Aethlon Medical Announces Activation of Royal Adelaide Hospital to Begin Patient Screening and Enrollment in Hemopurifier® Cancer Trial

Rhea-AI Summary

Aethlon Medical (Nasdaq: AEMD) has announced the activation of the Cancer Clinical Trial Unit at Royal Adelaide Hospital to begin screening and enrolling patients for its Hemopurifier® clinical trial. The trial, focusing on patients with solid tumors not responding to anti-PD-1 antibodies, aims to assess safety, feasibility, and dosing of the Hemopurifier®.

Key points:

• Trial activation date: September 10, 2024
• Led by Prof. Michael Brown at Royal Adelaide Hospital, Australia
• Approximately 18 patients expected to participate
• Primary endpoint: Incidence of adverse events and safety lab changes
• Hemopurifier® designed to remove tumor-produced extracellular vesicles (EVs)
• Potential to improve response rates to anti-PD-1 therapies

Positive

• Activation of the first clinical trial site for the Hemopurifier® cancer study
• Potential to improve response rates to anti-PD-1 therapies, which currently have only 30% lasting clinical responses
• Plans to activate a second site in Australia and receive approval for a site in India, expanding the study's reach

Negative

• The trial is still in early stages, focusing on safety and feasibility rather than efficacy
• patient pool of approximately 18 participants
• Multiple regulatory approvals and steps required before full-scale efficacy studies can begin

Medical Research Analyst

The activation of Royal Adelaide Hospital for Aethlon Medical's Hemopurifier® trial is a significant development in cancer immunotherapy research. This study targets a critical gap in current anti-PD-1 therapies, which have efficacy in about 70% of patients. The Hemopurifier's unique approach of removing tumor-derived extracellular vesicles (EVs) could potentially enhance the effectiveness of existing immunotherapies.

The trial's design, focusing on safety, feasibility and dose-finding, is important for establishing the Hemopurifier's clinical potential. The staged approach with different treatment intervals will provide valuable insights into the optimal dosing regimen. Moreover, the exploratory analyses on EV concentrations and their impact on anti-tumor responses could pave the way for a new paradigm in combination cancer therapies.

Oncology Doctor

This trial represents a novel approach to overcoming resistance to anti-PD-1 therapies, a significant challenge in oncology. The Hemopurifier's mechanism of action, targeting EVs, addresses a key pathway in tumor immune evasion that current therapies don't target directly. If successful, this could offer a new option for patients who don't respond to standard immunotherapies.

The study's design, including a run-in period with anti-PD-1 monotherapy, is clinically relevant and will help isolate the Hemopurifier's effects. However, with only 18 patients and no control arm, this trial is primarily exploratory. The real test will be in subsequent larger, controlled studies. Nevertheless, this initial data will be important for optimizing treatment protocols and understanding the Hemopurifier's potential role in cancer care.

Market Research Analyst

The activation of this trial site is a positive step for Aethlon Medical, potentially accelerating their path to market. The immunotherapy market, valued at $85.1 billion in 2023, is projected to reach $277.1 billion by 2030. With the limitations of current anti-PD-1 therapies, there's significant market potential for complementary treatments like the Hemopurifier.

However, investors should note that this is an early-stage trial and regulatory approval is still distant. The company's plan to activate a second Australian site and expand to India shows strategic thinking in accelerating development. If successful, the Hemopurifier could position Aethlon as a key player in the growing field of combination cancer therapies. Yet, with a market cap of around $30 million, Aethlon faces significant challenges in funding further development and potential commercialization.

Aethlon's Trial is a Safety, Feasibility, and Dose Finding Study of the Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies

SAN DIEGO, Sept. 16, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced that the Cancer Clinical Trial Unit at Royal Adelaide Hospital was activated on September 10, 2024 to begin screening and enrolling patients in its safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia.

The activation follows the previously announced approval by the Human Research Ethics Committee at Central Adelaide Local Health Network on June 13, 2024, and the Research Governance office at Royal Adelaide Hospital, on September, 3 2024, as well as the notification of the Therapeutic Good Administration (TGA) and completion of a Site Initiation Visit on September 9, 2024.

"The activation of the investigative site at the Royal Adelaide Hospital marks a significant milestone for Aethlon, allowing the site to screen and enroll patients in this important clinical trial," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We look forward to working closely with Prof. Brown and his staff, and with our Contract Research Organizations (CROs), NAMSA and ReSQ Clinical Research, to begin enrollment and data collection. Going forward, we plan to activate a second site in Australia and also expect to receive an Ethics Committee approval for a clinical site in India."

Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.

The primary endpoint of the approximately 18-patient, safety, feasibility and dose-finding trial is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and whether these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.

About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

Additional information can be found at www.AethlonMedical.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to successfully complete development of the Hemopurifier and to successfully demonstrate the utility of the Hemopurifier in patients with solid tumors in our planned oncology clinical trials, the Company's ability to obtain Ethics Committee approval for a clinical site in India, the Company's ability to activate a second site in Australia, the Company's ability to recruit and enroll patients for and manage its clinical trials at the Royal Adelaide Hospital and other site locations, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2023, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Company Contact:
Jim Frakes
Interim Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com

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SOURCE Aethlon Medical, Inc.

FAQ

What is the purpose of Aethlon Medical's Hemopurifier® cancer trial?

The trial aims to assess the safety, feasibility, and dosing 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®.

When was the Royal Adelaide Hospital activated for Aethlon Medical's AEMD cancer trial?

The Cancer Clinical Trial Unit at Royal Adelaide Hospital was activated on September 10, 2024, to begin screening and enrolling patients for Aethlon Medical's Hemopurifier® cancer trial.

How many patients are expected to participate in Aethlon Medical's AEMD Hemopurifier® cancer trial?

The trial is expected to include approximately 18 patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment.

What is the primary endpoint of Aethlon Medical's AEMD Hemopurifier® cancer trial?

The primary endpoint is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients at different treatment intervals.

How does Aethlon Medical's Hemopurifier® potentially improve cancer treatment?

The Hemopurifier® is designed to bind and remove tumor-produced extracellular vesicles (EVs) from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies used in cancer treatment.