SAN DIEGO, Aug. 6, 2020 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and
technology company focused on unmet needs in oncology and viral
diseases announced today that the National Institute for Dental and
Craniofacial Research (NIDCR), a unit of the National Institutes
for Health (NIH), has awarded a grant for studies in head and neck
cancer that will be a collaborative project between Aethlon and the
UPMC Hillman Cancer Center at the University
of Pittsburgh.
The grant, entitled "Depleting exosomes to improve
responses to immune therapy in head and neck squamous cell
carcinoma" will profile the biomarkers of exosomes in
patients with recurrent and metastatic head and neck cancer and
will explore the impact of clinical depletion of exosomes using
Aethlon's proprietary Hemopurifier device. Exosomes are nanosized
particles that are released in large quantities from cancer cells
and carry the complement of a tumor's genetic and protein cargo,
which endows them with the capacity to fuel cancer growth and
immune suppression. The Hemopurifier is being advanced as a
potential therapeutic device for oncology by virtue of its capacity
to capture and remove exosomes from plasma.
The total value of the award is $3.5
million over five years for multi-institution studies that
will be led by Drs. Theresa
Whiteside at UPMC and Annette
Marleau at Aethlon as Principal Investigators. The funds
will be primarily allocated to UPMC and two other participating
academic institutions that will apply their expertise in
immuno-oncology to programs that could accelerate the clinical
advancement of the Hemopurifier.
"We are delighted to have the opportunity to work with Dr.
Whiteside, a leading researcher in the area of tumor-derived
exosomes, and the multidisciplinary team that has been assembled to
evaluate the effects of exosomes in head and neck cancer," stated
Timothy C. Rodell, M.D., CEO of
Aethlon Medical. "Head and neck cancer continues to have a poor
prognosis due to disease recurrence and the development of
metastatic disease. We believe that the real value of this
grant for Aethlon is that this work will provide insights into the
potential clinical benefits of depleting circulating exosomes using
the Hemopurifier for improving the responses of patients to the
standard immunotherapy treatments."
"We are appreciative of the funding from NIDCR for this
investigation of the roles of exosomes in head and neck cancer,"
stated Theresa Whiteside, Ph.D.,
Principal Investigator and Professor of Pathology, Immunology and
Otolaryngology at UPMC. "Exosomes have emerged as major
contributors to tumor-associated
immune suppression and as significant barriers to cancer
therapies. The overarching objective of this work will be to
advance therapeutic capabilities and novel exosome-based predictive
tools for head and neck cancer."
About Aethlon Medical, Inc. and the Hemopurifier®
Aethlon Medical, Inc. is focused on addressing unmet needs in
global health. The Aethlon Hemopurifier is a clinical-stage device
designed to combat cancer and life-threatening viral
infections.
In preclinical studies in cancer, the Hemopurifier depletes the
presence of circulating tumor-derived exosomes that are believed to
promote immune suppression. These tumor derived exosomes also
appear to seed the spread of metastases and therefore may inhibit
the benefit of leading cancer therapies. 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 FDA
has approved an Investigational Device Exemption (IDE) application
to initiate an Early Feasibility Study (EFS) of the
Hemopurifier® in patients with head and neck cancer in
combination with standard of care pembrolizumab (Keytruda).
The Hemopurifier also is an FDA designated "Breakthrough
Device" related to life-threatening viruses that are not addressed
with approved therapies. The FDA also has approved a supplement to
the Company's existing IDE to allow for the testing of the
Hemopurifier® in patients with SARS-CoV-2/COVID-19 in a
new feasibility study.
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 successfully
complete the grant for studies in head and neck cancer with the
UPMC Hillman Cancer Center at the University
of Pittsburgh, or to successfully complete the Early
Feasibility Studies in head and neck cancer or in COVID-19,
Aethlon's ability to demonstrate that the removal of exosomes with
the Hemopurifier will result in better outcomes for the treatment
of cancer, and Aethlon's ability to successfully develop and
commercialize the Hemopurifier, its ability to raise additional
funds and other 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, 2019,
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.
858-459-7800 x3300
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.