SAN DIEGO - Aethlon Medical, Inc. (NASDAQ:AEMD), a medical device company, has announced the commencement of patient screening and enrollment at the Royal Adelaide Hospital for a clinical trial of the Hemopurifier in patients with solid tumors. This trial, which began on Monday, follows approvals by the Human Research Ethics Committee at Central Adelaide Local Health Network (LON:NETW) on June 13, 2024, and the Research Governance office at Royal Adelaide Hospital on September 3, 2024.
The study, led by Prof. Michael Brown at the Cancer Clinical Trials Unit in Australia, aims to assess the safety, feasibility, and optimal dosing of the Hemopurifier treatment in patients whose solid tumors have not responded to anti-PD-1 antibodies like Keytruda (pembrolizumab) or Opdivo (nivolumab). The device, which has received FDA Breakthrough Device designation, is designed to bind and remove extracellular vesicles (EVs) from the bloodstream that may contribute to cancer spread and resistance to anti-PD-1 therapies.
Approximately 30% of patients receiving pembrolizumab or nivolumab experience lasting clinical responses. The Hemopurifier has shown potential in preclinical studies to reduce exosome numbers in cancer patient plasma samples. The primary endpoint of the trial will be the incidence of adverse events and significant changes in safety lab tests.
The trial will enroll around 18 patients who, after a two-month period of anti-PD-1 monotherapy, will be eligible for Hemopurifier treatment. The study will explore the number of treatments needed to decrease EV concentrations and whether this leads to an improved immune response against tumor cells.
Aethlon's Chief Medical Officer, Steven LaRosa, MD, expressed optimism about the collaboration with Prof. Brown's team and the Contract Research Organizations involved. Plans are underway to activate a second site in Australia and to seek Ethics Committee approval for a site in India.
The Hemopurifier, which is also being developed for use in life-threatening viral infections and organ transplantation, has demonstrated the ability to remove harmful exosomes and viruses from biological fluids in human and preclinical studies.
This report is based on a press release statement from Aethlon Medical, Inc.
In other recent news, Aethlon Medical, Inc., a medical device company, has made strides in its research and development efforts. The company's Hemopurifier® has shown promise in a preclinical study, potentially improving outcomes of kidney transplants by removing harmful substances from preservation fluids. The study revealed a significant reduction in extracellular vesicles and microRNAs, entities associated with complications in kidney transplants.
On the financial front, Aethlon reported a cash balance of $9.1 million and a net loss of $2.6 million for the fiscal first quarter of 2025. The company continues to advance its Hemopurifier technology with a clinical trial set to begin in Australia for patients with solid tumors, and a COVID-19 trial in India. Operating expenses have decreased with further cost reductions planned, but expenses are projected to rise due to increased clinical trial activities in Australia.
In preparation for these trials, Aethlon is hiring for a technical position to support clinical trial sites. Despite the net loss, the firm maintains its focus on its potential to address significant health challenges, including pandemics like COVID-19. These are the recent developments for Aethlon Medical, Inc.
InvestingPro Insights
As Aethlon Medical, Inc. (NASDAQ:AEMD) embarks on a pivotal clinical trial for its Hemopurifier, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, AEMD holds a market capitalization of just $5.35 million USD, reflecting the small size of the company within the medical device industry. Despite the innovation behind the Hemopurifier, AEMD is not currently profitable, with an adjusted P/E ratio for the last twelve months as of Q1 2025 standing at -0.5. This indicates that investors are not expecting earnings to turn positive in the near term.
InvestingPro Tips suggest that AEMD is quickly burning through cash, which is a critical factor for a company in the midst of advancing clinical trials that require significant investment. Moreover, the company suffers from weak gross profit margins, which could impact its ability to achieve profitability in the foreseeable future. However, it's worth noting that AEMD holds more cash than debt on its balance sheet, which could provide some financial flexibility as it continues its research and development efforts.
The stock price of AEMD has been volatile, and the price has fallen significantly over the last year, with a one-year price total return as of the end of 2024 standing at -85.78%. This performance may raise concerns among investors about the company's ability to deliver value in the long term. For those considering an investment in AEMD, it's important to weigh these financial metrics and market performance data against the potential clinical impact of the Hemopurifier.
For more detailed analysis and additional InvestingPro Tips, investors can visit InvestingPro, which offers a comprehensive list of 13 additional tips to help inform investment decisions regarding Aethlon Medical, Inc.
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