Aethlon Medical, Inc. Receives Clearance from Drug Controller General of India for Potential Phase 1 Trial of its Hemopurifier(R) in Oncology
October 10, 2023 at 08:01 am
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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.
Aethlon Medical, Inc. (Aethlon) is a medical therapeutic company focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections suppression, seed the spread of metastasis and inhibit the benefit of cancer therapies. The Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression. Hemopurifier helps to bind and clear multiple different glycosylated viruses, such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), Dengue, West Nile, multiple strains of influenza, Ebola, Chikungunya, smallpox, monkeypox, multiple herpes viruses, a MERS-CoV related pseudovirus, and others. Hemopurifier is used as a device for two independent indications: the treatment of individuals with advanced or metastatic cancer and the treatment of life threating viruses that are not approved therapies.