Aethlon Medical, Inc. (Nasdaq: AEMD) has announced the enrollment of the first two patients in its clinical trial evaluating the Hemopurifier® device for patients with solid tumors that have not responded to anti-PD-1 antibodies. This marks a significant milestone for the company's oncology program.
The safety, feasibility, and dose-finding study is underway in Australia, with the first two patients enrolled at the Royal Adelaide Hospital. Pindara Private Hospital, located on the Gold Coast, has also been approved and trained to enroll patients. A third Australian hospital is awaiting ethics committee approval before it can begin enrolling patients. A similar trial has received ethics committee approval from Medanta Medicity Hospital in Gurugram, India, and is preparing to open for patient enrollment.
Trial Design and Objectives
The trial aims to enroll approximately nine to 18 patients to assess the safety of the Hemopurifier device. Patients with solid tumors and stable or progressive disease, who have undergone a two-month run-in period of PD-1 antibody monotherapy (Keytruda® or Opdivo®) without response, are eligible for the study. Participants will receive one, two, or three Hemopurifier treatments over a one-week period. The primary endpoint is safety, monitored through adverse events and changes in lab tests.
In addition to safety, the study will explore the number of Hemopurifier treatments needed to reduce the concentration of extracellular vesicles (EVs) and whether these changes improve the body's ability to attack tumor cells. These analyses are intended to inform the design of future efficacy and safety trials, including a Premarket Approval (PMA) study required by the FDA.
Rationale for Hemopurifier Use
Currently, only about 30% of patients treated with pembrolizumab or nivolumab experience lasting clinical responses. Tumor-produced extracellular vesicles (EVs) have been implicated in cancer spread and resistance to anti-PD-1 therapies. The Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially enhancing therapeutic response rates to anti-PD-1 antibodies. Preclinical studies have demonstrated the Hemopurifier's ability to reduce EVs in cancer patient plasma samples.
Management Commentary
"This represents a critical milestone for the safety, feasibility and dose-finding trials of the Hemopurifier in patients with solid tumors who have failed treatment with anti-PD-1 antibodies," stated James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "We now have two sites open for patient enrollment in Australia, have received ethics committee approval from a site in India, and we expect to continue to enroll subjects in our Hemopurifier cancer trial."
Financial Update
Aethlon Medical reported a cash balance of approximately $6.9 million as of September 30, 2024. Consolidated operating expenses for the fiscal quarter ended September 30, 2024, were approximately $2.9 million, compared to $3.2 million for the same period in 2023. The company has implemented strategic cost-cutting initiatives to optimize resource allocation and focus on high-impact areas of the oncology trial.
