From the Wires
Aethlon Medical Announces Initiation of Compassionate-Use Program to Treat Hepatitis C Virus (HCV)
By: PR Newswire
Dec. 3, 2012 06:00 AM
SAN DIEGO, Dec. 3, 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 announced the initiation of a compassionate-use clinical program to treat individuals infected with Hepatitis C virus (HCV). The compassionate-use program, which has been approved by the Institutional Review Board at the Medanta Medicity Institute (Medicity), will provide individuals who previously failed or subsequently relapsed standard-of-care drug regimens with treatment access to the Aethlon Hemopurifier®. The 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.
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.
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. The opportunity to address infected individuals who fail or subsequently relapse drug therapy is significant as retreatment prognosis with drug therapy alone is often poor. 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.
"We are grateful to the Medicity for providing us the opportunity to improve Hepatitis C treatment outcomes," stated Aethlon Chairman and CEO, Jim Joyce. "While we plan to be cautious in our initial ramp-up, we do look forward to augmenting our established contract revenue stream with Hemopurifier® product sales."
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 up to six-hours. In HCV, the goal of therapy is to accelerate the early viral kinetic response to standard-of-care 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.
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:
Individuals interested in the study are encouraged to contact:
Dr Puneet Sodhi
Jitendra Kumar Gupta
Information requests can also be sent directly to Aethlon Medical at: email@example.com
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 theseten 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
SOURCE Aethlon Medical, Inc.
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