mick
10 months ago
NEUTRAL <> interesting yet ????? $AEMD 06-18-2020 Aethlon Announces FDA Approval of IDE Supplement for COVID-19 Patients
PR Newswire PR NewswireโขJune 18, 2020
Allows for enrollment of up to 40 subjects in up to 20 centers
https://finance.yahoo.com/news/aethlon-announces-fda-approval-ide-131900535.html
SAN DIEGO, June 18, 2020 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the U.S. Food and Drug Administration (FDA) has approved a
supplement to the Company's existing Investigational Device Exemption (IDE) for the Company's Hemopurifier® in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19 in a new feasibility study.
The feasibility study, which is the device equivalent of a phase 1 trial, will enroll up to 40 subjects at up to 20 centers in the U.S. Subjects will have established laboratory diagnosis of COVID-19,
be admitted to an intensive care unit (ICU) and will have acute lung injury and/or severe or life threatening disease among other criteria.
The Hemopurifier has previously been tested in patients with hepatitis
C virus (HCV) infection and in one patient with Ebola virus infection.
A laboratory version of the Hemopurifier has also been shown to clear multiple other viruses in vitro including a model version of the
Middle Eastern Respiratory Syndrome (MERS) virus which is a
coronavirus from the same family as the SARS-CoV-2 virus that causes COVID-19.
Timothy C. Rodell, M.D., Chief Executive Officer of Aethlon, stated,
"We believe that the Hemopurifier may have the potential to help severely affected patients with COVID-19.
We believe that clearing circulating virus in these patients, in combination with other supportive measures, could improve outcomes in this deadly disease."
The Hemopurifier is an FDA designated "Breakthrough Device" for the treatment of life-threatening viruses that are not addressed with approved therapies.
The Hemopurifier also holds a Breakthrough Device designation 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.
About Aethlon Medical, Inc.
Aethlon Medical, Inc. is focused on addressing unmet needs in global health.
The Aethlon Hemopurifier is a clinical-stage device designed to combat cancer and life-threatening viral infections.
Aethlon also owns 80% of Exosome Sciences, Inc., which is focused on
the discovery of exosomal biomarkers to diagnose and monitor cancer
and neurological disease progression. Additional information can be found online at
http://www.AethlonMedical.com and http://www.ExosomeSciences.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," "appear" 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. Factors that may contribute to such differences include, without limitation, Aethlon Medical, Inc.'s (the Company) ability to enroll patients and to successfully complete the Early Feasibility Studies in viral diseases and cancer and achieve the endpoints for the study or any future studies with its Hemopurifier or to successfully develop and commercialize the Hemopurifier. 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, 2019, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. 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.
Continue reading
http://ih.advfn.com/stock-market/NASDAQ/aethlon-medical-AEMD/stock-news/82687431/aethlon-announces-fda-approval-of-ide-supplement
Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 x3300
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
Cision
Cision
More
View original content:http://www.prnewswire.com/news-releases/aethlon-announces-fda-approval-of-ide-supplement--for-covid-19-patients-301079557.html
mick
10 months ago
NEUTRAL <> interesting yet ????? $AEMD 06-18-2020 Aethlon Announces FDA Approval of IDE Supplement for COVID-19 Patients
PR Newswire PR NewswireโขJune 18, 2020
Allows for enrollment of up to 40 subjects in up to 20 centers
https://finance.yahoo.com/news/aethlon-announces-fda-approval-ide-131900535.html
SAN DIEGO, June 18, 2020 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the U.S. Food and Drug Administration (FDA) has approved a
supplement to the Company's existing Investigational Device Exemption (IDE) for the Company's Hemopurifier® in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19 in a new feasibility study.
The feasibility study, which is the device equivalent of a phase 1 trial, will enroll up to 40 subjects at up to 20 centers in the U.S. Subjects will have established laboratory diagnosis of COVID-19,
be admitted to an intensive care unit (ICU) and will have acute lung injury and/or severe or life threatening disease among other criteria.
The Hemopurifier has previously been tested in patients with hepatitis
C virus (HCV) infection and in one patient with Ebola virus infection.
A laboratory version of the Hemopurifier has also been shown to clear multiple other viruses in vitro including a model version of the
Middle Eastern Respiratory Syndrome (MERS) virus which is a
coronavirus from the same family as the SARS-CoV-2 virus that causes COVID-19.
Timothy C. Rodell, M.D., Chief Executive Officer of Aethlon, stated,
"We believe that the Hemopurifier may have the potential to help severely affected patients with COVID-19.
We believe that clearing circulating virus in these patients, in combination with other supportive measures, could improve outcomes in this deadly disease."
The Hemopurifier is an FDA designated "Breakthrough Device" for the treatment of life-threatening viruses that are not addressed with approved therapies.
The Hemopurifier also holds a Breakthrough Device designation 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.
About Aethlon Medical, Inc.
Aethlon Medical, Inc. is focused on addressing unmet needs in global health.
The Aethlon Hemopurifier is a clinical-stage device designed to combat cancer and life-threatening viral infections.
Aethlon also owns 80% of Exosome Sciences, Inc., which is focused on
the discovery of exosomal biomarkers to diagnose and monitor cancer
and neurological disease progression. Additional information can be found online at
http://www.AethlonMedical.com and http://www.ExosomeSciences.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," "appear" 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. Factors that may contribute to such differences include, without limitation, Aethlon Medical, Inc.'s (the Company) ability to enroll patients and to successfully complete the Early Feasibility Studies in viral diseases and cancer and achieve the endpoints for the study or any future studies with its Hemopurifier or to successfully develop and commercialize the Hemopurifier. 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, 2019, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. 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.
Continue reading
http://ih.advfn.com/stock-market/NASDAQ/aethlon-medical-AEMD/stock-news/82687431/aethlon-announces-fda-approval-of-ide-supplement
Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 x3300
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
Cision
Cision
More
View original content:http://www.prnewswire.com/news-releases/aethlon-announces-fda-approval-of-ide-supplement--for-covid-19-patients-301079557.html
Monroe1
1 year ago
The Company recently contracted with NAMSA, LLC 2023 (NAMSA), www.namsa.com, a world-leading MedTech CRO offering global end-to-end development services, to direct our planned oncology study in Australia and the United States. This new clinical trial in oncology is planned to be a safety, feasibility and dose finding trial in solid tumors failing anti-PD-1 antibodies. We believe that this trial will help inform the design of future efficacy trials of our Hemopurifier in oncology. The Company plans to initiate this trial first in Australia and then in the United States. {very smart move to hire Dr. Arnold and commence trials in Australia first. The US fda is a toxic organization and everyone who knows anything about pharmaceuticals knows this but may not admit it in public}
We recently hired Lee Arnold, PhD, as our new Chief Scientific Officer. Dr. Arnold is a creative scientific leader with 36 years of accomplishments in molecularly-targeted drug discovery. After an initial eight publications in biophysics and biochemistry as an undergraduate at University of Waterloo, he earned a PhD in Organic Chemistry from University of Alberta. Dr. Arnold began his career in pharma research at Syntex, Inc. (Canada), and then joined Pfizer Inc., where he was the inventor of Tarceva® (erlotinib) for non-small cell lung cancer, or NSCLC. During his tenure at BASF/Abbott Bioresearch Center, he established medicinal & combinatorial chemistry operations, and initiated and led two multinational multidisciplinary projects in angiogenesis, ultimately leading to linifanib (ABT-869). As Vice President of Research at OSI Pharmaceuticals, Dr. Arnold and his teams discovered four oncology development candidates, including the โfirst-in-classโ agents linsitinib (IGF-1R), and ASP7486 (TORC1/2).
Dr. Arnold also has served as Chief Scientific Officer (CSO) in a number of innovative start-up biotechnology companies. Just prior to joining Aethlon Medical, Dr. Arnold was the CSO and cofounder of Pardes Biosciences, Inc., which was established at the start of the COVID pandemic as a virtual company that discovered and advanced the oral protease inhibitor, pomotrelvir, into clinical trials for SARS-CoV2 in only 17 months. Dr. Arnoldโs inventive and leadership contributions in drug discovery and development to date have resulted in an approved drug, and 16 additional development candidates, currently fueling eight clinical trials in oncology, immunology and virology. These achievements are documented in over 94 published patents and applications, and more than 39 peer-reviewed publications.