SAN
DIEGO, Oct. 10, 2023 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused
on developing products to treat cancer and life threatening viral
infections and for use in organ transplantation, today announced
that it has received clearance from the Drug Controller General of
India (DCGI), the central drug
authority in India, to conduct a
phase 1 safety, feasibility and dose-finding trial of the company's
Hemopurifier® in patients with solid tumors who have
stable or progressive disease during anti-PD-1 monotherapy
treatment, such as Keytruda® or Opdivo®. The
trial is expected to begin following completion of an internal in
vitro binding study of relevant targets, and subsequent approval by
the respective Ethics Boards of interested sites in India.
"Receipt of clearance from the DCGI to conduct this early
feasibility study is another important step in the progression of
our plan to evaluate use of our Hemopurifier as a treatment option
in multiple tumor types, where cancer associated extracellular
vesicles may promote immune suppression and resistance to anti-PD-1
antibodies," stated Charles J. Fisher,
Jr., M.D., Chief Executive Officer of Aethlon Medical. "We
expect to begin patient recruitment once we have completed an
internal in vitro binding study to confirm that relevant targets
are bound by the Hemopurifier, and after we receive subsequent
approval by the Ethics Boards of the interested sites for the trial
in India. The planned oncology
trial in India is designed to be a
safety study in nine to 18 patients to examine three cohorts of
Hemopurifier treatments in patients receiving pembrolizumab
(Keytruda) or nivolumab (Opdivo) therapy as standard of care for
their malignancy. The trial is designed to include multiple tumor
types, as well as Hemopurifier dosing intervals, to help direct
further development of the Hemopurifier for use in
oncology.
The trial's primary endpoint will be to assess the safety and
feasibility of the Hemopurifier-treated patients at different
treatment intervals in patients with solid tumors with stable or
progressive disease after 60 days of pembrolizumab or nivolumab
monotherapy. Additionally, the effects of Hemopurifier treatment on
the immune response to cancer will be assessed.
"Additionally, we continue to work with our contract research
organization, North American Science Associates, LLC (NAMSA), to
initiate a similar oncology clinical trial in Australia; specifically, a safety, feasibility
and dose finding trial in solid tumors in patients failing
treatment with anti-PD-1 antibodies. We believe these planned
trials will help inform future oncology efficacy trials with our
Hemopurifier," concluded Dr. Fisher.
About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic company focused on
developing the Hemopurifier, a clinical stage immunotherapeutic
device which is designed to combat cancer and life-threatening
viral infections. In human studies, the Hemopurifier has
demonstrated the removal of life-threatening viruses and harmful
exosomes from blood utilizing its proprietary lectin-based
technology. This action has potential 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. The Hemopurifier also holds an FDA Breakthrough Device
designation and an open Investigational Device Exemption (IDE)
application related to the treatment of life-threatening viruses
that are not addressed with approved therapies.
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
successfully complete development of the Hemopurifier and to
successfully demonstrate the utility of the Hemopurifier in cancer
and infectious diseases, the Company's ability to complete
the internal binding study of relevant extracellular vesicles, the
Company's ability to obtain the approval by the respective Ethics
Boards of interested clinical trial sites in India and in Australia; the Company's ability to
manage its clinical trials, 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, 2023, 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
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
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content:https://www.prnewswire.com/news-releases/aethlon-receives-clearance-from-drug-controller-general-of-india-for-potential-phase-1-trial-of-its-hemopurifier-in-oncology-301951765.html
SOURCE Aethlon Medical, Inc.