(Investorideas.com
Newswire) a leading investment platform for retail investors reports
breaking Medical Tech Stock news for
Aethlon Medical, Inc.
(Nasdaq: AEMD), a medical therapeutic company focused on developing products to
treat cancer and life-threatening infectious diseases.
Aethlon Medical, Inc.
(Nasdaq: AEMD), a clinical-stage biotechnology company
developing the investigational Aethlon Hemopurifier®, an
extracorporeal device for oncology and other indications, today
announced that the independent Data Safety Monitoring Board (DSMB)
overseeing its ongoing clinical trial AEMD-2022-06 has completed its
scheduled safety review of the second cohort participant data and
recommended advancing to the third and final cohort. They also
stated that “no safety concerns were noted with Hemopurifier
device/procedure”.
The trial, titled “Safety, Feasibility, and Dose-Finding Study
of Aethlon Hemopurifier in Patients with Solid Tumors Who Have
Stable or Progressive Disease While on a Treatment That Includes
Pembrolizumab or Nivolumab,” is being conducted to assess the
Hemopurifier’s safety, feasibility, and optimal dosing.
The DSMB—comprised of independent medical experts in
nephrology and oncology—reviewed data from participants
enrolled in the second cohort, in which patients received two
Hemopurifier treatments over a one-week period. Based on their
evaluation, the DSMB found no safety concerns and confirmed that the
Hemopurifier continues to demonstrate a favorable safety and
tolerability profile. To date, no serious adverse events (SAEs) or
Dose-Limiting Toxicities (DLTs) related to the Hemopurifier device
or treatment have been reported.
“The DSMB’s continued positive recommendation supports the safety
profile observed to date and allows us to advance into the third
and final cohort of this study,” said Steven LaRosa, M.D,
Chief Medical Officer of Aethlon Medical. “We are encouraged by
the gathering momentum of the trial and having a final data set
and clinical study report to share with potential investors,
partners and regulatory agencies”.
Enrollment for Cohort 3 is now open. In this final cohort,
participants will receive three Hemopurifier treatments over a
one-week period, further evaluating safety, feasibility, and dosing
parameters at the study’s three active clinical sites in
Australia. This trial is designed to enroll approximately 9 to 18
patients with solid tumors who have stable or progressive disease
while receiving treatment that includes Pembrolizumab
(Keytruda®) or Nivolumab (Opdivo®).
The primary endpoint of this trial is the incidence of adverse
events and clinically significant changes in safety laboratory tests
of Hemopurifier-treated patients. In addition to safety monitoring,
the study is designed to examine the number of Hemopurifier
treatments needed to decrease the concentration of extracellular
vesicles (EVs) and if these changes in EV concentrations improve the
body’s own natural ability to attack tumor cells. These
findings are expected to inform the design of a future efficacy and
safety Premarket Approval (PMA) study required by regulatory
authorities.
Aethlon Medical, Inc. remains committed to advancing the
Hemopurifier for use in oncology and will continue to provide
updates as the clinical trial progresses.
About Aethlon Medical, Inc.
Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinical-stage medical
device company headquartered in San Diego, California. Aethlon is
advancing the Hemopurifier, to address unmet needs in oncology and
infectious disease, using a novel platform designed to selectively
remove circulation pathogenic targets from biologic fluids.
For more information, visit
www.AethlonMedical.com
and follow the Company on LinkedIn.
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 and
for use in organ transplantation. In human studies, the Hemopurifier
has demonstrated the removal of life-threatening viruses and in
pre-clinical studies, the Hemopurifier has demonstrated the removal of
harmful EVs from biological fluids, utilizing its proprietary
lectin-based technology. This action has potential applications in
cancer, where EVs 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 EVs 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. Risks and uncertainties include, but
are not limited to, clinical trial outcomes, regulatory approvals,
the ability to obtain additional financing, and market acceptance of
the Company’s products, as more fully described in the Company’s
filings with the Securities and Exchange Commission. These
forward-looking statements are based upon Aethlon’s current
expectations and involve assumptions that may never materialize or
may prove to be incorrect. 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 Executive
Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan
Communications, LLC
susan@sanoonan.com
Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on
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a paid featured medical tech stock on
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