SAN DIEGO, June 3, 2021 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical device technology company
focused on unmet needs in global health, today announced the
publication of a pre-print manuscript highlighting two case studies
of critically ill COVID-19 patients treated with the Aethlon
Hemopurifier®. Both patients were given access to Hemopurifier®
treatment through Emergency Use. The manuscript is 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" and was published
in Research Square.
The Hemopurifier® is a cartridge that is designed to filter
viruses and exosomes from the blood. The manuscript describes the
use of the Hemopurifier® for a total of nine sessions in two
critically ill COVID-19 patients. Each of these two case studies is
notable for unique reasons. The first is notable for the
improvement in COVID-19 associated coagulopathy (CAC), lung injury,
inflammation, and tissue injury despite the absence of demonstrable
COVID-19 viremia (having demonstrated strong viremia earlier in the
patient's disease cycle), indicating that the removal of exosomes
contributed to the patient's recovery. This patient received eight
Hemopurifier treatments without complications and eventually was
weaned from a ventilator and was discharged from the hospital.
The second patient is notable for the first-ever demonstration
of in vivo removal of SARS-CoV-2 virus from the blood stream
of an infected patient. The patient completed a six hour
Hemopurifier® treatment without complications and subsequently was
placed on Continuous Renal Replacement Therapy (CRRT). The patient
ultimately expired three hours after being placed on CRRT because
of the advanced stage of the disease.
"The COVID-19 pandemic has affected the world over, prompting
the need for innovative treatment approaches. We believe that the
Hemopurifier® is such an innovation, as it is the only known device
that can filter out exosomes, which are thought to play a role in
the severity of infectious diseases like COVID-19," said
Charles J. Fisher, Jr., CEO of
Aethlon Medical and an author of the manuscript. "Given the success
of the Hemopurifier® as a treatment for Ebola patients, we remain
optimistic about our ongoing work in the treatment of COVID-19
patients. These two case studies indicate that the Hemopurifier®
was successfully able to clear SARS-CoV-2 virus and associated
exosomes from the blood stream, resulting in a potential benefit
for one of the critical COVID-19 patients that were treated."
In addition to the two case studies, 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 will enroll up to 40 COVID-19 ICU patients
[NCT04595903]. The pre-print manuscript is being submitted to peer
reviewed journals, and Aethlon expects it to be published in the
near future.
About Aethlon and the Hemopurifier®
Aethlon is focused on addressing unmet needs in global health.
The Aethlon Hemopurifier is a clinical-stage immunotherapeutic
device designed to combat cancer and life-threatening viral
infections. In cancer, the Hemopurifier is designed to deplete the
presence of circulating tumor-derived exosomes that promote immune
suppression.
The Hemopurifier® is an FDA designated "Breakthrough Device"
related to 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, in
October 2019, the FDA approved an
Early Feasibility Study (EFS), which is the device equivalent of a
Phase 1 clinical trial for a drug or biologic, in a single center,
open label trial in 10 to 12 subjects. The study is evaluating the
HEMOPURIFIER® for reducing cancer-associated exosomes prior to the
administration of standard-of-care pembrolizumab (KEYTRUDA®), which
is a first-line therapy for 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 Hemopurifier also holds a Breakthrough Device designation
related to life-threatening viruses that are not addressed with
approved therapies. In June 2020, the
FDA approved an amendment to the Company's existing open IDE for
the Hemopurifier in life threatening viral infections, to allow for
the treatment of patients with SARS-CoV-2/COVID-19 infection. This
will allow for up to 40 of these patients to be treated under a new
Early Feasibility Study protocol at up to 20 clinical sites in the
U.S.
Aethlon also owns 80% of Exosome Sciences, Inc., which is
focused on the discovery of exosomal biomarkers to diagnose and
monitor cancer and neurological disease progression. Additional
information can be found online at www.AethlonMedical.com and
www.ExosomeSciences.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 the COVID-19 trial,
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, 2020, 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.