Aethlon Medical out of San Diego, CA has been investigating its Hemopurifier extracorporeal blood filtration device that has the potential to help manage a number of infectious diseases, as well as remove tumor-derived exosomes related to certain cancers.
Now the company has announced that its technology has been given an FDA Investigational Device Exemption (IDE) to be tested in human feasibility studies for treatment of Hepatitis C. The first phase will involve ten patients with end stage renal disease that are infected with Hep. C who’ll receive treatment with the Hemopurifier. Once the safety of the procedure is established, further clinical trials will focus on the efficacy of the device.
More details from the announcement:
Specific to the treatment of HCV, the Hemopurifier is uniquely positioned as an adjuvant to be incorporated with either interferon-based standard of care (SOC) or emerging all-antiviral drug regimens without adding drug toxicity. In addition to augmenting the early viral kinetic response to SOC, the Hemopurifier is a candidate solution for viral rebound patients who traditionally are forced to discontinue therapy at the point HCV establishes resistance to drug regimens. Additionally, the Hemopurifier addresses the large population of HCV-infected ESRD patients for which SOC and emerging all-antiviral strategies may be contraindicated or not yet cleared. According to the World Health Organization (WHO), HCV is a blood-borne pathogen that affects upwards of 170 million persons, or 2-3% of the world’s population. It is a leading cause of cirrhosis and liver transplantation.
The FDA approved Hemopurifier therapy feasibility study calls for a single-site enrollment of ten HCV-infected end-stage renal disease (ESRD) patients who have not received any pharmaceutical therapy for their HCV infection for at least 30 days. The protocol consists of a control phase which consists of three consecutive standard dialysis treatments during week one followed by the inclusion of the Hemopurifier during a total of six dialysis sessions conducted during weeks two and three. The rate of adverse events observed during the Hemopurifier therapy phase will be compared to the rate experienced during the control phase. Per-treatment changes of viral load will be observed through quantitative PCR analysis. Additionally, Aethlon may also choose to quantitate HCV viral copies captured within the Hemopurifier during each treatment session.
In studies previously conducted in India, Hemopurifier therapy was demonstrated to be well tolerated in treatment naïve HIV and HCV-infected ESRD patients when included during normally scheduled four-hour dialysis sessions. In these studies, average per treatment viral load reductions were observed to exceed 50% in both disease conditions. In follow-on studies of non-ESRD individuals infected with HCV, a three-treatment protocol of Hemopurifier therapy in combination with interferon-based standard of care (SOC) resulted in undetectable HCV in as little as seven days in hardest to treat genotype-1 patients. The studies also documented the ability of the Hemopurifier to capture as many as 300 billion HCV copies during a single six-hour treatment.