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Aethlon Medical Inc (AEMD) RSS Feed

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$AEMD Ther Apher Dial[Microbind® Affinity blood filter - approved for the treatment of COVID-19 patients]


. 2020 Jun 19;10.1111/1744-9987.13549. doi: 10.1111/1744-9987.13549. Online ahead of print.

https://pubmed.ncbi.nlm.nih.gov/32558210/

Clearance of chloroquine and hydroxychloroquine by the Seraph® 100 

Microbind® Affinity blood filter - approved for the treatment of COVID-19 patients

Malin-Theres Seffer 1 2, Jens Martens-Lobenhoffer 3, Julius J Schmidt 4, Gabriele Eden 1, Stefanie M Bode-Böger 3, Jan T Kielstein 1

Affiliations expand
PMID: 32558210 PMCID: PMC7323047 DOI: 10.1111/1744-9987.13549
Free PMC article

Abstract
On April 17th 2020 the US Food and Drug Administration granted Coronavirus Disease 2019 (COVID-19) emergency use authorizations 
for the Seraph® 100 Microbind® Affinity Blood Filter. 

The medical device is aimed to treat critically ill COVID-19 patients with confirmed or imminent respiratory failure. 

The aim of this life size in vitro pharmacokinetic study was to investigate the in-vitro adsorption of chloroquine and hydroxychloroquine from human plasma using equipment that is also used at the bedside. 

After start of the hemoperfusion Pre (Cpre ) Seraph® plasma levels were obtained at 5 (C5 ), 10 (C10 ), 15 (C15 ), 30 (C30 ), 60 (C60 ) and 120 (C120 ) minutes into the procedure. 

At two timepoints (5 min and 120 min) post (Cpost ) Seraph® plasma levels were determined that were used to calculate the plasma clearance. 

Both drugs were determined using a validated HPLC method Median [IQR] plasma clearance of the Seraph for chloroquine / hydroxychloroquine was 1.71 [0.51-4.38] ml/min / 1.79 [0.21-3.68] ml/min respectively. 

The lack of elimination was also confirmed by the fact that plasma levels did not change over the 120 min treatment. 

As neither chloroquine nor hydroxychloroquine were removed by the treatment with the Seraph dose adjustments in COVID-19 patients undergoing this treatment are not necessary. 

This article is protected by copyright. All rights reserved.

Keywords: COVID-19; blood purification; extracorporeal therapy.

This article is protected by copyright. All rights reserved.

Similar articles
In vitro elimination of anti-infective drugs by the Seraph® 100 Microbind® affinity blood filter.

Schmidt JJ, Eden G, Seffer MT, Winkler M, Kielstein JT.
Clin Kidney J. 2020 May 21;13(3):421-424. doi: 10.1093/ckj/sfaa063. eCollection 2020 Jun.

PMID: 32699622 Free PMC article.
Treatment for Severe Coronavirus Disease 2019 With the Seraph-100 Microbind Affinity Blood Filter.

Olson SW, Oliver JD, Collen J, Bunin J, Gleeson TD, Foster BE, Simmons MP, Chen HW, Ficke JB, Brown TE, Nau MT, Cebula BR, Kielstein J, Chung KK.
Crit Care Explor. 2020 Jul 30;2(8):e0180. doi: 10.1097/CCE.0000000000000180. eCollection 2020 Aug.
PMID: 32766569 Free PMC article.

Heparin 2.0: A New Approach to the Infection Crisis.
Seffer MT, Cottam D, Forni LG, Kielstein JT.
Blood Purif. 2020 Jul 2:1-7. doi: 10.1159/000508647. Online ahead of print.

PMID: 32615569 Review.
Efficacy of chloroquine and hydroxychloroquine in the treatment of COVID-19.

Meo SA, Klonoff DC, Akram J.
Eur Rev Med Pharmacol Sci. 2020 Apr;24(8):4539-4547. doi: 10.26355/eurrev_202004_21038.
PMID: 32373993 Review.

Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial.

Irvani SSN, Golmohammadi M, Pourhoseingholi MA, Shokouhi S, Darazam IA.
Trials. 2020 Jun 3;21(1):473. doi: 10.1186/s13063-020-04382-3.
PMID: 32493468 Free PMC article. Clinical Trial.





$AEMD 06-18-2020 Aethlon Announces FDA Approval of IDE Supplement for COVID-19 Patients
PR Newswire PR Newswire•June 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

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View original content:http://www.prnewswire.com/news-releases/aethlon-announces-fda-approval-of-ide-supplement--for-covid-19-patients-301079557.html

SOURCE Aethlon Medical, Inc.





$AEMD this should get ah few upticks !!!!!

ree;

Fourth Quarter & Fiscal Year End 2020 Investor Call
Jun 25, 2020 • 4:15pm EDT
Interested parties can register for the conference by navigating to http://dpregister.com/10145174. Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442
All callers should ask for the Aethlon Medical, Inc. conference call.
$AEMD FILINGS AND DISCLOSURE
OTC Disclosure & News
https://www.otcmarkets.com/stock/AEMD/disclosure
 
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PUBLISH DATE TITLE PERIOD END DATE STATUS
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Displaying 1 of 1 Disclosure & News
SEC Filings
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EFFECT 03/31/2020 PDFRTFHTML
replay of the call will be available approximately one hour after the end of the call through July 2, 2020. The replay can be accessed by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10145174.



AEMD, NO LONGER

SUSPENDED BY

THE SECURITIES AND

EXCHANGE COMMISSION 

03-25-2020, Aethlon Announces Issuance of European Patent for the Hemopurifier® in Cancer
March 25, 2020 Leave a comment 355 Views

https://www.exosome-rna.com/aethlon-announces-issuance-of-european-patent-for-the-hemopurifier-in-cancer/

Aethlon Announces Issuance of European Patent for the Hemopurifier® in Cancer
Posted by: Exosome RNA Administrator in Industry News, Patents, Press Releases March 25, 2020 0 356 Views

Aethlon Medical, Inc, a therapeutic medical device and technology company focused on unmet needs in global health, announced today

That it has received European Patent No. 1,993,600
(“the ‘600 Patent”) entitled “Extracorporeal Removal of Microvesicular Particles.”

The ‘600 patent embodies Aethlon’s Hemopurifier® technology designed
for the depletion of immune suppressive, and potentially cancer-promoting, exosomes from the circulatory system.






https://www.aethlonmedical.com/about



 SITE FOR HOW MANY INFECTED;
 https://www.worldometers.info/coronavirus/Coronavirus
  https://www.worldometers---POPULATION
  
https://www.worldometers.info/
 

 Combating Infectious Disease and Cancer with Immunotherapeutic Technologies

  At Aethlon Medical, we are a leading developer of immunotherapeutic technologies to combat infectious disease and cancer. To augment the body's natural immune defenses,
  the Aethlon Hemopurifier® eliminates life-threatening disease targets that are often shielded from the immune system and not well addressed by traditional drug therapies.

  The technology captures circulating viruses, bacterial toxins and cancer promoting exosomes through affinity attachment to a unique structure  cloaks these targets from immune detection.

  At present, the Hemopurifier® is being advanced under an FDA approved clinical study. Aethlon is also the majority owner of Exosome Sciences, Inc.,
  a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases.

  Diagnosing and Monitor Life-Threatening Diseases

   Exosome Sciences, Inc., in collaboration with majority shareholder Aethlon Medical,
   is focused on the discovery of exosomal biomarker candidates to diagnose and monitor life-threatening diseases.
   The proprietary Enzyme-Linked Lectin-Specific Assay (ELLSA™) serves as a platform to isolate exosomal biomarkers from a wide-range of bodily fluids.

   In preliminary studies, ELLSA™ demonstrated the ability to isolate exosomes from urine, which resulted in high-sensitivity detection of HIV-infection.
   Specific to neurological disorders, Exosome Sciences discovered TauSome™, an exosomal biomarker that may be the first non-invasive candidate to
   detect Chronic Traumatic Encephalopathy (CTE) in living individuals. In a study of former National Football League (NFL) players,
   TauSome levels were found to be significantly higher as compared to athlete control subjects who participated in non-contact sports.
   TauSome levels also correlated with cognitive decline based standardized tests of memory and psychomotor speed. Visit www.exosomesciences.com for additional details.
 

    May 18, 2017

   The Treatment of the Ebola Virus

    Time Magazine named the Hemopurifier® a "Top 25 Invention" and a "Remarkable Advance in Healthcare" based on its use in treating Ebola virus.
 

    We’re Developing Medical Countermeasures with Broad-Spectrum Capabilities

     Supporting an initiative set by the U.S. Department of Health and Human Services

      Emerging pathogens pose a significant threat to mankind. Of the hundreds of viral pathogens known to be infectious to man, only a few are addressed with
      proven antiviral drug or vaccine therapies. Beyond the looming threat of bioterrorism, a proliferation of international travel, urban crowding and global warming
      is expected to accelerate the emergence of future pandemics. In response, the U.S. Department of Health and Human Services (HHS) has established an initiative
      to support platform technology medical countermeasures with broad-spectrum capabilities. Based on preclinical studies and human treatment experiences, the Aethlon Hemopurifier® defines this initiative. 

     Administered to individuals infected with Ebola, Hepatitis C and HIV

      To date, Hemopurifier therapy has been administered to individuals infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV).
      In the case of Ebola, a remarkable response to a single administration of Hemopurifier therapy (comatose physician with multiple organ failure at the time), led to
      Time Magazine naming the Hemopurifier to be one of the "Top 25 Inventions" as well as one of the "Eleven Most Remarkable Advances in Healthcare."

     Status of clinical studies

      Beyond human treatment experiences, pre-clinical Hemopurifier studies have validated the broad-spectrum capture of numerous viral threats.
      These include: Chikungunya, Dengue and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection.

      Specific to pandemic influenza threats, Aethlon has validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus,
      which represents a model for the strain of influenza that killed an estimated 50 million victims in 1918 and 1919. In vitro studies of other viral threats are ongoing.
 
    https://coronavirus.jhu.edu/map.html
   
 

    

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