geht hier was

 

Wie siehst du das denn mit dem Antikörper Medikament von "Trump"???
Soll ja jetzt in Serie gehen.  
 

Hallo

Vielen Dank erstmal aber ist die skurrile Zulassung aktuell oder schon älter.

Viele Grüße  

das ist so ziemlich die erste Zulassung aber was deine erste Frage betrifft
was sehr Interessantes !!

Eins der Medikamente, das für das Aufrechterhalten der Lungenfunktion erprobt wird, enthält den Wirkstoff Aviptadil, eine synthetische Version des natürlich im Menschen vorkommenden Moleküls VIP. Das Schweizer Unternehmen Relief Therapeutics hat dafür in der EU eine Zulassung zur Behandlung von akutem Atemnotsyndrom (ARDS) und Sarkoidose, brachte es aber in Deutschland bislang noch nicht auf dem Markt. Der Wirkstoff wirkt u. a. antientzündlich und schützt bestimmte Lungenzellen (Alveolar Typ-2-Zellen) vor Virenbefall. Sie sind ein bevorzugtes Ziel von SARS-CoV-2 und für das Aufrechterhalten der Lungenfunktion besonders wichtig. Das Unternehmen NeuroRx führte nach positiven Labordaten mit Unterstützung von Relief Therapeutics in den USA eine Phase II/III-Studie mit schwer erkrankten Covid-19-Patienten (Symptome schweren Lungenversagens; beatmet) durch. Unter der intravenös verabreichten Therapie erholten sich die Patienten schneller von den Atemwegssymptomen. NeuRx hat daraufhin eine Emergency Use Authorization bei der FDA beantragt. Relief Therapeutics hat zudem zusammen mit dem Unternehmen AdVita Lifescience in Gundelfingen eine Phase II-Studie in mit mit einer inhalierbaren Formulierung des Wirkstoffs begonnen. Ziel ist auch hier, bei Covid-19-Patienten das akute Atemnot-Syndrom zu vermeiden.  

This is very interesting and i hope they bring it with Advita to Germany !! :-)The Swiss company Relief Therapeutics has approval for it in the EU for the treatment of acute respiratory distress syndrome (ARDS) and sarcoidosis, but has not yet brought it to market in Germany.The goal here is also to prevent acute respiratory distress syndrome in Covid-19 patients.!!!!!!!!!!! 🙂  

und ein Stern mehr für Toni1111 . Ich fass es nicht :-( .  

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3830051
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228  

was hast du denn plötzlich für ein problem? toni hat diesen thread eröffnet, da war an relief noch nicht im traum zu denken. eigentlich hätte es spätestens nach der umfirmierung in relief einen neuen thread geben müssen, zumal ja toni auch schon seit langem nicht mehr in diesem forum federführend ist...

aufgrund deiner zahlreichen beiträge, wärst du eigentlich prädestiniert, dies zu tun...  

ich habe doch kein Problem , nur gedacht mal ein wenig mehr Öffentlichkeit
täte der Sache ganz gut und da kam mir die Idee wenn unser Thread Toni1111
unter den Topforen gelistet würde , mehr Interessenten mal vorbei schauen .
Aber so wird das nix :-) . Einen neuen Thread anfangen ist auch nicht so gut
da hier die geballte Ladung an Infos, Meinungen und Analysen zum Nachschlagen
vorliegen . In diesem Sinne euch allen noch einen schönen Abend und eine gute Nacht !! :-)

2 neue Klinikstandorte hizugekommen :-)

https://clinicaltrials.gov/ct2/history/...0&C=merged#StudyPageTop  

FDA APPROVAL WITH LESS THAN 50% EFFICACY???

https://www.forbes.com/sites/roberthart/2021/07/...tudy-suggests/amp/

CAN WE HELP THE AFFLICTED???
Some of these people who are now injured after taking a COVID shot used to attack and criticize those who don’t trust the shots, and when encountering information that goes against the corporate media narrative, they used to believe these were all “conspiracy theories.”

But they don’t believe that anymore, now that their lives are ruined.

These are the voices of those who regret their decisions, and their voices are being heavily censored. The “health authorities” don’t want you to listen to them.

So ask yourself, if these shots are so beneficial, why do they need to attack and censor dissenting opinions?

When they claim that all these people who regret taking the shots and are now warning you about them, are “actors” who are lying, what benefit would they receive for faking their injuries? Who would pay them to say these things??

https://medicalkidnap.com/2021/08/18/...hot-and-their-message-to-you/

Vascular dysregulation of the vasa nervorum of the facial nerve is believed to be a central factor in the pathogenesis of Bell's palsy…. Our findings suggest that there must be a vascular regulation in the facial nerve which is controlled by various neuropeptides.

https://pubmed.ncbi.nlm.nih.gov/7684228/

The neuropeptides substance P, calcitonin gene-related peptide (CGRP) and vasoactive intestinal polypeptide (VIP) have been considered as important mediators in migraine and other primary headaches.

https://pubmed.ncbi.nlm.nih.gov/21979827/

Vasoactive intestinal peptide (VIP) is a neuropeptide that exerts various vascular and cardioprotective functions and regulates immune function and inflammatory response at multiple levels. However, its role in inflammatory cardiovascular disorders is largely unknown. Myocarditis and atherosclerosis are two inflammatory and autoimmune cardiovascular diseases that cause important adverse circulatory events…. Systemic VIP treatment reduced the number and size of atherosclerotic plaques in carotid, aorta, and sinus in hypercholesterolemic mice. VIP reduced Th1-driven inflammatory responses and increased regulatory T cells in atherosclerotic arteries and their draining lymph nodes. VIP also regulated cholesterol efflux in macrophages and reduced the formation of foam cells and their presence in atherosclerotic plaques…. These findings encourage further studies aimed to assess whether VIP can be used as a pharmaceutical agent to treat heart inflammation and atherosclerosis.

https://pubmed.ncbi.nlm.nih.gov/29669783/

Note: Zyesami (TM) lacks toxicity and does far more good than a vaccine, does it not? ———

Zyesami (Aviptadil) COVID-19 Therapeutic Description ———

Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which the late Dr. Sami first discovered Said in 1970, for whom ZYESAMI™ is named. Because of its lack of toxicity and low cost of manufacture compared to proprietary biologics, VIP may be uniquely attractive to those focused on global countermeasures against COVID-19, says the company. ———

VIP is known to target the VPAC1 receptor of the alveolar type II cell (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.

https://www.precisionvaccinations.com/vaccines/...ovid-19-therapeutic

Definitions: ————

Apoptosis: the death of cells which occurs as a normal and controlled part of an organism's growth or development. ———

Cytokine: any of a number of substances, such as interferon, interleukin, and growth factors, which are secreted by certain cells of the immune system and have an effect on other cells. ———

TNF: If you have an immune system disease like rheumatoid arthritis (RA), you may have heard your doctor use the term TNF. It's shorthand for tumor necrosis factor, a protein in your body that causes inflammation and helps coordinate the process. ———

CD4/CD8 ratio: A normal CD4/CD8 ratio is greater than 1.0, with CD4 lymphocytes ranging from 500 to 1200/mm 3 and CD8 lymphocytes ranging from 150 to 1000/mm 3. If your ratio is higher than 1, it means your immune system is strong and you may not have HIV. If your ratio is less than 1, you may have: HIV. ———

Macrophages exposed to VIP or PACAP before HIV-1 infection showed resistance to viral replication, comparable to that observed when the cells were treated after infection. Also, multiple treatments with a suboptimal dose of VIP or PACAP after macrophage infection resulted in a decline of virus production similar to the inhibition promoted by a single exposure to the optimal inhibitory concentration. Cellular signaling pathways involving cAMP production and activation of protein kinases A and C were critical components of the VIP and PACAP anti-HIV-1 effects.

https://www.frontiersin.org/articles/10.3389/fimmu.2018.01336/full
 

https://ir.nrxpharma.com/news-events/...ith-cardinal-health-to-ensure

Denke wir sind auf der Zielgerade und das Frage- und Antwortespiel der FDA neigt sich dem Ende zu.  

das wurde ja schon mal im September 2020 kommuniziert . Das macht mir aktuell mehr Kopfzerbrechen !! :-)

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Ob wir nächste Woche die 10 Rappen sehen werden?
Was denkt ihr?
Da wollen viele doch noch ihre Positionen abschreiben, solange es noch etwas gibt.  

Das Gesamtpaket und die guten Studienergebnisse passen . :-)

https://finance.yahoo.com/news/...lied-pharma-research-052000691.html

GENEVA, SWITZERLAND / ACCESSWIRE / May 17, 2021 / RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTCQB:RLFTF)("Relief"), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat COVID-19-induced lung injury, is pleased to see the recent announcement by APR Applied Pharma Research S.A. ("APR") regarding the initiation of a pivotal clinical trial with its novel nasal spray, temporarily codenamed APR-AOS2020, a Class III medical device, in patients with mild COVID-19. The trial is designed to evaluate the efficacy and safety of the product in reducing viral load in the upper respiratory airways in recently infected individuals.
 

Allen noch ein schönes Wochenende ! :-)


https://www.medgadget.com/2021/08/...ing-the-period-of-2021-2030.html  

Allen einen guten Start in die Woche !! :-)


https://www.nrxpharma.com/right-to-try/...VjaHAI7_7hK7C4AlKzaLE_iG0tU  

https://ir.nrxpharma.com/news-events/...nces-new-finding-from-zyesami  

https://www.cash.ch/news/boersenticker-firmen/...d-behandlung-1817264

und Acer Therapeutics  :-)

https://www.acertx.com/investor-relations/events-presentations/

https://lnkd.in/gFGwR6WT  

Besten Dank für die raschen Informationen Ineos! Heute mal wieder beachtliches Volumen gehandelt auf der SIX  

 
Ad hoc announcement pursuant to Art. 53 LR  
1

Relief Reports that its U.S. Collaboration Partner has Announced a New Finding
from the ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial Demonstrating Clinically
Significant Relief from Respiratory Distress in Critical COVID-19

Geneva,  Switzerland,  August  31,  2021  –  RELIEF  THERAPEUTICS  Holding  SA  (SIX:  RLF,  OTCQB:  RLFTF)
(“Relief”),  a  biopharmaceutical  company  seeking  to  provide  patients  therapeutic  relief  from  serious
diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner,
NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing an additional
finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with
acute Respiratory Failure due to Critical COVID-19. According to the press release, the new analysis shows
that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved
lung function, within a day of starting treatment. This latest analysis also appears to support NRx's plan
to submit an application for Breakthrough Therapy Designation to the U.S. Food and Drug Administration
for this indication. Relief believes that, if granted, this could confer Priority Review to the aviptadil New
Drug Application, when submitted. The related NRx press release can be accessed through the following
link.

ABOUT RELIEF
Relief  focuses  primarily  on  clinical-stage  programs  based  on molecules with  a  history  of  clinical  testing
and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,  
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders  and  Maple  Syrup  Urine  Disease.  In  addition,  Relief's  recently  completed  acquisitions  of  APR
Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed
and development-stage programs.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the  U.S.  on  OTCQB  under  the  symbol  RLFTF.    For  more  information,  visit  www.relieftherapeutics.com.  
Follow us on LinkedIn.


 
Ad hoc announcement pursuant to Art. 53 LR  
2


CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer  
contact@relieftherapeutics.com

FOR MEDIA/INVESTOR INQUIRIES:  
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com


Disclaimer:  This  communication  expressly  or  implicitly  contains  certain  forward-looking  statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether NRx will provide Relief with the data from its Phase
2b/3  study,  (ii)  whether  Relief  can resolve  its ongoing  dispute with  NRx without  litigation, (iii)  whether
aviptadil will ever be approved in the U.S., UK or the EU for the treatment of respiratory failure in critically
ill patients with COVID-19, and (iv) those risks discussed in Relief's filings with the SIX, which could cause
the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA
to be materially different from any future results, performance or achievements expressed or implied by
such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of
this date and do not undertake to update any forward-looking statements contained herein as a result of
new information, future events or otherwise.
 

Najo so wichtig war die Meldung wohl doch nicht, alle warten auch ich und kaum jemand kauft mehr Anteile dazu.
Ich befürchte meine Spekulation geht nicht auf.  

https://www.nih.gov/news-events/...lasma-covid-19-doesnt-show-benefit  

PR SIX:

Indexanpassungen anlässlich des ordentlichen Indexreviews

Unter Anwendung der Indexreglemente von SMI®, SLI®, SPI®, und SXI®, sowie gestützt auf die Empfehlung der Indexkommission hat das Swiss Index Komitee von SIX über die Indexkorbveränderungen entschieden. Die Indizes werden am 17. September 2021 nach Handelsschluss angepasst, mit Wirkung ab dem 20. September 2021.

Indexkorbveränderungen SXI Bio+Medtech®
Aufnahme in den SXI Bio+Medtech®
RELIEF THERAPEUTICS N    CH0100191136              


https://www.six-group.com/en/newsroom/...s-ordinary-index-review.html  

https://finance.yahoo.com/news/...tics-participate-h-c-123000749.html  

NEWTON, Mass. and GENEVA, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, and RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs). ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).
Based on standard FDA review timelines, Acer expects to receive notification from FDA on the potential acceptance of the NDA for filing within 60 days of submission and subsequent substantive review.

The 505(b)(2) NDA submission is supported by results from two previously announced bioequivalence (BE) trials in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and phenylacetate (PAA), the active metabolite of sodium phenylbutyrate, compared to BUPHENYL® (sodium phenylbutyrate). Acer has also received an Agreement Letter from FDA in response to the Company’s initial Pediatric Study Plan (iPSP) which outlines an agreed upon approach that addresses the needs of pediatric patients with UCDs.

“The submission of our NDA for ACER-001 marks an important step toward bringing this potential alternative treatment option to patients with UCDs,” said Chris Schelling, Chief Executive Officer and Founder of Acer. “We look forward to working with the FDA through the review process and will continue advancing our preparations for a potential launch of ACER-001, while also assisting Relief toward regulatory submissions in Europe.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief Therapeutics, added, “We are excited about the progress made to date in support of a potential regulatory approval of ACER-001 for UCDs in the U.S. With the NDA now submitted, we will continue our efforts to back ACER-001’s development in Europe by targeting submission of a Marketing Authorization Application (MAA) for the treatment of UCDs in Europe by the end of 2021.”

ACER-001 is an investigational product candidate which has not been approved by FDA or the European Medicines Agency (EMA). There is no guarantee that this product candidate will be accepted for substantive review, or if accepted, receive regulatory authority approval in any territory, or become commercially available for the indications under investigation.

About UCDs
UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms. 1,2 The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports , while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication. 3

About ACER-001
ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving de