Aethlon Medical Receives Ethics Committee Approval for Hemopurifier® Cancer Trial

Rhea-AI Summary

Aethlon Medical received ethics approval from the Human Research Ethics Committee of the Central Adelaide Local Health Network for its Hemopurifier® cancer trial. The trial, focusing on safety, feasibility, and dose-finding, targets cancer patients with solid tumors unresponsive to anti-PD-1 antibodies. Conducted by Prof. Michael Brown's team in Adelaide, Australia, the study aims to reduce extracellular vesicles to improve therapeutic responses. The approval is valid until June 13, 2027. The primary endpoint is safety, with patient enrollment following a two-month PD-1 antibody monotherapy period. Aethlon plans to seek additional approvals in Australia and India.

Positive

• Full ethics approval from the Human Research Ethics Committee of the Central Adelaide Local Health Network.
• The trial targets cancer patients with solid tumors unresponsive to anti-PD-1 antibodies, addressing a significant unmet medical need.
• The approval is valid until June 13, 2027, providing a stable timeframe for trial completion.
• The Hemopurifier® aims to improve therapeutic responses by reducing extracellular vesicles implicated in cancer spread and resistance.
• The trial will be conducted at the reputable Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital.
• Aethlon plans to submit for additional ethics approvals in other sites in Australia and India, potentially expanding the trial's reach.
• Involvement of experienced professionals like Prof. Michael Brown and collaboration with established CROs NAMSA and ReSQ Clinical Research.

Negative

• The primary endpoint is safety, which may not provide immediate efficacy results important for investor confidence.
• The study focuses on exploratory analyses, meaning definitive efficacy data will not be available until subsequent trials.
• The trial's success depends on approval from the Therapeutic Goods Administration and CALHN Research Governance Committee, adding regulatory uncertainties.
• Potential delays in patient enrollment due to the multiple steps involved post-ethics approval.
• The trial involves only approximately 18 patients, which may limit the generalizability of the results.

Insights

Oncology Doctor

The approval of the Hemopurifier® trial by the Human Research Ethics Committee represents a noteworthy advancement in the field of oncology. The Hemopurifier® is designed to remove extracellular vesicles (EVs), which are implicated in both the spread of cancer and resistance to existing anti-PD-1 therapies like pembrolizumab and nivolumab. This trial could be particularly significant for the roughly 70% of patients whose tumors do not respond to these therapies.

For oncology professionals, the potential to improve response rates in these patients by targeting EVs is intriguing. This approach addresses a critical unmet need in cancer treatment, as current therapies often fail to provide lasting responses for a significant portion of patients. If successful, this could pave the way for new combination treatments that enhance the efficacy of existing immunotherapies.

The study's primary focus on safety, with secondary measures analyzing the reduction of EVs and their impact on the body's immune response, will provide valuable insights. This information could guide future clinical practices and regulatory approvals. Retail investors should view this development as a positive indicator of the company's innovative approach and commitment to addressing key challenges in cancer therapy.

Medical Research Analyst

From a medical research perspective, the approval for the Hemopurifier® trial is a promising step forward. Conducted at the Royal Adelaide Hospital, the study aims to evaluate safety, feasibility and optimal dosing in a clinical setting. This is important because it transitions the Hemopurifier from preclinical studies, where it showed potential in reducing exosomes, to a real-world patient environment.

The trial's design, which includes patients with stable or progressive disease during PD-1 therapy, is strategically sound. These patients are an ideal target group to explore the Hemopurifier's effectiveness, as their current treatment options are limited. The rigorous monitoring of safety and adverse events is standard but necessary to ensure patient well-being.

The exploratory analyses focusing on EV concentrations could provide critical data that informs the design of a subsequent efficacy and safety study. This stage is important for regulatory approval processes and the eventual market introduction of the Hemopurifier. For investors, this trial represents a calculated risk with potential high reward, contingent on successful outcomes.

Aethlon Medical Granted Full Ethics Approval From the Human Research Ethics Committee at Central Adelaide Local Health Network for a Safety, Feasibility, and Dose Finding Study of its Hemopurifier® in Cancer Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies

SAN DIEGO, June 18, 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, on June, 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) 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, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for three years, until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.

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 approval from the Human Research Ethics Committee at Central Adelaide Local Health Network marks a significant milestone for Aethlon, as they deemed that our clinical study meets the requirements of the Australia's National Statement on Ethical Conduct in Human Research," 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, NAMSA and ReSQ Clinical Research. The next steps include submission to the Therapeutic Goods Administration, the national health regulatory agency of Australia, obtaining approval from the CALHN Research Governance Committee, and conducting a site initiation visit to facilitate patient enrollment. Following this Ethics Board approval, we plan to submit to the Ethics Committees at two additional sites in Australia and one in India."

The primary endpoint of the approximate 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in 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 if 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 work with the requisite personnel and complete the next steps to facilitate patient enrollment, the Company's ability to submit additional studies and obtain the approval by the additional respective Ethics Boards of interested clinical trial sites in India and in Australia, the Company's ability to recruit patients for and manage its clinical trials, 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

View original content:https://www.prnewswire.com/news-releases/aethlon-medical-receives-ethics-committee-approval-for-hemopurifier-cancer-trial-302175092.html

SOURCE Aethlon Medical, Inc.

FAQ

What is Aethlon Medical's new trial about?

Aethlon Medical's new trial focuses on the safety, feasibility, and dose-finding of the Hemopurifier® in cancer patients with solid tumors unresponsive to anti-PD-1 antibodies.

When did Aethlon Medical receive ethics approval for their Hemopurifier® trial?

Aethlon Medical received ethics approval on June 13, 2024.

Where will Aethlon Medical's Hemopurifier® trial be conducted?

The trial will be conducted at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Adelaide, Australia.

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

The primary endpoint of the trial is safety.

What is the duration of the ethics approval for Aethlon Medical's Hemopurifier® trial?

The ethics approval is valid until June 13, 2027.

What is the expected patient population for Aethlon Medical's Hemopurifier® trial?

The trial targets cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment.

What are the next steps for Aethlon Medical after receiving ethics approval?

The next steps include submission to the Therapeutic Goods Administration, obtaining approval from CALHN Research Governance Committee, and conducting a site initiation visit.

How many patients will be involved in Aethlon Medical's Hemopurifier® trial?

The trial will involve approximately 18 patients.