Aethlon Medical to Begin U.S. Hemopurifier Trial for Hepatitis C

Aethlon Medical is about to begin the first U.S. Food and Drug Administration-approved study of its Hemopurifier therapy for treatment of the hepatitis C virus (HCV). The San Diego, Calif.-based company’s device is reported to have broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), HCV and numerous bioterror and pandemic threats. According to Aethlon, to date, human studies have demonstrated the Hemopurifier to be safe and provide average viral load reductions of greater than 50 percent during four-hour treatment periods in both HCV and HIV infected individuals without the administration of antiviral drugs. The device is currently the subject of a human clinical study in India to evaluate its ability to accelerate viral load depletion when used in combination with HCV standard of care drug therapy.

In-vitro studies have also documented that the Hemopurifier captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer. Aethlon has expanded its exosome research programs through a collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa Monica, Calif. The SOC collaboration is studying the ex vivo effectiveness of the Aethlon Hemopurifier to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma. Exosomes released by cancers have emerged to become an important therapeutic target in cancer care, as they are implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes assist tumors in evading the response of the immune system.

“Historically, U.S. clinical progression of extracorporeal devices directed toward a single disease indication has been a proven model for value creation,” said Chairman and CEO Jim Joyce. “Our clinical objectives are a bit more ambitious as we aim to navigate Hemopurifier therapy into both cancer and infectious disease indications. Yes, we plan to file an investigational device exemption to treat cancer later this year. We are also investigating emergency use authorization opportunities based on our broad-spectrum bioterror and pandemic threat data and have begun to explore humanitarian use device pathways for orphan conditions that affect fewer than 4,000 individuals in the United States each year.”

The forthcoming feasibility study will recruit 10 HCV-infected end-stage renal disease patients who have not received drug therapy for HCV for at least 30 days. The protocol includes a control phase which consists of three consecutive standard dialysis treatments during week one followed by the inclusion of Hemopurifier for a total of six treatments administered during the second and third weeks. The rate of adverse events observed during the Hemopurifier treatment phase will be compared to the rate experienced during the control phase. Researchers will then examine the viral load and will quantify HCV viral copies captured within the Hemopurifier during each treatment session.

“Successful completion of the feasibility study will set the stage for us to conduct pivotal efficacy studies required for Hemopurifier market clearance,” said Joyce. “The study will also contribute data toward the human safety challenge requirement to advance the Hemopurifier as a broad-spectrum countermeasure against viral bioterror and pandemic threats, whose lethality do not allow for the administration of clinical efficacy studies. Based on our experience conducting a similar protocol overseas, we are cautiously optimistic.”