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.

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