Aethlon Medical Announces Expansion of Compassionate-Use Program To Treat Hepatitis C Virus (HCV)
SAN DIEGO, Dec. 12, 2012 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that a compassionate-use clinical program that provides HCV-infected individuals with access to the Hemopurifier® therapy, has been expanded to include individuals who experience a viral breakthrough during standard-of-care drug therapy.
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, dosing, duration and tolerability of drug therapies. A virologic breakthrough occurs when infected individuals achieve undetectable HCV levels after drug therapy initiation, but then experience a rebound in HCV levels prior to completion of therapy. Researchers often attribute viral breakthroughs to the development of drug resistance or the emergence of HCV subtypes that are less sensitive to drug therapy.
"It is immensely disheartening when HCV-infected individuals initially respond but are then forced to discontinue their drug therapy as the result of a viral breakthrough," stated Aethlon Chairman and CEO, Jim Joyce. "Whether it be interferon-based or future all-antiviral drug strategies, there is an enduring opportunity for our Hemopurifier® to help individuals salvage benefit from their HCV drug regimen."
Aethlon previously disclosed that the compassionate-use program, which was approved by the Institutional Review Board at the Medanta Medicity Institute (Medicity), would allow individuals who previously failed or subsequently relapsed standard-of-care drug regimens with treatment access to the Aethlon Hemopurifier®. Individuals who fail drug therapy maintain detectable HCV levels throughout the course of drug therapy, whereas a treatment relapse is defined when HCV levels decrease and remain undetectable during treatment, but become detectable after cessation of therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. Additional details about the Medicity can be found online at www.medanta.org. Under the compassionate-use program, the Medicity is offering Hemopurifier® therapy to HCV-infected individuals that reside in India or travel from other regions and meet the inclusion/exclusion criteria that have been established for participation.
The Treatment Protocol
The Medicity is offering compassionate-use access to Hemopurifier® therapy on a minimum three-day treatment regimen with the option for patients to extend treatment to a maximum period of seven consecutive days. During each treatment day, Hemopurifier® therapy is administered for a duration of up to six-hours. In HCV-infected individuals who previously failed or subsequently relapsed drug therapy, the goal of Hemopurifier® therapy is to accelerate the early viral kinetic response to drug therapy without adding drug toxicity or interaction risks. More specifically, Hemopurifier® therapy targets to increase immediate and rapid virologic response rates, which correlate with high clinical cure rates. In viral breakthrough patients, the goal of Hemopurifier® therapy is to reset viral load to undetectable levels as a strategy to salvage the continuance and benefit of drug therapy.
Medicity is offering the three-day treatment regimen at $7,235.00 (USD), which includes Hemopurifier® therapy, physician and support fees, hospital lodging, catheter and other consumables. The cost for each treatment day beyond the minimum three-day regimen is $2,295.00. Pre-treatment consult and post treatment monitoring is charged at $200/day and includes transportation to and from hotel.
The Medicity has established the following inclusion and exclusion criteria for candidate patient consideration:
- Males or females 18 years of age and older testing positive for any HCV genotype
- Patients who initially responded to standard-of-care drug therapy, but have since suffered a virologic breakthrough
- Patients who relapsed after completing a previous course of standard-of-care drug therapy
- Null responders or patients 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
- Patients on ACE inhibitors must suspend ACE inhibitor administration for a minimum of six days prior to initiating therapy.
- Karnofsky score ≥ 60
- A more detailed list of inclusion criteria, including blood chemistry requirements will be provided to candidate patients who meet the above criteria
- The subject must be informed of the investigational nature of this study and written informed consent obtained prior to enrollment in this study
- 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 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 immunoregulatory 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. Subjects receiving methadone within the past year are also excluded.)
- Any cancer requiring systemic chemotherapy
- Any other condition that, in the opinion of the Principal Investigators, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
Individuals interested in the study are encouraged to contact:
Dr Puneet Sodhi
Mail ID: puneet.sodhi@Medanta.org
Contact No.: +91-9910002681
Jitendra Kumar Gupta
Mail ID: email@example.com
Contact No.: +91-9313365371
Information requests can also be sent directly to Aethlon Medical at: firstname.lastname@example.org
Current HCV Studies
Aethlon has previously reported data from a clinical program at the Medicity that is evaluating the capability of the Aethlon Hemopurifier® to accelerate HCV RNA depletion at the outset of standard of care peginterferon+ribavirin (PR) therapy. In this study, 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.
The primary clinical endpoint of this study 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 only10.35% (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.
To date, Aethlon has reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in the first 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. Aethlon previously reported undetectable HCV RNA in eight of the 10 treated patients. Of the two patients reported to have detectable HCV RNA, one had 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.
Aethlon expects to report updated results, including new patient data from this study in the near future. The Company also disclosed it is presently incorporating new patient data within investigational device exemption (IDE) that is expected to be submitted to FDA by year-end in an effort to gain approval to initiate HCV clinical programs in the United States.
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. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a contract with DARPA to 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 whether revenue or non-revenue generating from either compassionate use or non-compassionate use 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.