Aethlon Medical, Inc. Announces Positive Data Safety Monitoring Board Review and Recommendation to Advance to Next Clinical Trial Cohort
Rhea-AI Summary
Aethlon Medical (Nasdaq: AEMD) announced positive safety review results from the independent Data Safety Monitoring Board (DSMB) for its ongoing clinical trial AEMD-2022-06 of the Aethlon Hemopurifier®. The trial is evaluating the device's safety and optimal dosing in cancer patients with stable or progressive disease while on Pembrolizumab or Nivolumab treatment.
The DSMB reviewed data from the initial three-patient cohort, who each received a single 4-hour Hemopurifier treatment, finding no safety concerns or serious adverse events. The board recommended advancing to Cohort 2, where participants will receive two Hemopurifier treatments over one week. The trial aims to enroll 9-18 patients across three Australian clinical sites.
The study targets patients among the 60-70% who don't respond well to anti-PD-1 immunotherapy, with findings intended to inform future Premarket Approval studies.
Positive
- None.
Negative
- Early-stage trial focused only on safety and dosing, not yet proving efficacy
- Small initial cohort size of only three patients
- Full trial size remains relatively small at 9-18 patients
- Multiple future trials still required before potential market approval
News Market Reaction – AEMD
On the day this news was published, AEMD gained 4.35%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.5% during that session. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $130K to the company's valuation, bringing the market cap to $3M at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
The trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab", is being conducted to assess the Hemopurifier's safety, feasibility, and optimal dosing.
The DSMB- comprising independent medical experts in nephrology and oncology- reviewed data from the initial cohort of three participants, each of whom received a single 4-hour Hemopurifier treatment. Based on their evaluation, the board found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported.
"The DSMB's positive recommendation is encouraging and underscores the favorable safety profile observed to date in patients with cancer," according to Steven LaRosa, M.D, Chief Medical Officer of Aethlon Medical. "This marks a significant step forward in the clinical development program for the Hemopurifier in Oncology and brings the company closer to potentially addressing the significant unmet medical need for the approximately 60
Enrollment for Cohort 2 is now open. In this phase, participants will receive two Hemopurifier treatments over a one-week period at the study's three active clinical sites in
The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier- treated patients. In addition to safety monitoring, 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 findings are expected to inform the design of a future efficacy and safety, Premarket Approval (PMA), study required by regulatory authorities.
Aethlon Medical, Inc. remains committed to advancing the Hemopurifier for use in oncology and will continue to provide updates as the clinical trial progresses.
About the Hemopurifier®
The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles (EVs) from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects.
The Hemopurifier holds a
- The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and
- The treatment of life-threatening viruses not addressed with approved therapies.
The Hemopurifier is being developed under an open Investigational Device Exemption (IDE) for both indications.
About Aethlon Medical, Inc.
Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinical stage medical device company headquartered in
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 include, without limitation, the number of patients who receive pembrolizumab or nivolumab that will have lasting clinical responses to these agents; device deficiencies or immediate complications; the possibility of novel treatment strategies; how the Hemopurifier may reduce tumor-derived extracellular vesicles and enhance T cell activity against tumors; the efficacy of continued clinical trials; development under IDE for indications; and/or the number of patients enrolled in each cohort. 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, 2024, 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
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 did the DSMB review reveal about Aethlon Medical's (AEMD) Hemopurifier trial?
How many patients will be enrolled in Aethlon Medical's (AEMD) Hemopurifier cancer trial?
What is the treatment protocol for Cohort 2 in AEMD's Hemopurifier trial?
What patient population is Aethlon Medical's (AEMD) Hemopurifier targeting?
What are the primary endpoints of AEMD's current Hemopurifier clinical trial?
