SAN DIEGO - Aethlon Medical, Inc. (NASDAQ:AEMD), a medical therapeutic company, announced today that it has received full ethics approval from the Medanta Institutional Ethics Committee (MIEC) for a clinical trial involving its Hemopurifier device in cancer patients. The trial will focus on the safety, feasibility, and dosage of the Hemopurifier in patients with solid tumors who have not responded to anti-PD-1 antibody treatments, such as Keytruda (pembrolizumab) or Opdivo (nivolumab).
This approval, granted on September 9, 2024, follows previous ethics committee approvals in Australia and allows the trial to commence with patient recruitment expected to begin in the fourth calendar quarter of this year. The study will be conducted under the supervision of Dr. Ashok K. Vaid at Medanta Medicity Hospital's Department of Medical Oncology and Hematology in Gurugram, India, with Dr. Puneet Sodhi leading the Hemopurifier treatments.
The Hemopurifier is a clinical stage immunotherapeutic device designed to remove extracellular vesicles (EVs) from the bloodstream. EVs have been implicated in resistance to anti-PD-1 therapies and in the spread of cancer. Approximately 30% of cancer patients treated with pembrolizumab or nivolumab for solid tumors achieve lasting clinical responses. The device aims to improve response rates by reducing the number of EVs, potentially enhancing the body's natural ability to combat tumor cells.
The trial will enroll roughly nine to 18 patients and will evaluate the safety of the Hemopurifier over different treatment intervals following a two-month run-in period with PD-1 antibody monotherapy. The study will also assess the number of treatments required to decrease EV concentrations and whether these changes can augment the body's immune response against tumors.
Aethlon's Hemopurifier has received a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the treatment of individuals with advanced or metastatic cancer unresponsive to standard therapy, and for organ transplantation use. It also holds an FDA Breakthrough Device designation for the treatment of life-threatening viruses not addressed with approved therapies.
This press release statement serves as the basis for the facts reported in this article.
In other recent news, Aethlon Medical, Inc. has made significant strides in their research and development efforts. The company's Hemopurifier has shown promise in a preclinical study, potentially improving kidney transplant outcomes by removing harmful substances. Concurrently, Aethlon has also begun patient enrollment at the Royal Adelaide Hospital for a clinical trial of the Hemopurifier in patients with solid tumors.
In terms of financials, the company reported a cash balance of $9.1 million and a net loss of $2.6 million for the fiscal first quarter of 2025. Despite the net loss, Aethlon continues to advance its Hemopurifier technology with increased clinical trial activities in Australia anticipated to raise expenses.
These recent developments highlight Aethlon's commitment to their research and the potential of the Hemopurifier to address significant health challenges. The company is also preparing for increased clinical trial activities in Australia and is in the process of hiring for a technical position to support these sites. Despite the financial loss, the company remains focused on its potential to address significant health challenges, including pandemics like COVID-19.
InvestingPro Insights
Aethlon Medical, Inc. (NASDAQ:AEMD) has reached a pivotal moment with the full ethics approval for its Hemopurifier clinical trial in India. As the company prepares to advance its therapeutic device, it's important for investors to consider the financial health and market performance of AEMD. According to InvestingPro, Aethlon Medical holds more cash than debt on its balance sheet, which may provide some financial flexibility as they embark on this new trial phase. However, the company is quickly burning through cash, which could potentially impact its ability to fund ongoing and future research activities.
InvestingPro Data shows that Aethlon Medical has a market capitalization of 5 million USD, indicating a relatively small player in the biotech sector. The company's stock price has been quite volatile, with significant declines over various timeframes. Over the last week, month, three months, six months, and year, the stock has experienced total price returns of -9.04%, -22.59%, -46.9%, -78.15%, and -85.81%, respectively. These figures suggest that investor confidence may be waning or that the market is reacting to the inherent risks of clinical trials and product development in the biotech industry.
Furthermore, analysts do not anticipate Aethlon Medical will be profitable this year, as evidenced by a negative P/E ratio of -0.12. This aligns with the fact that the company has not been profitable over the last twelve months. The InvestingPro platform features additional tips and metrics for AEMD, including insights on valuation, liquidity, and stock price performance over longer periods, which can provide investors with a more comprehensive understanding of the company's financial position.
For investors interested in a deeper dive into Aethlon Medical's financials and market performance, there are 16 additional InvestingPro Tips available at https://www.investing.com/pro/AEMD. These tips could offer valuable perspectives for those considering an investment in the company as it progresses with its Hemopurifier clinical trials.
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