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Aethlon Medical expands access to Hemopurifier therapy for Hepatitis C Virus

Aethlon Medical : 13 August, 2012  (Company News)
Aethlon Medical is to establish a treatment programme that will provide HCV-infected individuals with expanded access to Hemopurifier therapy.
The programme 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.

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.  Details related to treatment protocol, inclusion criteria, patient approval processes and therapy pricing are anticipated in September.  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 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. The Medicity is a $360 million multi-specialty medical institute established to be a premier centre for medical tourism in India.

"The Medicity access program represents an important milestone in our quest to establish the selective therapeutic filtration industry," said Aethlon Chairman and Chief Executive Officer, Jim Joyce.  "Beyond helping HCV-infected individuals overcome their disease, we now have the opportunity to augment our established government contract revenues with Hemopurifier product sales."

Aethlon also disclosed that it will continue conducting a study 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.  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 has reported that the two most recent HCV infected patients to receive 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 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 percent (n=318/3070) of PR treated patients achieved a RVR.  

However, patients that achieved a RVR had SVR rates of 86.2 percent (n=274/318) versus SVR rates of 32.5 percent (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 percent (n=131/3070) of patients achieved undetectable HCV RNA at day-14, which equated to a 91 percent (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 percent) 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 d ay-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.  

In addition to expanding access to Hemopurifier therapy at the Medicity, Aethlon is preparing to resubmit to the FDA an investigational device exemption (IDE), which will incorporate the Medicity data in an effort to gain approval to initiate HCV clinical programmes in the United States.
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