Aethlon Medical Receives Ethics Board Approval to Add Second Site to its Ongoing Clinical Trial of its Hemopurifier® to Treat Severe COVID-19 in India
SAN DIEGO, May 22, 2023 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today announced that it has received Ethics Review Board (ERB) approval from the Maulana Azad Medical College (MAMC), for a second site for its ongoing clinical trial of Aethlon's Hemopurifier® to treat severe COVID-19 in India.
MAMC was established in 1958 and is located in New Delhi, India. MAMC is affiliated with the University of Delhi and is operated by the Delhi government.
"Cases of COVID-19 infection that require hospitalization continue to occur in India. The addition of MAMC as a second high quality clinical site may improve our enrollment of patients who go on to require ICU care for severe infection," commented Steven LaRosa, M.D., Chief Medical Officer of Aethlon Medical.
Aethlon Medical's clinical trial of the Hemopurifier in patients with SARS-CoV-2, or COVID-19, in the ICU with severe or life-threatening disease, is designed to enroll up to 15 patients at up to three centers throughout India. The initial site for the ongoing trial is Medanta Medicity Hospital in Gurgaon, India, and currently remains open for enrollment, with one patient treated to date.
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. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and harmful exosomes from blood 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.
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 enroll patients in its clinical trials in India, the Company's ability to obtain FDA approval of its new GNA supplier in a timely manner, the Company's ability to successfully treat patients under any Emergency Use pathway, the Company's ability to successfully complete development of its Hemopurifier, the Company's ability to raise additional funds, and the Company's ability expand its clinical trials into other areas of cancer, 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, 2022, 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.
Chief Financial Officer
Aethlon Medical, Inc.
S.A. Noonan Communications, LLC
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SOURCE Aethlon Medical, Inc.
Released May 22, 2023