Aethlon Medical Readies for Phase 1 Cancer Treatment Trials

Aethlon Medical, Inc., a company dedicated to developing therapies for cancer and severe infectious diseases, has provided an update on its phase 1 clinical trials for the Hemopurifier®. These trials are aimed at patients with solid tumors who are not responding to anti-PD-1 monotherapy treatments, such as Keytruda® and Opdivo®.

The company, which is listed on Nasdaq, is moving forward with the safety, feasibility, and dose-finding trials in Australia and India. Chief Medical Officer Steven LaRosa, MD, noted the recent strides made in preparing for these trials. In May, new data demonstrated the Hemopurifier's ability to remove exosomes from cancer patient plasma in vitro, using a smaller version of the device. These findings have been swiftly integrated into the necessary documentation for Ethics Committees at potential clinical sites.

By mid-May, Aethlon had submitted these documents to the Contract Research Organizations involved in the trials. Following this, one site submitted the documentation to its Ethics Board on May 24, 2024. Other sites in Australia and India are in the process of assembling their packages for Ethics Committee submission. Upon receiving the expected approvals, the company plans to finalize Clinical Trial Agreements, allowing hospitals to start patient recruitment.

The target group for these trials includes oncology patients with solid tumors who are not experiencing success with their current anti-PD-1 treatments.

Aethlon Medical specializes in the Hemopurifier®, a clinical-stage immunotherapeutic device designed to tackle cancer and dangerous viral infections, and to support organ transplantation. The Hemopurifier® has shown effectiveness in removing life-threatening viruses in human studies and harmful exosomes in pre-clinical studies. These exosomes can contribute to immune suppression and metastasis in cancer, highlighting the potential applications of the Hemopurifier® in oncology and infectious diseases.

The Hemopurifier® has been recognized by the U.S. Food and Drug Administration (FDA) as a Breakthrough Device. It is intended for advanced or metastatic cancer patients who do not respond to or cannot tolerate standard therapies, particularly for cancer types where exosomes are involved in disease progression. Additionally, the Hemopurifier® has an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application for treating life-threatening viruses not addressed by approved therapies.

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