SAN DIEGO, Dec. 16, 2020
/PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a
therapeutic medical device and technology company focused on unmet
needs in viral diseases, oncology and inflammation, announced today
that the first patient has been treated in the Company's
first-in-human Early Feasibility Study (EFS) evaluating the
HEMOPURIFIER® in patients with recurrent and/or metastatic squamous
cell carcinoma of the head and neck. The study is enrolling
patients at UPMC Hillman Cancer Center in Pittsburgh, PA. (Hemopurifier Plus
Pembrolizumab in Head and Neck Cancer - Full Text View -
ClinicalTrials.gov).
The EFS, which is the device equivalent of a Phase 1 clinical
trial for a drug or biologic, is 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
primary endpoint for the study is safety of the HEMOPURIFIER® in a
clinical setting. Secondary endpoints include efficacy based
on response rates, progression-free and overall survival, and
changes in exosome concentration after HEMOPURIFIER® treatment.
In cancer, exosomes have been shown to participate in the
development and advancement of disease. Exosomes derived from
tumor cells may promote immune suppression and seed the spread of
metastasis. These tumor derived exosomes may also inhibit the
activity of immuno-oncology drugs such
as KEYTRUDA®. Tumor derived exosomes are not currently
addressed with any approved therapy.
Dan Zandberg, M.D., Medical
Oncologist and Hematologist at UPMC Hillman Cancer Center,
Associate Professor of Medicine at the University of Pittsburgh School of Medicine and
Principal Investigator of the study, stated, "We are excited to
have treated the first head and neck cancer patient with the
HEMOPURIFIER®. While KEYTRUDA® can markedly improve outcome
in some head and neck cancer patients, the majority of patients
still do not respond. If clearance of exosomes with the
HEMOPURIFIER® prior to treatment with KEYTRUDA® can increase the
number of patients who are able to respond to KEYTRUDA®, it could
represent an important advance in the treatment of this disease.
This trial represents the first step in this evaluation."
Charles J. Fisher, Jr., M.D.,
Chief Executive Officer of Aethlon, stated, "We are delighted to be
working with Dr. Zandberg and his colleagues at the University of Pittsburgh and UPMC Hillman to treat
the first head and neck cancer patient with the
HEMOPURIFIER®. By reducing the presence of immune suppressive
exosomes from the circulatory system of head and neck cancer
patients prior to treatment with KEYTRUDA®, we believe the
HEMOPURIFIER® could have the potential to improve patient outcomes
in this disease. The initiation of this first-in-human study
addressing cancer-associated exosomes is a significant step towards
evaluating the HEMOPURIFIER® for potentially improving the
efficacy of KEYTRUDA® in head and neck cancer."
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
cancer. The Hemopurifier also holds a Breakthrough Device
designation related to life-threatening viruses that are not
addressed with approved therapies. Under the Investigational
Device Exemption (IDE) application approved by FDA in October 2019 the FDA has also approved an
amendment to the Company's 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
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," "appear" 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. Factors that may contribute to
such differences include, without limitation, Aethlon Medical,
Inc.'s (the Company) ability to enroll additional patients in the
Early Feasibility Study, the Company's ability to successfully
complete the Early Feasibility Study and achieve the endpoints for
the study, or any future studies with its Hemopurifier or to
successfully develop and commercialize the Hemopurifier. 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. 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.