By M. Marin
NASDAQ:AEMD
READ THE FULL AEMD RESEARCH REPORT
Next step: AEMD will submit cumulative data to sites interested in participating in its oncology study…
Aethlon Medical (NASDAQ:AEMD) reported positive data from an in vitro binding study it had implemented of the potential for the Hemopurifier® to remove extracellular vesicles (EVs) directly from plasma of cancer patients. The data supports moving forward with Aethlon’s planned phase 1 clinical trials in Australia and India of the Hemopurifier in cancer patients and, importantly, enables the company to submit findings to medical sites interested in participating in the study. The Hemopurifier®, a therapeutic blood filtration system that can bind and remove harmful particles from blood, has shown it can remove extracellular vesicles (EVs) directly from cancer patient plasma. In recent months, the company has increased its focus on advancing the Hemopurifier as a potential treatment in oncology.
We expect AEMD to submit its Clinical Investigator Brochure, including in vitro data, this month
The data from this in vitro study is a critical element enabling the company to move the Hemopurifier forward in clinical oncology studies towards potential regulatory approval and commercialization. The company next intends to add this data to its Clinical Investigator Brochure, which will then be submitted to the Ethics Committees at clinical sites that are interested in participating in the planned phase 1 oncology trials in Australia and India. We expect AEMD to submit the Clinical Investigator Brochure this month.
AEMD will then seek to obtain approval by the respective Ethics Boards of interested sites in India. The company has a strong clinical working relationship with Medanta Medicity Hospital in Delhi, India, which is currently participating in a study of the Hemopurifier in COVID patients and it would not surprise us if Medanta Medicity Hospital had interest in participating in the oncology study.
Depending on how long it takes for the sites to review and potentially approve moving forward to participate in Aethlon’s phase 1 trial, we believe clinical efforts could begin in 2H24. If Aethlon can demonstrate the ability of the Hemopurifier to improve outcomes of cancer patients suffering from a variety of different cancer types, we would anticipate strong commercial prospects for the Hemopurifier. The company received clearance from the Drug Controller General of India (DCGI – India’s central drug authority) in late 2023 to conduct a phase 1 safety, feasibility and dose-finding trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment such as Keytruda® or Opdivo®. PD-1, or Programmed Cell Death Protein 1, is a protein found on the cell surface that plays a role in inhibiting immune responses. Treatment such as Keytruda®, a type of immunotherapy, helps to block the PD-1 pathway to prevent cancer cells from hiding and, in turn, help the immune system work. While Keytruda® and other anti-PD-1 monotherapy treatments represent a substantial advance in cancer treatment, with certain tumor types it does not work on the majority of cancer patients.
Potentially boosting effectiveness of checkpoint inhibitors to improve overall patient outcomes
Despite the many benefits of checkpoint inhibitors, unfortunately only a minority of patients respond positively to the treatment. For example, according to NIH, “Pembrolizumab (Keytruda® is the brand name) has provided a new first-line option for patients with advanced NSCLC (Non-Small Cell Lung Cancer) and patients can achieve sustained remission once they respond to it, but less than 30% of patients will respond to pembrolizumab.”
That means that the majority of patients do not respond to checkpoint inhibitors. Aethlon expects the Hemopurifier, in conjunction with an inhibitor, can help improve overall patient outcomes and demonstrate proof of concept about the device’s benefits in treating solid tumors.
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