fox News.com. Aethlon Medical, Inc, whose Hemopurifier filtration device is being studied in India for a variety of indications including HCV, has released their HCV treatment protocol and inclusion/exclusion criteria for their compassionate-use commercialization program. The hope is that the Hemopurifer can be used in combination with Peg/Riba and perhaps future Direct Acting Antivirals to accelerate the decrease of HCV RNA, time on drug therapy as well as increasing the likelihood that patients achieve SVR.  This protocol is targeting null, partial and relapsers to previous Peg/Riba therapy. Further information on therapy pricing is to be released in coming weeks.

The treatment objective will be to accelerate the rate and increase the likelihood that patients achieve undetectable HCV RNA.

Aethlon Medical Releases Hepatitis C Virus (HCV) Treatment Protocol and Inclusion/Exclusion Criteria Underlying Compassionate-Use Commercialization Program

SOURCE Aethlon Medical, Inc.

SAN DIEGO, Oct. 2, 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, 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, Inc.

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 this expanded treatment program will augment the company's current government contract revenue stream, 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

©2012 PR Newswire. All Rights Reserved.

Medical Device industry makes a run at Pharma in the HCV space...

Posted 8/9/12 on The OTC Investor.com. Aethlon Medical is serious about it's Hemopurifier, a blood filtration device being looked at for several indications. If it is indeed capable of lowering HCV viral load to a point where pegylated interferon and ribavirin could be more effective and bump up response rates over 50% with less toxicity... and can do so at a cost lower than that of Direct Acting Antiviral combination therapy... Aethlon may be on to something. Yet another reason not to dismiss interferon just yet. 

Bristol’s Halted Hepatitis C Trial Reinforces Aethlon Medical’s Non-Toxic Therapy
By Paul Archie · Thursday, August 9th, 2012

In the biotechnology world, the sun rises and set around the two key words “safety” and “efficacy.”  A serious safety concern last week resulted in Bristol-Myers Squibb (NYSE: BMY) voluntarily halting its ongoing Phase 2 study of BMS-986094, a drug in development as a new indication for hepatitis C as part of the drug maker’s quest for an all-oral regimen for hep C.  A patient who had received a 200 milligram dose of the nucleotide polymerase inhibitor, or “nuke,” suffered heart failure; causing Bristol to stop the trial and begin evaluating participants to determine any correlation between the new drug and the heart damage.

In February, Bristol paid $2.5 billion to acquire Inhibitex, a 163-percent premium to the valuation of Inhibitex at that time, primarily to snag its hepatitis C drug candidate (then called INX-189).  The halted trial could seriously hamper Bristol in its race with Gilead (NASDAQ: GILD) and Abbott Labs (NYSE: ABT) to bring a new hepatitis C drug to market.  It is widely expected that an all-oral drug therapy for the liver disease that affects about 170 million people across the world will generate billions annually in sales.  It is the reason that Bristol paid the premium for Inhibitex and Gilead dished-out $11.1 billion last November to acquire Pharmassets and its hep C drug in development.

Investors that recognize the upside potential of new therapies for hepatitis C should be taking a close look at Aethlon Medical (OTCBB: AEMD), the maker of a first-in-class blood filtration device called the Hemopurifier®.  Recently released clinical research by Aethlon showed that the two most recent hepatitis C-infected patients to receive its Hemopurifier® therapy in combination with the standard of care peginterferon+ribavirin (PR) drug therapy achieved undetectable viral load at day-7.  In lay terms, that means that none of the hepatitis C virus was found in the patients’ bloodstream after seven days of treatment.

As an adjunct, the Aethlon Hemopurifier® selectively targets the rapid clearance of the hepatitis C virus from the entire circulatory system to improve benefit, dose, duration and tolerability of drug therapies.  Drugs, like that of Bristol, Gilead or Abbott, carry substantial safety risks because they are “additive” in nature, meaning that they are putting a foreign substance into the body.  Aethlon’s Hemopurifier® is “subtractive.”  It removes the virus through a proprietary filtering process, which does not carry the same, potentially deadly toxicity risks that can cost major pharma billions to finally realize.

The OTC Investor (http://s.tt/1kpgX)

Aethlon Medical Reports Undetectable Hepatitis C Virus (HCV) in Genotype 1, Genotype 3, and Genotype 5 Patients Treated with Hemopurifier® Therapy

Posted on 5/8/12 on MarketWatch.com. Good news for San Diego's microtech, Aethlon Medical in the form of a trial results looking at it's Hemopurifier filtration device in combination with pegylated interferon and ribavirin in patients infected with HCV genotype 1, 3 and 5. The hemopurifier is a first-in-class device that selectively targets HCV by filtering the circulatory system for virus thus enhancing the work of traditional oral and injectable anti-HCV drugs. If proven effective, Hemopurifier could be a great asset to HCV providers by possibly being able to lower the dose and duration of HCV therapy - and, given the cost of the 1st generation of oral anti-HCV Direct Acting Antivirals - could provide a cost benefit as well. The Hemopurifier seems to be very effective in genotype 1 patients which is encouraging - if just pegylated interferon and ribavirin are used there is not only a possible cost benefit, but also a possible greatly reduced propensity for the patient to develop drug-resistant variants. Further studies are needed of course, but this initial bit of news is encouraging. 


Aethlon Medical Reports Undetectable Hepatitis C Virus (HCV) in Genotype 1, Genotype 3, and Genotype 5 Patients Treated with Hemopurifier® Therapy

SAN DIEGO, May 8, 2012 /PRNewswire via COMTEX/ -- Aethlon Medical, Inc. AEMD +22.68%  , the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, reported today that the presence of Hepatitis C virus (HCV) is currently undetectable in all infected patients that have been treated with the Aethlon Hemopurifier® in combination with peginterferon+ribavirin (PR) drug therapy and monitored for at least ninety days.

In a study conducted at the Medanta Medicity Institute (Medicity), HCV-infected individuals were enrolled to receive up to three, six-hour Hemopurifier® treatments during the first three days of PR drug therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. 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, dose, duration and tolerability of drug therapies.

In the Medicity study, Aethlon reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in nine treated patients. Of these nine patients, six patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. Of the nine reported patients, seven have been monitored for more than ninety days. All seven currently maintain undetectable viral load, including three patients who have been monitored for 48-weeks. Two patients initiated Hemopurifier® therapy on April 18th and April 30th, and therefore have not yet been monitored for extended viral load suppression.

The Immediate Impact of Hemopurifier® Therapy

In addition to demonstrating safety and early efficacy against multiple HCV genotypes, a clinical objective of the Medicity study was to evaluate whether the Hemopurifier® could accelerate HCV eradication to levels associated with treated patients who achieve the highest rate of viral cure, including individuals that previously failed or relapsed PR drug regimens. In the study, Aethlon observed that viral load depletion during the Hemopurifier® + PR drug therapy phase was greatest in hard-to-treat genotype-1 patients with high viral load. In one treated patient, baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured after the third day of Hemopurifier® + PR therapy, representing a 3.49 log or 99.96% reduction of viral load. In another patient, baseline HCV RNA dropped from 8,760,000 IU/ml to 4,665 IU/ml when measured on day-3, representing a 3.27 log or 99.96% reduction. By contrast, a moderate viral load Hemopurifier® patient with baseline HCV RNA of 1,340,000 IU/ml dropped to 54,900 IU/ml when measured on day-3, representing a 1.38 log or 95.9% reduction.

As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that less than 5% of treated patients will achieve a 2-log or greater reduction of viral load when measured 7-days after the start of PR drug therapy. While the IDEAL study did not report day-3 viral load, a 2-log+ reduction at day-7 is a rare occurrence defined as an immediate virologic response (IVR). The IDEAL study confirms the viral cure or sustained virologic response rate of IVR patients to be greater than 90%. Based on Medicity treatment outcomes, Hemopurifier® therapy had a significant impact in accelerating HCV eradication in high viral load patients.

Capacity of the Hemopurifier® to Capture HCV During Treatment

As the result of discussions with reviewers at the Center for Devices and Radiological Health (the FDA branch responsible for approving medical devices in the US), Aethlon recently expanded the Medicity protocol to establish a data point that would quantify the amount of HCV captured within the Hemopurifier® during a single treatment. In one analyzed cartridge, researchers recovered and measured that approximately 300 billion (300,000,000,000) copies of HCV had been captured within the Hemopurifier® during a single six-hour treatment at the Medicity. Beyond the impact of inhibiting progeny virus replication, the viral capture data point defines the contribution Hemopurifier® therapy can provide to current and future antiviral drug treatment regimens. Aethlon considers this data point to be unprecedented as the previous ability to measure the benefit of HCV therapies has primarily been limited to measuring changes in the amount of virus that can be detected in circulation.

Next Steps

As a result of Hemopurifier® + PR therapy outcomes, Aethlon has requested permission from the Medicity internal review board (IRB) to begin offering Hemopurifier® therapy to HCV-infected individuals that reside outside of India. The Company has also requested IRB permission to expand the treatment protocol to allow for up to seven Hemopurifier® treatments to be administered during the first week of PR drug therapy. Based on previous three-treatment protocol outcomes, Aethlon anticipates an expanded Hemopurifier® dosing schedule could establish new milestones for early undetectable viral load achievement. The Company also disclosed it will resubmit an investigational device exemption (IDE) which incorporates the Medicity data as part of its effort to gain FDA approval to initiate clinical programs in the U.S.

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. To date, almost 100 Hemopurifier® treatments have been administered in human studies. Previously, studies of the Hemopurifier® have been conducted at the Apollo, Fortis, and Sigma New Life hospitals in India. These studies demonstrated that Hemopurifier® therapy could safely reduce viral load in both HIV and HCV-infected dialysis patients without the administration of antiviral drug therapies. The Medicity study represents the first Hemopurifier® study in non-dialysis patients. In vitro studies have further validated the ability of the Hemopurifier® to capture a broad-spectrum of viral pathogens classified as bioterror or pandemic threats.

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(TM) 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(TM) product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome(TM) 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 FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies of the Aethlon ADAPT(TM) system or 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. These statements, including patient data, are based on information currently available to the Company's management and future patient results may differ from present results. 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. JoyceChairman and CEO858.459.7800 x301jj@aethlonmedical.com

Jim FrakesChief Financial Officer858.459.7800 x300jfrakes@aethlonmedical.com

Marc Robins877.276.2467mr@aethlonmedical.com

SOURCE Aethlon Medical, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

Aethlon Medical requests FDA meeting to expand Hemopurifier® indications to include HCV...

Pretty compelling idea using Aethlon Medical's Hemopurifier® therapeutic filtration system as adjunct therapy to HCV therapy to improve outcomes in special populations. Essentially, the filtration system is used to lower HCV viral load in combination with standard-of-care therapy and possibly DAAs to improve SVR rates. This would especially be useful in patients where ribavirin would be risky or contraindicated (post-transplant, hemodialysis). Depending on the FDA response, I hope the potential trials turn out to be as compelling in reality as they appear to be on paper.


Aethlon Medical Discloses FDA Meeting Request and Proposed Expansion of U.S. Treatment Indications to Include Hepatitis C Virus (HCV)

SAN DIEGO, May 9, 2011 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD) announces that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States. As part of these discussions, Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV). Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S. At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.

"Since submitting our IDE, we have expanded our collection of human safety data, which has also provided insight that our Hemopurifier® can have a substantial effect in reducing viral load in HCV-infected patients even in the absence of antiviral drugs," stated Jim Joyce, Chairman and CEO of Aethlon Medical. "These results combined with the emergence of a remarkable clinical validation for therapeutic filtration in HCV care provide a compelling basis for an FDA meeting to discuss and advance a potential clinical strategy to treat HCV-infected individuals in the United States."

The meeting with the FDA will provide a collaborative opportunity for Aethlon management to interact directly with Agency officials and to obtain guidance and input on advancing both its HCV and Medical Countermeasure indications in the U.S. Aethlon anticipates a meeting with FDA officials will likely occur in mid-summer.

The Company believes a significant and enduring opportunity exists for the Hemopurifier® as an adjunct to improve the benefit of current, forthcoming and future iterations of standard-of-care drug therapy (SOC) by accelerating viral load depletion in the first few days of HCV-SOC. The clinical validation for therapeutic filtration of HCV has been established by the VRAD system developed and marketed by Asahi Kasei Kuraray Medical in Japan. The early administration of VRAD in combination with HCV-SOC achieved 71.4% sustained virologic response rates (SVR) in HCV patients who previously failed HCV-SOC. These results were achieved through a once daily administration of VRAD for three consecutive days at the outset of SOC therapy. The average viral load reduction during each treatment period, which averaged 3 1/4 hours in duration, was 26.1%. In comparison, the Aethlon Hemopurifier® has demonstrated average viral load reductions of 64% during similar treatment timeframes in the absence of any drug therapy benefit. Aethlon is now actively advancing an adjunct study to demonstrate the ability of the Hemopurifier® to accelerate early viral load depletion in patients who initiate HCV-SOC. The study is being conducted at the Medanta Medicity Institute in Delhi, India.

The Hemopurifier® is also uniquely suited to treat HCV-infected End-stage renal disease (ESRD) patients, whose condition limits their ability to be treated with HCV-SOC. The incidence of HCV infection in ESRD patients is approximately 100-1000 times higher than that in the general population. Recent studies have clearly shown that HCV-infected ESRD patients on maintenance dialysis are at increased risk of liver-related mortality. A significant proportion develops chronic hepatitis, cirrhosis, and even hepatocellular carcinoma. Overall, chronic HCV patients on hemodialysis bear an increased risk of liver-related morbidity and mortality, either during dialysis or after renal transplantation. Interferon (IFN) therapy is modestly effective for the treatment of HCV infection in ESRD patients but is not recommended after renal transplantation due to the risk of acute graft rejection. Ribavirin is considered contraindicated for the treatment of ESRD patients with chronic hepatitis C because of the risk of life-threatening hemolytic anemia. A major advantage in treating HCV-infected ESRD patients with the Hemopurifier® is that the device adds no drug toxicity or interaction concerns and can be included in series with a patient's dialysis cartridge, thus adding no treatment burden beyond the patient's pre-established dialysis treatment schedule.

Aethlon further disclosed that it will begin discussions with the FDA on the regulatory requirements to obtain an Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats that emerge naturally or are released by man as an agent of bioterrorism. The Project BioShield Act of 2004 permits the FDA Commissioner to authorize the use of an unapproved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The EUA authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological and nuclear agents that may be used to attack the American people or the U.S. armed forces. The FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives.

Aethlon believes the Hemopurifier®, which is the sole antiviral strategy to address drug and vaccine resistant viral pathogens, is well positioned to meet the U.S. government's urgent need for innovative new medical countermeasures that can be deployed during national health emergencies.

About Aethlon Medical

At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.

Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.

Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.

As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:

1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.


The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.

In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.

Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at 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 FDA's willingness to meet with company officials to discuss re-initiation of an Investigational Device Exemption (IDE) study, or the FDA's willingness to meet with company officials to discuss Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its 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, CEO
858.459.7800 x301
jj@aethlonmedical.com

Jody Cain
Senior Vice President, Lippert/Heilshorn
310.691.7100
jcain@lhai.com

Jim Frakes
Chief Executive Officer
858.459.7800 x 300
jfrakes@aethlonmedical.com

John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com

SOURCE Aethlon Medical, Inc.
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Aethlon Medical starts patient enrollment of Hemopurifier in battle against HCV...

From the PharmaLive.com News Archive - Oct. 21, 2010
SAN DIEGO, Oct. 21 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today it has established primary clinical endpoints and clarified efficacy assessments related to a study that will evaluate the use of the Aethlon Hemopurifier® in combination with standard of care (SOC) HCV drug therapy.  As a result, Aethlon will now initiate the recruitment of candidate patients and begin exporting its Hemopurifier® for clinical purposes.  The study will be conducted at Medanta, The Medicity Institute (Medicity), which is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system.

A primary clinical goal of the study will be to demonstrate that the Aethlon Hemopurifier® improves the acceleration of viral load depletion when administered at the outset of SOC drug therapy. Clinical endpoints of the study will assess Early Viral Response (EVR) rates, Rapid Viral Response (RVR) rates, as well as Immediate Viral Response (IVR) rates, which are all highly predictive of a sustained viral response (SVR), which is defined as undetectable viral load six months after the completion of SOC drug therapy.  As the Hemopurifier® is designed to decrease the presence of circulating HCV virus, Aethlon will also seek to quantify the amount of HCV captured within the Hemopurifier® after the first application of the device in each enrolled patient. A lower body burden of HCV at the outset of SOC also correlates with improved treatment outcomes.

Early Viral Response (EVR)
As reported in the McHutchinson, et al 2009 study of 1,019 genotype I patients who initiated 48-week standard dose SOC PegIFN-a2b therapy, 39.9% of treated patients achieved an EVR.  Those patients who achieved an EVR, which represents undetectable viral load at day 90 of SOC treatment, achieved 99% SVR rates, representing an improved clinical benefit of greater than 200% as compared to patients that do not achieve an EVR.  A clinical goal of the Hemopurifier® study will be to increase the established likelihood that patients achieve an EVR.

Rapid Viral Response (RVR)
Also reported in the McHutchinson, et al 2009 study of 1,019 genotype I patients who initiated 48-week standard dose SOC PegIFN-a2b therapy, only 11.4% of treated patients achieved a RVR, which is defined as undetectable viral load at day 30.  However, those patients who achieved an RVR had SVR rates of approximately 90%, which represents a clinical benefit greater than 100% as compared to patients that do not achieve an RVR.  An additional clinical goal of the Hemopurifier® study will be to increase the likelihood that patients achieve an RVR.

Immediate Viral Response (IVR)
Aethlon will also seek to demonstrate that the addition of the Hemopurifier® to SOC drug therapy improves Immediate Viral Response (IVR) rates as compared to patients who receive SOC alone.  IVR, also known as first-phase kinetics, will be determined by measuring viral load at the end of day one (1), day two (2), day three (3), and day seven (7).  In this regard, an additional clinical goal will be to demonstrate the application of the Hemopurifier® in combination with SOC improves first-phase viral depletion kinetics in enrolled patients.
The principal investigator of the clinical study, which has been registered with the Clinical Trials Registry of India, will be 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® human studies to treat HCV at the Apollo and Fortis hospitals in Delhi, India. The Apollo and Fortis studies demonstrated safety and the effectiveness of the Hemopurifier® to reduce viral load in the absence of drug therapy. Patients enrolled in the Medicity study will receive a maximum of six Hemopurifier® treatments within the first week of initiating SOC drug therapy.   The study will enroll up to 30 patients.

Upon the demonstration of improved clinical outcomes, Aethlon plans to advance commercialization through the Medicity and other regional treatment centers in India. The company has entered into an agreement with GVK Biosciences (GVK BIO) to expand the opportunity for Aethlon to commercialize its Hemopurifier® treatment technology at three to five new clinical centers in India.  GVK BIO is Asia's leading Discovery Research and Development organization. The HCV treatment opportunity for Aethlon is significant as it is estimated that 20 million of the 180 million people infected with HCV worldwide reside in India.  Based on patient feedback, Aethlon also believes that citizens of other nations that are infected with HCV may choose to travel to India to seek out new therapies that could help address their HCV infection. However, Medanta's Independent Ethics Committee (MIEC) has not yet approved the enrollment of treatment candidates who reside outside of India.

Aethlon Medical's Hemopurifier moves forward at Medicity...

SAN DIEGO, Aug. 26 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that the Medanta Independent Ethics Committee (MIEC) at Medanta, The Medicity Institute (Medicity) has approved a treatment program entitled: "Use of the Aethlon Hemopurifier® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy."  The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. The Aethlon Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system.  A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates.

"We are grateful for this opportunity to show the pharmaceutical industry, infected patients, and shareholders that our Hemopurifier® can enhance the capabilities of drug regimens without adding additional drug toxicity and interaction risks", stated Aethlon Chairman and CEO, Jim Joyce. "Beneficial outcomes will set the stage for the early commercialization of our technology and should recalibrate industry viewpoints on addressing infectious disease conditions."

Upon the demonstration of early treatment benefit, Aethlon plans to advance commercialization through the Medicity and other regional treatment centers in India. In this regard, the company has entered into an agreement with GVK Biosciences (GVK BIO) to expand the opportunity for Aethlon to commercialize its Hemopurifier® treatment technology at three to five new clinical centers in India. GVK BIO is Asia's leading Discovery Research and Development organization. The HCV treatment opportunity for Aethlon is significant as greater than 20 million of the estimated 180 million people infected with HCV worldwide reside in India.  Based on patient feedback, Aethlon also believes that citizens of other nations may chose to travel to India to seek treatments that could resolve their HCV infection.

Aethlon further disclosed that the principal investigator of the clinical program, which has been registered with the Clinical Trials Registry of India, will be 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® human studies to treat HCV at the Apollo and Fortis Hospital in Delhi, India. These studies demonstrated safety and effectiveness of the Hemopurifier® to reduce viral load in the absence of drug therapy. Patients enrolled in the Medicity study will receive a maximum of six Hemopurifier® treatments within the first week of initiating SOC drug therapy. In addition to monitoring for improved acceleration of viral load reduction at the outset of SOC, another primary endpoint will focus on rapid viralogic response (RVR) which is defined as undetectable viral load 30 days after SOC initiation. On average, approximately 15% of patients who initiate SOC therapy achieve a RVR.  Yet, those able to achieve a RVR have a greater than 88% likelihood of achieving a sustained viralogic response. The initiation of patient enrollment for the Medicity is conditional upon maintaining the treatment protocols approved by the MIEC and that clinical endpoint / efficacy assessment be further clarified by the principal investigator. Aethlon has also agreed to give consideration to compensating enrolled patients for lost wages while receiving Hemopurifier® treatment and other consideration should a material adverse event occur as a result of Hemopurifier® therapy.

Aethlon Medical, Inc announces Hemopurifier® expansion into Hepatitis C...

Aethlon Medical Announces Expansion of Hepatitis C Virus (HCV) Treatment Programs

PR Newswire US - Aug. 18, 2010

SAN DIEGO, Aug. 18 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, today announced that it has entered into an agreement with GVK Biosciences (GVK BIO) to expand the opportunity for Aethlon to commercialize its Hemopurifier® treatment technology at three to five new clinical centers in India.  The therapeutic focus at each center will be the implementation of the Hemopurifier® as an adjunct therapy to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with patients most likely to achieve a sustained viral response, which is the goal of HCV therapy.  GVK BIO is Asia's leading Discovery Research and Development organization.

Aethlon further disclosed that the Ethics Review Board (ERB) at Medanta, The Medicity Institute (Medicity) met on August 14th, 2010 to discuss the potential approval for Aethlon to initiate HCV treatment programs at the Medicity. Aethlon has been advised that a formal response should be expected from the Medicity ERB in the coming weeks. The Medicity is a $360 million facility recently established on a 43-acre campus to be a premier center of medical tourism in India.

About GVK Biosciences

GVK Biosciences (GVK BIO) is Asia's leading Discovery Research and Development organization. GVK BIO provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. GVK BIO's diverse portfolio of more than 100 customers includes Big Pharma, Agri & Life-sciences companies, leading biotechs and academic institutions. Spread across five locations in India and headquartered in Hyderabad, GVK BIO assists clients accelerate their research.  Additional information can be accessed at www.gvkbio.com.

About Aethlon Medical

At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.

Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.

Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs.  However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union.  In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.

As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:

1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.  
3. Human Immunodeficiency Virus (HIV):  Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats:  Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.

The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.

In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.

Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.