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Aethlon Medical Prepares for Potentially Transformative Phase 1 Cancer Treatment Studies

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Aethlon Medical is advancing its phase 1 clinical trials for the Hemopurifier®, aimed at patients with solid tumors unresponsive to anti-PD-1 treatments like Keytruda® or Opdivo®.

Progress includes the integration of new in vitro data showing exosome removal from cancer patient plasma, which has been included in documentation for Ethics Committees. Submissions have been made to Ethics Boards in Australia and India, with one site already submitting on May 24, 2024.

Once approvals are received, Clinical Trial Agreements will be finalized, and patient recruitment can begin. The trials focus on safety, feasibility, and dose-finding.

Positive
  • Progress in phase 1 trials for Hemopurifier® aimed at solid tumors unresponsive to anti-PD-1 treatments.
  • New in vitro data shows successful exosome removal from cancer patient plasma.
  • Documentation has been submitted to Ethics Boards in Australia and India.
  • One site has already submitted documents to its Ethics Board on May 24, 2024.
  • Next steps include finalizing Clinical Trial Agreements and starting patient recruitment.
Negative
  • Pending Ethics Committee approvals which could delay trial initiation.
  • Potential risk if Ethics Committees reject or delay approval of trial documentation.
  • Challenges in recruiting patients who fit the specific criteria for the study.

Aethlon Medical's upcoming phase 1 trials for their Hemopurifier® target a critical patient population: those with solid tumors not responding to established anti-PD-1 immunotherapies like Keytruda® or Opdivo®. This group represents a significant unmet medical need. These trials could provide a new treatment option if successful, addressing a niche but important segment of oncology patients.

The focus on ethics committee submissions indicates that the company is still in the preparatory phase. Results from phase 1 trials typically assess safety and dosage, rather than efficacy, meaning substantial progress is still required before commercial viability. While this is an important step, it's a long journey towards regulatory approval and market adoption.

It's essential to understand that early-stage trials often face high failure rates. Therefore, while the scientific premise is intriguing, investors should temper expectations with the reality of clinical trial risks.

The financial implications of Aethlon Medical's announcement are mixed. On one hand, progressing to phase 1 trials can be seen as a milestone that could potentially unlock future value. On the other hand, these updates are preliminary and suggest that significant revenue generation is still distant. Early-phase clinical trials are capital intensive with uncertain outcomes.

Investors might also consider the company's current cash burn rate and funding needs. Given the nature of biotechnology ventures, Aethlon may require additional capital raises, which could dilute existing shareholders. Furthermore, the narrow focus on a specific cohort of cancer patients means that the market opportunity, while potentially valuable, is also limited in scope compared to broader oncology treatments.

Therefore, while the news is a step forward, it does not fundamentally alter the company's current financial outlook, which remains speculative and dependent on successful trial outcomes.

From a clinical perspective, Aethlon Medical’s Hemopurifier® presents an innovative approach by targeting exosome removal in cancer patients, particularly those who have not responded to anti-PD-1 therapies. Exosomes play a role in cancer progression and immune evasion, making them a novel target for therapeutic intervention.

However, the transition from in vitro data to clinical efficacy is substantial. Oncology treatments require rigorous validation in clinical settings to ensure not only safety but also therapeutic benefit. Phase 1 trials focusing on safety and dosage are just the initial steps. Subsequent phases will need to demonstrate significant clinical benefit for the Hemopurifier® to become a part of standard oncology treatment protocols.

For retail investors, it's important to note that while the scientific concept is promising, the path to clinical success is challenging and protracted. Continuous updates on clinical trial progress will be critical in evaluating the true potential of this treatment.

Phase 1 Clinical Trials of the Hemopurifier® Designed to Include Patients With Solid Tumors Who Have Stable or Progressive Disease During Anti-PD-1 Monotherapy Treatment, Such as Keytruda® of Opdivo®

Interested Clinical Sites Have Initiated Submissions For Ethics Committee Review

SAN DIEGO, June 3, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today provided the following update on its planned phase 1 safety, feasibility and dose-finding clinical trials of its Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

"We continue to make progress preparing for our planned, safety, feasibility and "dose finding" oncology trials in Australia and India, and want to provide our shareholders and other constituents with an update, stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. In early May, we announced new data showing the in vitro removal of exosomes from cancer patient plasma using a miniature version of our Hemopurifier®. This data has been quickly integrated into the required documentation for Ethics Committees at our potential clinical sites. On May 17, 2024, we provided these documents to the Contract Research Organizations for these planned clinical trials. Subsequently, on May 24, 2024, one potential site submitted the documents to its Ethics Board.  An additional site in Australia and another in India are currently assembling the packages for submission to their Ethics Committees.

Once we receive the expected Ethics Committee approvals, we will finalize the Clinical Trial Agreements. After this, hospitals can begin recruiting patients for the trials.

As a reminder, the target patient population for these safety, feasibility, and dose finding trials is oncology patients with solid tumors who are failing their anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

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 the approval by the 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
917-513-5303

Cision View original content:https://www.prnewswire.com/news-releases/aethlon-medical-prepares-for-potentially-transformative-phase-1-cancer-treatment-studies-302161637.html

SOURCE Aethlon Medical, Inc.

FAQ

What is the focus of Aethlon Medical's phase 1 clinical trials?

The trials focus on the Hemopurifier® for patients with solid tumors unresponsive to anti-PD-1 treatments like Keytruda® or Opdivo®.

What new data did Aethlon Medical recently announce?

They announced new in vitro data showing the removal of exosomes from cancer patient plasma using a miniature version of the Hemopurifier®.

When were the trial documents submitted to the Ethics Board?

One potential site submitted the documents to its Ethics Board on May 24, 2024.

What are the next steps after receiving Ethics Committee approvals?

Clinical Trial Agreements will be finalized and patient recruitment can begin.

Where are the phase 1 trials for the Hemopurifier® planned?

The trials are planned in Australia and India.

Aethlon Medical, Inc.

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Analytical Laboratory Instrument Manufacturing
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SAN DIEGO