SAN DIEGO, Sept. 30, 2021 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a company developing medical
technology to treat cancer and life-threatening infectious disease,
today announced that it has entered into an agreement with PPD,
Inc. (Nasdaq: PPD), a leading global contract research organization
(CRO), for PPD to oversee the company's clinical studies
investigating the Hemopurifier, Aethlon's therapeutic blood
filtration system, for infectious disease indications.
Pursuant to the agreement, PPD will manage Aethlon's ongoing
study of the Hemopurifier for patients who are critically ill with
COVID-19 (NCT04595903). PPD and Aethlon also can agree to include
additional studies under their agreement.
"Aethlon is committed to progressing the clinical development of
the Hemopurifier," said Charles J.
Fisher, M.D., Chief Executive Officer of Aethlon Medical.
"PPD is a world class organization with significant experience
operating clinical studies. Aethlon plans to move quickly to
leverage this experience to advance our studies of the Hemopurifier
in COVID-19 patients."
About Aethlon and the Hemopurifier®
Aethlon Medical is a biotechnology company developing the
Hemopurifier, a therapeutic blood filtration system indicated for
infectious diseases and cancer, as its lead technology. In human
studies, the Hemopurifier has demonstrated the removal of
life-threatening viruses and harmful exosomes from blood utilizing
a proprietary lectin-based technology. This action has
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. 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 Hemopurifier also holds an FDA Breakthrough Device
designation and an open IDE application related to the treatment of
life-threatening viruses that are not addressed with approved
therapies. A recent amendment to the IDE enabled Aethlon to
implement a new EFS protocol 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 (EU), the Hemopurifier demonstrated
binding of SARS-CoV-2 spike protein and removal of SARS-CoV-2 virus
from the circulation of a human patient.
Additional information can be found at
www.AethlonMedical.com.
About PPD
PPD is a leading global contract research organization providing
comprehensive, integrated drug development, laboratory and
lifecycle management services. Our customers and partners include
pharmaceutical, biotechnology, medical device, academic and
government organizations. With more than 30,000 professionals
worldwide, PPD has conducted clinical trials in more than 100
countries to help customers deliver life-changing therapies to
improve health. We apply innovative technologies, therapeutic
expertise and a firm commitment to quality to bend the cost and
time curve of drug development and optimize value. For more
information, visit www.ppd.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 dependence
upon PPD to manage its clinical trials under the Master Services
Agreement between the parties, the Company's ability to enroll
patients in and successfully its complete trials in COVID-19
patients and in its head and neck cancer trials, the Company's
ability to successfully treat patients under any Emergency Use
pathway, the Company's ability to successfully complete development
of its Hemopurifier, 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.