By M. Marin
NASDAQ:AEMD
READ THE FULL AEMD RESEARCH REPORT
Approval from first two locations, with submissions planned to additional venues …
Yesterday Aethlon Medical (NASDAQ:AEMD) announced FY 1Q (quarter ended June 30, 2024) results and provided a business update. The company’s primary focus on researching the Hemopurifier® therapeutic blood filtration system as a potential treatment in oncology has had several recent milestones as AEMD moves forward to launch a basket oncology trial to study the impact of the Hemopurifier in patients with various solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment.
Unfortunately, currently, only about 30% of cancer patients who receive pembrolizumab or nivolumab treatment for solid tumors have lasting clinical responses. Aethlon intends to study whether the Hemopurifier, in conjunction with these agents, can improve outcomes for a higher percentage of patients. 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® or Opdivo® help to block the PD-1 pathway to prevent cancer cells from hiding and, in turn, help the immune system work. While these and other anti-PD-1 monotherapy treatments represent a substantial advance in cancer treatment, they do not work on the majority of cancer patients with certain tumor types.
AEMD believes it can generate data to support the Hemopurifier’s ability when combined with checkpoint inhibitor treatment to improve outcomes in multiple tumor types where cancer associated extracellular vesicles, or EVs, may promote immune suppression and resistance to anti-PD-1 antibodies. The Hemopurifier has demonstrated the ability to remove exosomes; management believes the device can be used to affect improved outcomes in a number of cancers. The device has received FDA Breakthrough Device designation for the treatment of people with advanced or metastatic cancer who are either unresponsive to or cannot tolerate standard of care therapy, and with cancer types in which exosomes are indicated in the development or severity of the disease (and also for life-threatening viruses that are not addressed with approved therapies).
Aethlon’s phase 1 safety, feasibility and dose-finding clinical trials of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment will be conducted in Australia and India. The company has received full ethics approval for the study from two Australian Ethics Committees.
Approval from Bellberry Human Research Ethics Committee to the Pindara Private Hospital
Earlier this week, Aethlon received full ethics approval from the Bellberry Human Research Ethics Committee (BHREC) to the Pindara Private Hospital for the safety, feasibility and dose-finding clinical trial. The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital in Queensland, Australia. This represents the second ethics committee approval AEMD has received in Australia for the oncology trial.
CALHN granted full ethics approval for safety, feasibility & dose-finding study
In June 2024, AEMD has received approval for the Hemopurifier® cancer trial from the ethics committee of the Central Adelaide Local Health Network (CALHN), which has granted full ethics approval for Aethlon’s safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment. This is an important step forward as the company continues to advance research and clinical development activities for the Hemopurifier.
Studying if Hemopurifier can help decrease concentration of EVs, improve overall patient outcomes…
In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. Participating patients will be assigned to one of three different cohorts: cohort 1 will receive one Hemopurifier treatment during a one-week period, cohort 2 will receive two treatments and cohort 3 will receive three treatments during a one-week period. Analysis of the data generated from this study will be used to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study to move toward regulatory approval.
Next steps include site visits, patient enrollments…
The next step is that the Research Governance Office at each hospital reviews insurance and indemnities. Once they provide approval that all necessary insurance, et.al. is in order, Aethlon will conduct Site Initiation Visits (SIVs) with its Australian Contract Research Organization (CRO), ReSQ. After that, the process of enrolling patients can begin. The company expects to begin the patient enrollment process in October 2024.
The company expects upcoming milestones to include the submission to the Ethics Committees at a third site in Australia and one in India, possible approval from one or both of those venues as early as the September or December 2024 quarter and the launch of the patient enrollment process at those venues by year-end 2024. We would expect AEMD to announce that the first patient has been treated possibly by year-end 2024 or early 205. Subsequently, we would expect AEMD to announce that it has received all the data from the first cohort of patients once the data has come through.
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