#Australia #Adelaide #Aethlon Medical #Hemopurifier #cancer trial

Aethlon Medical's Remarkable Step Forward in Cancer Treatment

Aethlon Medical, Inc., a pioneer in medical therapeutics, has marked a significant achievement by successfully treating its very first patient in the Australian clinical trial of the Hemopurifier. This trial, conducted at the Cancer Clinical Trials Unit located at the Royal Adelaide Hospital, aims to explore a novel treatment path for individuals grappling with solid tumors that exhibit stable or progressive conditions despite undergoing anti-PD-1 monotherapy, including notable treatments like Keytruda® and Opdivo®.

The patient was enrolled on October 29, 2024, under the supervision of Professor Michael Brown and his dedicated team at the facility. The treatment with the Hemopurifier device took place on January 29, 2025, facilitated by Professor Toby Coates and the dialysis staff, marking a milestone that has been eagerly anticipated in the oncology community.

During the preceding two months, the patient was monitored while receiving Nivolumab as part of their initial therapy. Observations documented significant data on extracellular vesicles (EVs) and anti-tumor T cell functionality. Post the treatment with the Hemopurifier, which lasted four hours, the patient tolerated the procedure without complications and is now scheduled for follow-up assessments. These will focus on safety metrics, EV counts, T cell measurements, and imaging for clinical responses.

According to Dr. Steven LaRosa, Chief Medical Officer at Aethlon Medical, this initial treatment signifies a pivotal moment in the developmental journey of the Hemopurifier in oncology. He expressed excitement regarding forthcoming data from this cohort, which is expected to provide crucial insights into the interaction between the Hemopurifier, tumor-derived extracellular vesicles, and T cell activity against cancer cells.

The relevance of this trial cannot be overstated, particularly considering that traditional treatments such as pembrolizumab and nivolumab yield durable responses in only 30-40% of patients. Extracellular vesicles produced by tumors play a significant role in cancer dissemination and also contribute to the resistance against established therapies.

Designed to specifically target these EVs, the Aethlon Hemopurifier serves as an extracorporeal device that operates in conjunction with a blood pump. It uses a combination of plasma separation, size exclusion, and affinity binding via a unique plant lectin resin, effectively capturing and removing detrimental EVs from the bloodstream. Previous preclinical studies have affirmed the device's capability to reduce exosome levels in plasma samples from cancer patients.

The current trial, which enlists approximately 18 patients, aims to evaluate safety, feasibility, and dosing trials for the Hemopurifier. Critical endpoints include monitoring adverse events and evaluating significant safety lab changes among those treated, especially in the context of stable or progressive solid tumors after a two-month anti-PD-1 run-in. For participants who experience a lack of response to their initial therapies, a subsequent phase will see them undergo a series of Hemopurifier treatments within a one-week timeline. This part of the study is anticipated to illuminate the necessary frequency of treatments required to effectively diminish EV concentrations, potentially enhancing the body's inherent capacity to fight tumor cells.

In parallel, centralized laboratory analyses will be conducted, which are expected to influence the design of future efficacy studies aimed at substantiating the safety and approval of the Hemopurifier by regulatory bodies.

The Hemopurifier stands as an investigational device boasting accolades such as the U.S. Food and Drug Administration's Breakthrough Device designation. It is uniquely positioned to address the needs of advanced cancer patients, particularly those unresponsive or intolerant to standard-of-care treatments. Aethlon Medical continues to innovate within this realm, paving new avenues for combatting cancer and life-threatening infections.

With this promising trial underway, the anticipation surrounding the Hemopurifier's impact on cancer treatment escalates, offering hope to many who face such daunting health challenges.