Aethlon Medical Reports Positive Results From an In Vitro Binding Study of Its Hemopurifier® in Removing Extracellular Vesicles From Cancer Patient Plasma

Rhea-AI Summary

Aethlon Medical, Inc. reported positive results from an in vitro binding study of its Hemopurifier® in removing extracellular vesicles (EVs) from cancer patient plasma. The study supports the design of a Phase 1 trial in cancer patients with solid tumors undergoing anti-PD-1 treatment. The Hemopurifier showed promise in reducing EVs from plasma, paving the way for upcoming clinical trials in Australia and India.

Positive

• The positive results from the in vitro binding study indicate the Hemopurifier's potential in removing extracellular vesicles from cancer patient plasma.

• The study provides pre-clinical evidence to support the design of a Phase 1 safety, feasibility, and dose-finding clinical trial for the Hemopurifier in patients with solid tumors under anti-PD-1 treatment.

• Aethlon Medical's successful translational study is a significant step forward in its oncology research and development efforts.

Negative

• None.

Insights

Medical Research Analyst

The findings presented by Aethlon Medical regarding their proprietary Hemopurifier's ability to remove extracellular vesicles (EVs) from cancer patient plasma could potentially be a noteworthy advancement in the treatment of cancer. By targeting EVs, which can contribute to tumor progression and drug resistance, the Hemopurifier might offer an adjunct therapy that improves the efficacy of existing treatments like anti-PD-1 antibodies. A critical aspect highlighted is the experimental setting's realism, as it mimics a clinical scenario more accurately than previous buffer solution tests. Nevertheless, it's worth noting the indication about the small number of EVs bearing PD-L1, which implies that further investigation is needed to understand the full clinical implications. For investors, the progression to phase 1 clinical trials is a pivotal milestone that can signal the company's advancement in the therapeutic area, but caution should be exercised given the early nature of the data and the long road to potential market approval.

Oncology Doctor

The utilization of Aethlon's Hemopurifier in the removal of extracellular vesicles (EVs) from the plasma of cancer patients marks a promising frontier in oncology. EVs have been implicated in various processes that promote malignancy, including enhancing tumor growth and contributing to immune evasion. If the Hemopurifier is shown to effectively deplete these vesicles, this could represent a significant tool in the management of solid tumors, particularly in conjunction with immune checkpoint inhibitors like anti-PD-1 therapies. However, the mention of inconclusive results regarding PD-L1 positive EV subset removal serves as a reminder of the complexity of cancer biology and the necessity for extensive clinical evaluation. This news should be carefully considered by investors as it represents both an opportunity and risk given the unpredictability inherent in early-stage clinical research.

Financial Analyst

Aethlon Medical’s announcement is poised to ignite investor interest due to its potential impact on the company's pipeline and future revenue streams. The transition from in vitro studies to phase 1 clinical trials is a significant step in the development process and is typically met with positive reception from the market. However, it is important to discern between initial excitement and viable, long-term investment potential. Financial backers should consider the costs associated with clinical trials, potential funding needs and the time frame for commercialization. Furthermore, the scalability of the Hemopurifier and its integration into existing treatment protocols will be fundamental in determining its market adoption and financial success. Investors would benefit from a cautious approach, monitoring forthcoming trial data for efficacy and safety outcomes that could solidify the Hemopurifier's value proposition in the oncology treatment landscape.

Translational Study Provides Pre-Clinical Evidence to Support The Design of a Phase 1 Study of the Hemopurifier In Cancer Patients With Solid Tumors Treated With Anti-PD-1 Antibodies

SAN DIEGO, May 10, 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 positive results from an in vitro binding study of its Hemopurifier® in removing extracellular vesicles (EVs) from plasma. The translational study provides pre-clinical evidence to support Aethlon's planned 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, such as Keytruda® or Opdivo®.

"The positive data from this in vitro binding study of the Hemopurifier is an important step forward for Aethlon, ahead of the potential start of our planned phase 1 oncology trials in Australia and India," stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "We have previously demonstrated that our Hemopurifier can reduce EVs isolated from cancer patient plasma when those EVs are placed in a buffer solution. However, ahead of our oncology study, we wanted to conduct a more robust translational study, specifically examining the removal of EVs and EVs with PD-L1 on their surface directly from plasma. To that end, we acquired small volumes of plasma from patients treated with anti-PD-1 antibodies from a third-party lab and ran the samples over a miniature version of our Hemopurifier. We then had the samples examined by Cellarcus Biosciences, Inc., an independent commercial lab with recognized expertise in EV quantification and phenotyping, by the widely accepted methodology of vesicle flow cytometry. This data was then analyzed by independent statisticians at NAMSA, the contract research organization (CRO) for our planned Australian oncology study."

Mr. Frakes concluded, "The descriptive statistics from the CRO support the removal of EVs by the Hemopurifier directly from cancer patient plasma, although the small numbers of EVs bearing PD-L1 did not allow us to conclude a removal of this particular EV subset. We look forward to adding this data to our Clinical Investigator Brochure and submitting it to the Ethics Committees at the interested clinical sites, as the next step for our planned phase 1 oncology trials in Australia and India."

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 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

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SOURCE Aethlon Medical, Inc.

FAQ

What did Aethlon Medical report from the in vitro binding study of the Hemopurifier®?

Aethlon Medical reported positive results from the in vitro binding study of its Hemopurifier® in removing extracellular vesicles (EVs) from cancer patient plasma.

What is the purpose of the translational study conducted by Aethlon Medical?

The translational study provides pre-clinical evidence to support the design of a Phase 1 safety, feasibility, and dose-finding clinical trial for the Hemopurifier in cancer patients with solid tumors treated with anti-PD-1 antibodies.

Where are Aethlon Medical's planned phase 1 oncology trials set to take place?

Aethlon Medical's planned phase 1 oncology trials are expected to take place in Australia and India.

Who is the Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical?

James Frakes is the Interim Chief Executive Officer and Chief Financial Officer of Aethlon Medical.

What methodology was used to analyze the data from the in vitro binding study?

The data from the in vitro binding study was analyzed by Cellarcus Biosciences, Inc. using the methodology of vesicle flow cytometry.