SAN DIEGO, Oct. 12, 2021 /PRNewswire/ -- Aethlon Medical,
Inc. (Nasdaq: AEMD), a company developing medical technology to
treat cancer and life-threatening infectious disease, today
announced the publication of a manuscript in the peer-reviewed
journal Frontiers in Medicine describing two cases of
critically ill COVID-19 patients treated with the Hemopurifier®,
Aethlon's therapeutic blood filtration system. The publication,
titled "Removal of COVID-19 spike protein, whole virus, exosomes
and exosomal microRNAs by the Hemopurifier® lectin-affinity
cartridge in critically Ill patients with COVID-19 infection," is
available here:
https://www.frontiersin.org/articles/10.3389/fmed.2021.744141/full
The publication documents two critically ill COVID-19 patients
receiving a combined total of nine, six-hour Hemopurifier®
treatment sessions. These two patient case studies are notable
because they are the first descriptions of the Hemopurifier®
successfully removing exosomes, exosomal microRNAs, and SARS-CoV-2
virus in patients with COVID-19. In the first patient, exosome and
exosomal microRNA removal was associated with improved
coagulopathy, oxygenation, and clinical recovery. In the second
patient, SARS-CoV-2 virus removal by the Hemopurifier® was
demonstrated, but the patient expired because the disease was
advanced and had triggered multiple organ system failures. The
patient had completed Hemopurifier® treatment and passed away while
receiving Continuous Renal Replacement Therapy (CRRT).
Hemopurifier® treatment sessions were well tolerated by both
patients without side effects.
"The emergence of COVID-19 variants has prompted an even greater
need for innovative COVID-19 treatments. These results demonstrate
that the Hemopurifier® can remove exosomes and viral particles
related to COVID-19 from the blood stream in humans," said
Charles J. Fisher, Jr., M.D., CEO of
Aethlon Medical and an author of the manuscript. "We remain
optimistic about our ongoing studies of the Hemopurifier® as a
treatment for critical COVID-19 patients."
The safety and feasibility of the Aethlon Hemopurifier® is being
evaluated in an active Early Feasibility Study, analogous to a
Phase 1 clinical trial for a drug or biologic, that is designed to
enroll up to 40 COVID-19 ICU patients [NCT04595903].
About Aethlon and the Hemopurifier®
Aethlon Medical is a medical technology company developing the
Hemopurifier®, a blood filtration system targeting life-threatening
viral diseases and cancer. The Hemopurifier® has demonstrated the
ability to remove exosomes and viral particles from the blood
stream in human studies. The Hemopurifier® has potential
applications in cancer and in severe viral diseases, where exosomes
may promote immune suppression and tumor metastasis in cancer, and
organ dysfunction in viral diseases. The Hemopurifier® holds two
U.S. Food and Drug Administration (FDA) Breakthrough Device
designations for the treatment of individuals with advanced or
metastatic cancer and also for the treatment of life-threatening
viral diseases that are not addressed with approved therapies.
The breakthrough device designation in cancer is 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. Under an
Investigational Device Exemption (IDE) application, the FDA
approved a single site, open-label Early Feasibility Study (EFS) to
evaluate the Hemopurifier® for reducing cancer-associated exosomes
prior to the administration of standard-of-care pembrolizumab
(KEYTRUDA®) in patients with recurrent and/or metastatic squamous
cell carcinoma of the head and neck. The EFS is being conducted at
the University of Pittsburgh Medical
Center Hillman Cancer Center.
The breakthrough device designation in viral disease is for an
open IDE application related to the treatment of life-threatening
viruses that are not addressed with approved therapies. The Company
is conducting a clinical trial approved by the FDA to treat up to
40 COVID-19 patients at up to 20 clinical sites in the U.S. In two
case studies of patients treated under Emergency Use Authorization
(EUA), the Hemopurifier® demonstrated binding of SARS-CoV-2 spike
protein and removal of SARS-CoV-2 virus and exosomal microRNAs
associated with organ disfunction from the circulation of human
patients.
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
enroll patients in and successfully complete trials in the Early
Feasibility Studies in COVID-19 patients, 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
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, 2021,
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 Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Media Contact:
Tony Russo, Ph.D.
Russo Partners, LLC
tony.russo@russopartnersllc.com
212-845-4251
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
212-966-3650
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SOURCE Aethlon Medical, Inc.