SAN DIEGO – Aethlon Medical, Inc. (NASDAQ:AEMD), a medical therapeutic firm, introduced at this time that it has acquired full ethics approval from the Medanta Institutional Ethics Committee (MIEC) for a scientific trial involving its Hemopurifier machine in most cancers sufferers. The trial will deal with the protection, feasibility, and dosage of the Hemopurifier in sufferers with stable tumors who haven’t responded to anti-PD-1 antibody therapies, similar to Keytruda (pembrolizumab) or Opdivo (nivolumab).
This approval, granted on September 9, 2024, follows earlier ethics committee approvals in Australia and permits the trial to start with affected person recruitment anticipated to start within the fourth calendar quarter of this 12 months. The research might be performed below the supervision of Dr. Ashok Ok. Vaid at Medanta Medicity Hospital’s Division of Medical Oncology and Hematology in Gurugram, India, with Dr. Puneet Sodhi main the Hemopurifier therapies.
The Hemopurifier is a scientific stage immunotherapeutic machine designed to take away extracellular vesicles (EVs) from the bloodstream. EVs have been implicated in resistance to anti-PD-1 therapies and within the unfold of most cancers. Roughly 30% of most cancers sufferers handled with pembrolizumab or nivolumab for stable tumors obtain lasting scientific responses. The machine goals to enhance response charges by lowering the variety of EVs, probably enhancing the physique’s pure potential to fight tumor cells.
The trial will enroll roughly 9 to 18 sufferers and can consider the protection of the Hemopurifier over totally different therapy intervals following a two-month run-in interval with PD-1 antibody monotherapy. The research can even assess the variety of therapies required to lower EV concentrations and whether or not these modifications can increase the physique’s immune response towards tumors.
Aethlon’s Hemopurifier has acquired a Breakthrough Machine designation from the U.S. Meals and Drug Administration (FDA) for the therapy of people with superior or metastatic most cancers unresponsive to plain remedy, and for organ transplantation use. It additionally holds an FDA Breakthrough Machine designation for the therapy of life-threatening viruses not addressed with authorized therapies.
This press launch assertion serves as the idea for the info reported on this article.
In different current information, Aethlon Medical, Inc. has made vital strides of their analysis and growth efforts. The corporate’s Hemopurifier has proven promise in a preclinical research, probably enhancing kidney transplant outcomes by eradicating dangerous substances. Concurrently, Aethlon has additionally begun affected person enrollment on the Royal Adelaide Hospital for a scientific trial of the Hemopurifier in sufferers with stable tumors.
By way of financials, the corporate reported a money steadiness of $9.1 million and a web lack of $2.6 million for the fiscal first quarter of 2025. Regardless of the online loss, Aethlon continues to advance its Hemopurifier know-how with elevated scientific trial actions in Australia anticipated to boost bills.
These current developments spotlight Aethlon’s dedication to their analysis and the potential of the Hemopurifier to handle vital well being challenges. The corporate can also be making ready for elevated scientific trial actions in Australia and is within the technique of hiring for a technical place to help these websites. Regardless of the monetary loss, the corporate stays centered on its potential to handle vital well being challenges, together with pandemics like COVID-19.
InvestingPro Insights
Aethlon Medical, Inc. (NASDAQ:AEMD) has reached a pivotal second with the complete ethics approval for its Hemopurifier scientific trial in India. As the corporate prepares to advance its therapeutic machine, it is necessary for traders to contemplate the monetary well being and market efficiency of AEMD. In accordance with InvestingPro, Aethlon Medical holds more money than debt on its steadiness sheet, which can present some monetary flexibility as they embark on this new trial section. Nevertheless, the corporate is shortly burning by way of money, which may probably influence its potential to fund ongoing and future analysis actions.
InvestingPro Knowledge reveals that Aethlon Medical has a market capitalization of 5 million USD, indicating a comparatively small participant within the biotech sector. The corporate’s inventory worth has been fairly unstable, with vital declines over varied timeframes. During the last week, month, three months, six months, and 12 months, the inventory has skilled complete worth returns of -9.04%, -22.59%, -46.9%, -78.15%, and -85.81%, respectively. These figures recommend that investor confidence could also be waning or that the market is reacting to the inherent dangers of scientific trials and product growth within the biotech business.
Moreover, analysts don’t anticipate Aethlon Medical might be worthwhile this 12 months, as evidenced by a detrimental P/E ratio of -0.12. This aligns with the truth that the corporate has not been worthwhile over the past twelve months. The InvestingPro platform options extra ideas and metrics for AEMD, together with insights on valuation, liquidity, and inventory worth efficiency over longer durations, which may present traders with a extra complete understanding of the corporate’s monetary place.
For traders fascinated about a deeper dive into Aethlon Medical’s financials and market efficiency, there are 16 extra InvestingPro Suggestions accessible at https://www.investing.com/professional/AEMD. The following pointers may provide worthwhile views for these contemplating an funding within the firm because it progresses with its Hemopurifier scientific trials.
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