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(R) or Opdivo(R). 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. 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.