Aethlon Medical has obtained approval from the Drug Controller General of India (DCGI) for a potential Phase I trial of its clinical-stage immunotherapeutic device, the Hemopurifier, in oncology.
The company will carry out the safety, feasibility and dose-finding study of this device in patients with solid tumours who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Opdivo or Keytruda.
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The study is anticipated to start after the completion of the relevant targets’ internal in vitro binding study and subsequent clearance by the respective Ethics Boards of interested sites in the country.
Evaluating the feasibility and safety of patients treated with the Hemopurifier at different treatment intervals and in those with solid tumours with stable or progressive disease after 60 days of pembrolizumab or nivolumab monotherapy will be the study’s primary endpoint.
The trial will also assess the effects of Hemopurifier treatment on the immune response to cancer.
Aethlon Medical CEO Charles Fisher said: “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.
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By GlobalData“The trial is designed to include multiple tumour types, as well as Hemopurifier dosing intervals, to help direct further development of the Hemopurifier for use in oncology.”
The company already received breakthrough device designation from the US Food and Drug Administration for the Hemopurifier device to treat patients with advanced or metastatic cancer who are either unresponsive to or not tolerant of standard-of-care therapy.
It is also intended for the treatment of individuals with cancer types in which exosomes have been shown to take part in the disease development or severity.
The Hemopurifier also has breakthrough device designation and an open investigational device exemption application for the treatment of viruses that could not be treated with approved therapies.
