San Diego based Aethlon Medical, Inc., an innovator in developing targeted therapeutic devices to address infectious disease and cancer, reported final clinical outcomes, including rapid virologic response (RVR) and sustained virologic response (SVR) rates, in persons infected with the Hepatitis-C virus (HCV) who received therapy with Aethlon’s Hemopurifier device.
The results are from a clinical study conducted at the Medanta Medicity Institute in Gurgaon, India — a multi-specialty medical institute established to be a premier center for medical tourism in India, and one of the country’s largest medical research facilities. The next step for Aethlon is preparing the launch of its first human clinical studies in the United States.
The Aethlon Hemopurifier is a new concept bio-filtration device designed to rapidly eliminate viruses and immunosuppressive proteins from infected individuals’ circulatory systems. The Hemopurifier provides a broad-spectrum treatment countermeasure against viral pathogens that are not amenable to treatment with drug or vaccine therapies. In treating HCV, the device is able to address the problem of antiviral drug resistance and cases of hard-to-treat patients unable to tolerate normally administered doses of antiviral drugs or peginterferon+ribavirin (PR). Approximately 170 million people worldwide estimated to be are infected with HCV, which typically causes chronic liver disease or cirrhosis, and is a leading cause of liver transplantation.
In addition to enhanced virologic response RVR and SVR rates, clinical objectives of Aethlon’s HCV study included:
• Demonstration of the safety of Hemopurifier therapy administered to in non-dialysis patients infected with HCV.
• To assess ability Hemopurifier therapy combined with an established therapeutic drug regimen.
• Demonstrating that brief inclusion of Hemopurifier therapy can improve on normally expected benefits of a therapeutic drug treatment.
• Establishment of an elution protocol allowing researchers to quantify the volume of viruses captured by the Hemopurifier during a single treatment.
In the study at Medanta Medicity Institute, HCV-infected participant subjects received three six-hour Hemopurifier treatments during the first three days of a 48-week peginterferon+ribavirin (PR) drug treatment course. The study was conducted under the leadership of Medanta Medicity’s Dr. Vijay Kher. Aethlon reports that Hemopurifier therapy was well tolerated and that no device-related adverse events were observed in the twelve treated patients, ten of whom completed the Hemopurifier-PR treatment protocol. The participants included eight genotype-1 patients and two genotype-3 patients. Eight of the ten patients (n=8/10) achieved a sustained virologic response (SVR) — the clinical definition of a treatment cure defined as undetectable HCV RNA 24-weeks after completion of the 48-week PR drug regimen. Both genotype-3 patients achieved a SVR (n=2/2), while six of the eight genotype-1 patients achieved a SVR (n=6/8)
Five of the ten patients who completed the full treatment protocol (n=5/10) also achieved a rapid virologic response (RVR), defined as undetectable HCV RNA at the thirtieth day of therapy. RVR is regarded as the clinical endpoint best predicting SVR cure rates resulting from PR therapy. As a benchmark reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that 10.35% (n=318/3070) of PR treated patients achieved a RVR. Patients who 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. Aethlon also reports that two of the genotype-1 patients who achieved a RVR also achieved an immediate virologic response (IVR), which is defined as undetectable HCV RNA seven days after initiation of Hemopurifier-PR treatment protocol. The incidence of IVR was not reported in the IDEAL study.
Data from two of the patients was not included in the reported Hemopurifier-PR dataset, one of whom was a genotype-5 patient who discontinued PR therapy at day 180, but who notwithstanding still achieved a SVR. The second dropout was a genotype-3 patient who also achieved a SVR, but who was unable to tolerate PR therapy and discontinued therapy at day 90. Overall, ten of the twelve patients (n=10/12) originally enrolled in the study achieved a SVR and seven of the twelve (n=7/12) patients achieved an RVR.
Aethlon notes that the research team were also successful in achieving the trial objective of establishing an elution protocol allowing them to quantify numbers of viruses captured by the Hemopurifier during a single treatment. As a result, researchers were able to measure as many as 300 billion copies of HCV been captured during a single six-hour treatment.
Aethlon is now preparing to launch the first U.S. clinical Hemopurifier clinical study based on the United States Food and Drug Administration’s (FDA)’s Investigational Device Exemption (IDE) approval protocol. The study, which will be conducted at the DaVita MedCenter Dialysis, in Houston, Texas, will provide more safety data to support advancement of Hemopurifier therapy as a broad-spectrum countermeasure against bioterror and pandemic threats in addition to chronic viral pathogens like HIV and HCV.
Hemopurifier therapy is currently also available to treat Ebola patients in the U.S. through FDA expanded access “emergency use” provisions to address life threatening circumstances for which no alternative approved therapy is available. At present, no antiviral therapy or vaccine has been proven effective against Ebola infection in humans.
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Aethlon Medical, Inc.
Medanta Medicity Institute
Aethlon Medical, Inc.
Medanta Medicity Institute