Aethlon Medical Releases Hepatitis C Virus (HCV) Treatment Protocol and Inclusion/Exclusion Criteria Underlying Compassionate-Use Commercialization Program
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.
James A. Joyce
Chairman and CEO
Chief Financial Officer
SOURCE Aethlon Medical, Inc.