Breaking Medical Technology
News: Aethlon Medical (NASDAQ: $AEMD) Receives Ethics Committee Approval for
Hemopurifier® Cancer Trial
Aethlon Medical
Granted Full Ethics Approval From the Human Research Ethics Committee at
Central Adelaide Local Health Network for a Safety, Feasibility, and Dose
Finding Study of its Hemopurifier® in Cancer Patients with Solid Tumors Not
Responding to Anti-PD-1 Antibodies
SAN DIEGO,CA - June 18, 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 that, on June, 13, 2024,
the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health
Network (CALHN) granted full ethics approval for Aethlon's safety, feasibility
and dose-finding clinical trial of the Hemopurifier® in cancer 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 approval is valid for three years, until
June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff
at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in
Adelaide, Australia.
Currently,
only approximately 30% of patients who receive pembrolizumab or nivolumab will
have lasting clinical responses to these agents. Extracellular vesicles (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.
This news is paid advertisement/ news disseminated
on behalf of/issued on behalf of Aethlon Medical Inc.
Read this news,
featuring AEMD in full at https://www.investorideas.com/news/2024/06181AEMD-Ethics-Committee-Approval-for-Hemopurifier-Cancer-Trial.asp
"The approval from the Human Research Ethics Committee at
Central Adelaide Local Health Network marks a significant milestone for
Aethlon, as they deemed that our clinical study meets the requirements of the
Australia's National Statement on Ethical Conduct in Human Research,"
stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We
look forward to working closely with Prof. Brown and his staff, and with our
Contract Research Organizations, NAMSA and ReSQ Clinical Research. The next
steps include submission to the Therapeutic Goods Administration, the national
health regulatory agency of Australia, obtaining approval from the CALHN
Research Governance Committee, and conducting a site initiation visit to
facilitate patient enrollment. Following this Ethics Board approval, we plan to
submit to the Ethics Committees at two additional sites in Australia and one in
India."
The
primary endpoint of the approximate 18-patient, safety, feasibility and
dose-finding trial is safety. The trial will monitor any adverse events and
clinically significant changes in 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 successfully
complete development of the Hemopurifier and to successfully demonstrate the
utility of the Hemopurifier in patients with solid tumors in our planned
oncology clinical trials, the Company's ability work with the requisite
personnel and complete the next steps to facilitate patient enrollment, the
Company's ability to submit additional studies and obtain the approval by the
additional respective Ethics Boards of interested clinical trial sites in India
and in Australia, the Company's ability to recruit patients for and 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
Interim 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
917-513-5303
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
No comments:
Post a Comment