Breaking
Medical Technology News: Aethlon Medical (NASDAQ: $AEMD) Reaches Key Milestone with Enrollment
of the First Patient in (FPI) Its Hemopurifier® Cancer Trial in Australia
Patient
Enrolled at the Cancer Clinical Trial Unit, CALHN, Royal Adelaide Hospital
Aethlon’s Trial
is a Safety, Feasibility, and Dose Finding Study of the Hemopurifier® in
Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies
SAN DIEGO, CA - November 11, 2024
(Investorideas.com Newswire) Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused
on developing products to treat cancer and life-threatening infectious diseases,
today announced enrollment of the first patient in its Australian safety,
feasibility and dose-finding clinical trial of the Hemopurifier® in patients
with solid tumors who have stable or progressive disease during anti-PD-1
monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab)
(AEMD-2022-06 Hemopurifier Study). The patient was enrolled on October 29,
2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit,
CALHN, Royal Adelaide Hospital in Australia.
The first patient
completed screening activities confirming their eligibility on November 8, 2024,
and has now entered a two-month run-in period, receiving anti-PD-1 therapy.
During this time, concentrations of Extracellular vesicles (EVs)
and anti-tumor T
cell activity will be measured. If imaging after this two-month run-in period
reveals no improvement in the patient’s tumor, they will be treated with the
Hemopurifier, followed by monitoring to identify decreases in EV concentrations
and improvements in T cell anti-tumor activity.
Paid News Dissemination of behalf of
AEMD
Read this news, featuring AEMD in
full at https://www.investorideas.com/news/2024/11111AEMD-Hemopurifier-Cancer-Trial-Australia.asp
"Enrollment
of the first patient represents the achievement of a critical milestone for
Aethlon Medical in the clinical development of the Hemopurifier in Oncology,” stated
Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “We are thrilled
with the pre-screening activity being done to identify patients at Royal
Adelaide, as well as the second site, Pindara Private Hospital in the Gold
Coast. We are grateful to the patient for consenting to be part of this study. This
trial is our initial step in determining if the Hemopurifier treatment can
improve upon the 30-40% response rates to anti-PD-1 therapies such as Opdivo
and Keytruda.”
Currently, only
approximately 30% of patients who receive pembrolizumab or nivolumab will have
lasting clinical responses to these agents. EVs produced by tumors have been
implicated in the spread of cancers as well as the resistance to anti-PD-1
therapies. The Aethlon Hemopurifier has been designed to bind and remove these
EVs from the bloodstream, which may improve therapeutic response rates to
anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been
shown to reduce the number of exosomes from the plasma of cancer patient
samples.
The primary
endpoint of the approximately nine to 18-patient, safety, feasibility and
dose-finding trial is the incidence of adverse events and clinically
significant changes in safety lab tests of Hemopurifier treated patients with
solid tumors with stable or progressive disease at different treatment
intervals, after a two-month run in period of PD-1 antibody, Keytruda® or
Opdivo® monotherapy. Patients who do not respond to the therapy will be
eligible to enter the Hemopurifier period of the study where sequential cohorts
will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In
addition to monitoring safety, the study is designed to examine the number of
Hemopurifier treatments needed to decrease the concentration of EVs and if
these changes in EV concentrations improve the body’s own natural ability to
attack tumor cells. These exploratory central laboratory analyses are expected
to inform the design of a subsequent efficacy and safety, Premarket Approval
(PMA), study required by regulatory agencies.
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 exosomes from biological fluids, 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 raise additional capital on terms favorable to the Company, or at
all; the Company's
ability to successfully complete development of the Hemopurifier; the Company's
ability to successfully demonstrate the utility of the Hemopurifier in patients
with solid tumors in our oncology clinical trials; the Company’s ability to
achieve and realize the anticipated benefits from potential milestones; the
Company’s ability to obtain approval from the Ethics Committee of its third
location in Australia, including on the timeline expected by the Company; the
Company’s ability to enroll additional patients in its oncology clinical trials
in Australia and India, including on the timeline expected by the Company; whether
or not patients that are enrolled in the Company’s clinical trials will respond
to PD-1 antibody monotherapy; the number of patients that are enrolled in the
Company’s clinical trials that will ultimately be treated with the Company’s
Hemopurifier; the Company’s ability to manage and successfully complete its
clinical trials; the Company’s ability to successfully manufacture the
Hemopurifier in sufficient quantities for 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 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 Investorideas.com
More info on AEMD at
Investorideas.com Visit:
https://www.investorideas.com/CO/AEMD/
Get News Alerts on Aethlon Medical
Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced
news, articles and equity research as well as creates original content,
including video, interviews and articles. Original content created by
investorideas is protected by copyright laws other than syndication rights. Our
site does not make recommendations for purchases or sale of stocks, services or
products. Nothing on our sites should be construed as an offer or solicitation
to buy or sell products or securities. All investing involves risk and possible
losses. This site is currently compensated for news publication and
distribution, social media and marketing, content creation and more. Disclosure
is posted for each compensated news release, content published /created if
required but otherwise the news was not compensated for and was published for
the sole interest of our readers and followers. Contact management and IR of
each company directly regarding specific questions. Disclosure: Aethlon
Medical, Inc. (NASDAQ:AEMD) is a paid featured stock on Investorideas.com More
disclaimer info: https://www.investorideas.com/About/News/Clientspecifics.asp
https://www.investorideas.com/About/Disclaimer.asp
Learn more about
publishing your news release and our other news services on the
Investorideas.com newswire https://www.investorideas.com/News-Upload/ Global investors must adhere to regulations of
each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp
Biotech
Industry Stocks- investing ideas in biotechnology stocks, medical technology
and life sciences
Get more biotech and medical tech
news, articles,
podcasts and stock directories
