$RLFTF Various DD (copied) FDA grants inhaled
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Posted On: 08/09/2020 5:31:12 AM
$RLFTF Various DD (copied)
FDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure
- Aviptadil is now shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung
- RLF-100 is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA Fast Track Designation, FDA emergency use IND authorization, and an expanded access protocol.
RADNOR, Pa. and GENEVA,
Aug. 6, 2020 /PRNewswire/ -- NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF) "Relief" today announced that NeuroRx has been granted Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure.
The study is posted at https://clinicaltrials.gov/ct2/show/NCT04360096. The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure. If promising results are seen in the inpatient setting, the trial will expand to patients at home with mild and moderate COVID-19 in order to prevent the need for hospital admission.
Professor Jonathan Javitt, MD, MPH, CEO of NeuroRx said, "Now that we know VIP suppresses replication of the SARS-CoV-2 virus in human lung cells, based on the outstanding work of the Oswaldo Cruz Institute (Rio de Janeiro).1 We are optimistic that treatment with VIP will not only help patients on ventilators, but will help to stop the advancement of the virus in patients with earlier stages of COVID-19. By blocking cytokine synthesis in the lung cells and increasing the production of surfactant, which is key to the lung's ability to transmit oxygen, we are hopeful that inhaled VIP will prove to be of clinical benefit across a wider array of patients suffering respiratory complications from COVID-19 infection."
The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before September 1, 2020.
About VIP in Lung Injury
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the Alveolar Type II cell, which is critical for the transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.
COVID-19-related death is primarily caused by respiratory failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.
Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.
About RLF-100
RLF-100 (aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Dr. Said's original work and was originally approved for human trials by the FDA in 2001 and the European Medicines Agency in 2005. VIP is known to be highly concentrated in the lungs and to inhibit a variety of inflammatory cytokines. Relief's predecessor company, Mondo Biotech, was awarded Orphan Drug Designation in 2001 by the U.S. FDA for aviptadil in the treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. Mondo was awarded Orphan Drug Designation by the European Medicines Agency in 2006 for the treatment of acute lung injury and in 2007 for the treatment of sarcoidosis. Both Mondo and Relief have worked on development of an inhaled formulation of aviptadil for several years. Both the U.S. FDA and the EMEA have granted Investigational New Drug licenses for human trials of aviptadil.
About RELIEF THERAPEUTICS Holding AG
The Relief group of companies focus primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.
Relief Therapeutics holds orphan drug designations from the U.S. Food and Drug Administration and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief Therapeutics also holds a U.S. patent (US8178489 formulation for aviptadil) for RLF-100 and proprietary manufacturing processes for its synthesis.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF.
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 for the treatment of suicidal bipolar depression and is currently in Phase 3 trials. Its Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
CORPORATE CONTACTS
US Inquiries
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com
Europe Inquiries
Yves Sagot, Ph.D.
Chief Scientific Officer
Relief Therapeutics Holding AG
yves.sagot@relieftherapeutics.com
MEDIA CONTACT
US - David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
Europe - Raimund Gabriel, Laurie Doyle
MC Services AG
Neurorx@mc-services.eu
+49 89 210 228 0
INVESTOR RELATIONS
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122
1
Temerozo JR, Sacramenta Q, Fintelman-Rodriques N, et. al. The neuropeptides VIP and PACAP inhibit SARS-CoV-2 replication in monocytes and lung epithelial cells, decrease the production of proinflammatory cytokines, and VIP levels are associated with survival in severe Covid-19 patients doi: https://doi.org/10.1101/2020.07.25.220806. https://www.biorxiv.org/content/10.1101/2020....806v2.full
https://c212.net/c/img/favicon.png?sn=NY84514...2020-08-06 View original content:http://www.prnewswire.com/news-releases/fda-grants-inhaled-use-ind-for-rlf-100-aviptadil-to-treat-patients-with-moderate-and-severe-covid-19-aiming-to-prevent-progression-to-respiratory-failure-301107288.html
SOURCE NeuroRx, Inc; Relief Therapeutics Holding AG
https://www.otcmarkets.com/stock/RLFTF/news/s...id=1663433
----
Life Saving RLF-100
https://arizonadailyindependent.com/valley-hu...-covid-19/
----
Fox News link! https://video.foxbusiness.com/v/6178856365001/#sp=show-clips
---
Awesome find Andy2018
A few excerpts from comments by the Chairman
On safety of the drug
Quote:
The active pharmaceutical ingredient of Aviptadil has been used for a lot of years in different indications. From a safety standpoint we are quite optimistic.
On the efficacy of the drug
Quote:
It is very challenging to treat this disease and rare to identify a therapy that actually can have an impact...There is now first evidence that Relief's drug is working...the fact that we have been fortunate enough to move a clinical program ahead very quickly: We have now started to see evidence that the drug is working. Many other people have tried things in Covid-19 and didn't get very far...I would say the probability at the moment stands at 60 to 70% that we will get the drug approved.
On financing
Quote:
There are effectively two trials: For the one we are currently running the total budget will be in the range of CHF 7 to 8 mio. The Inhaled study we just got approval to start will probably cost between CHF 10 and 15 mio....We have access to a share subscription facility from which we can draw...We have already spent close to CHF 4 mio. on the trials, and we currently have close to CHF 3 mio.
on Top-line results
Quote:
it would only take us a few more months to get to the point where we would be able to report top-line results from this trial.
On revenues
Quote:
it could generate hundreds of millions of dollars per year during that timeframe...Aviptadil is our drug...That is the current situation.
A 60% 70% probability of approval is pretty high. I wonder if any other CEOs of the Covid-19 companies have said or can say this. I've not personally seen. Upon approval, sky is the limit for pps. I also believe our CEO is being cautious and conservative.
https://themarket.ch/interview/relief-therape...ar-ld.2478
$RLFTF
Disclaimer: Just my opinion of course, do your ow DD.
mikar : "No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication," said Prof. Jonathan Javitt, CEO and Chairman of NeuroRx. "We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month."
Agreed again. Read here:
Quote:
Independent research has found RFL-100 can block COVID-19's replication in human lung cells and monocytes; no other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication, says Jonathan Javitt, CEO, NeuroRx
https://www.businesstoday.in/coronavirus/coro...12306.html
RLFTF
Imho only
FDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure
- Aviptadil is now shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung
- RLF-100 is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA Fast Track Designation, FDA emergency use IND authorization, and an expanded access protocol.
RADNOR, Pa. and GENEVA,
Aug. 6, 2020 /PRNewswire/ -- NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF) "Relief" today announced that NeuroRx has been granted Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure.
The study is posted at https://clinicaltrials.gov/ct2/show/NCT04360096. The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure. If promising results are seen in the inpatient setting, the trial will expand to patients at home with mild and moderate COVID-19 in order to prevent the need for hospital admission.
Professor Jonathan Javitt, MD, MPH, CEO of NeuroRx said, "Now that we know VIP suppresses replication of the SARS-CoV-2 virus in human lung cells, based on the outstanding work of the Oswaldo Cruz Institute (Rio de Janeiro).1 We are optimistic that treatment with VIP will not only help patients on ventilators, but will help to stop the advancement of the virus in patients with earlier stages of COVID-19. By blocking cytokine synthesis in the lung cells and increasing the production of surfactant, which is key to the lung's ability to transmit oxygen, we are hopeful that inhaled VIP will prove to be of clinical benefit across a wider array of patients suffering respiratory complications from COVID-19 infection."
The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before September 1, 2020.
About VIP in Lung Injury
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the Alveolar Type II cell, which is critical for the transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.
COVID-19-related death is primarily caused by respiratory failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.
Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.
About RLF-100
RLF-100 (aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Dr. Said's original work and was originally approved for human trials by the FDA in 2001 and the European Medicines Agency in 2005. VIP is known to be highly concentrated in the lungs and to inhibit a variety of inflammatory cytokines. Relief's predecessor company, Mondo Biotech, was awarded Orphan Drug Designation in 2001 by the U.S. FDA for aviptadil in the treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. Mondo was awarded Orphan Drug Designation by the European Medicines Agency in 2006 for the treatment of acute lung injury and in 2007 for the treatment of sarcoidosis. Both Mondo and Relief have worked on development of an inhaled formulation of aviptadil for several years. Both the U.S. FDA and the EMEA have granted Investigational New Drug licenses for human trials of aviptadil.
About RELIEF THERAPEUTICS Holding AG
The Relief group of companies focus primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.
Relief Therapeutics holds orphan drug designations from the U.S. Food and Drug Administration and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief Therapeutics also holds a U.S. patent (US8178489 formulation for aviptadil) for RLF-100 and proprietary manufacturing processes for its synthesis.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF.
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 for the treatment of suicidal bipolar depression and is currently in Phase 3 trials. Its Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
CORPORATE CONTACTS
US Inquiries
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com
Europe Inquiries
Yves Sagot, Ph.D.
Chief Scientific Officer
Relief Therapeutics Holding AG
yves.sagot@relieftherapeutics.com
MEDIA CONTACT
US - David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
Europe - Raimund Gabriel, Laurie Doyle
MC Services AG
Neurorx@mc-services.eu
+49 89 210 228 0
INVESTOR RELATIONS
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122
1
Temerozo JR, Sacramenta Q, Fintelman-Rodriques N, et. al. The neuropeptides VIP and PACAP inhibit SARS-CoV-2 replication in monocytes and lung epithelial cells, decrease the production of proinflammatory cytokines, and VIP levels are associated with survival in severe Covid-19 patients doi: https://doi.org/10.1101/2020.07.25.220806. https://www.biorxiv.org/content/10.1101/2020....806v2.full
https://c212.net/c/img/favicon.png?sn=NY84514...2020-08-06 View original content:http://www.prnewswire.com/news-releases/fda-grants-inhaled-use-ind-for-rlf-100-aviptadil-to-treat-patients-with-moderate-and-severe-covid-19-aiming-to-prevent-progression-to-respiratory-failure-301107288.html
SOURCE NeuroRx, Inc; Relief Therapeutics Holding AG
https://www.otcmarkets.com/stock/RLFTF/news/s...id=1663433
----
Life Saving RLF-100
https://arizonadailyindependent.com/valley-hu...-covid-19/
----
Fox News link! https://video.foxbusiness.com/v/6178856365001/#sp=show-clips
---
Awesome find Andy2018
A few excerpts from comments by the Chairman
On safety of the drug
Quote:
The active pharmaceutical ingredient of Aviptadil has been used for a lot of years in different indications. From a safety standpoint we are quite optimistic.
On the efficacy of the drug
Quote:
It is very challenging to treat this disease and rare to identify a therapy that actually can have an impact...There is now first evidence that Relief's drug is working...the fact that we have been fortunate enough to move a clinical program ahead very quickly: We have now started to see evidence that the drug is working. Many other people have tried things in Covid-19 and didn't get very far...I would say the probability at the moment stands at 60 to 70% that we will get the drug approved.
On financing
Quote:
There are effectively two trials: For the one we are currently running the total budget will be in the range of CHF 7 to 8 mio. The Inhaled study we just got approval to start will probably cost between CHF 10 and 15 mio....We have access to a share subscription facility from which we can draw...We have already spent close to CHF 4 mio. on the trials, and we currently have close to CHF 3 mio.
on Top-line results
Quote:
it would only take us a few more months to get to the point where we would be able to report top-line results from this trial.
On revenues
Quote:
it could generate hundreds of millions of dollars per year during that timeframe...Aviptadil is our drug...That is the current situation.
A 60% 70% probability of approval is pretty high. I wonder if any other CEOs of the Covid-19 companies have said or can say this. I've not personally seen. Upon approval, sky is the limit for pps. I also believe our CEO is being cautious and conservative.
https://themarket.ch/interview/relief-therape...ar-ld.2478
$RLFTF
Disclaimer: Just my opinion of course, do your ow DD.
mikar : "No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication," said Prof. Jonathan Javitt, CEO and Chairman of NeuroRx. "We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month."
Agreed again. Read here:
Quote:
Independent research has found RFL-100 can block COVID-19's replication in human lung cells and monocytes; no other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication, says Jonathan Javitt, CEO, NeuroRx
https://www.businesstoday.in/coronavirus/coro...12306.html
RLFTF
Imho only
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