Aethlon Medical gets go-ahead from DCGI for trial of Hemopurifier

Aethlon Medical, Inc. announced that it has received clearance from the Drug Controller General of India (DCGI), the central drug authority in India, to conduct a phase 1 safety, feasibility and dose-finding trial of the company’s Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®. The trial is expected to begin following completion of an internal in vitro binding study of relevant targets, and subsequent approval by the respective Ethics Boards of interested sites in India.

“Receipt of clearance from the DCGI to conduct this early feasibility study is another important step in the progression of our plan to evaluate use of our Hemopurifier as a treatment option in multiple tumor types, where cancer associated extracellular vesicles may promote immune suppression and resistance to anti-PD-1 antibodies,” stated Charles J. Fisher, Jr., M.D., Chief Executive Officer of Aethlon Medical. “We expect to begin patient recruitment once we have completed an internal in vitro binding study to confirm that relevant targets are bound by the Hemopurifier, and after we receive subsequent approval by the Ethics Boards of the interested sites for the trial in India. The planned oncology trial in India is designed to be a safety study in nine to 18 patients to examine three cohorts of Hemopurifier treatments in patients receiving pembrolizumab (Keytruda) or nivolumab (Opdivo) therapy as standard of care for their malignancy. The trial is designed to include multiple tumor types, as well as Hemopurifier dosing intervals, to help direct further development of the Hemopurifier for use in oncology.

The trial’s primary endpoint will be to assess the safety and feasibility of the Hemopurifier-treated patients at different treatment intervals in patients with solid tumors with stable or progressive disease after 60 days of pembrolizumab or nivolumab monotherapy. Additionally, the effects of Hemopurifier treatment on the immune response to cancer will be assessed.

“Additionally, we continue to work with our contract research organization, North American Science Associates, LLC (NAMSA), to initiate a similar oncology clinical trial in Australia; specifically, a safety, feasibility and dose finding trial in solid tumors in patients failing treatment with anti-PD-1 antibodies. We believe these planned trials will help inform future oncology efficacy trials with our Hemopurifier,” concluded Dr Fisher.
MB Bureau