Posts by KaM

    Und jetzt geht Relief wegen ihm konkurs? Wird nur ein Mensch Relief retten? Ihr seid lustig

    nummelin hat am 17.02.2020 14:07 geschrieben:

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    Stellt euch vor ihr hättet 10 Millionen Relief und sie würden das Mittel zum Coronavirus heraus bringen *dirol* ihr müsstet wahrscheinlich nie mehr arbeiten gehen..... *yahoo*

    Schaut euch mal an was nummelin damals geschrieben hat

    Mir kommt es immer wieder in den Sinn, dass RLF mit grossen Pharmsfirmen agiert und viem Geld einkassieren würde, so dass Rlf100 gar nicht im Markt erscheint, damit die Firmen eigene Produkte vermarkten können oder weiterverkaufen können. Stellt euch vor, wieviel Geld diese bis jetzt mit Corona Geld gemacht haben. Ob das Medi nützt oder nicht, Hauptsache sie machen Geld damit. Wenn Rlf 100 auf den Markt kommt, dann machen die big Players fast keine Kasse mehr, da Rlf gut wirkt und die anderen Medis unnötig wären und aussortiert würde. So meine Meinung.


    Warum ich auf solche Ideen komme: vor ein paar Jahren ist ein Flugzeug von Wissenschaftlern im Bereich HIV über Russland abgestürzt - alle tötlich verunglückt. Ein paar Tage zuvor haben sie an einer Konferenz mitgeteilt, dass sie Medis gegen HIV gefunden hätten...

    Uiii war schon lange nicht da. So viel Phantasie, so viel Träumerei und so viel alles Mögliche, brrrr. Besser auf cash sitzen als auf Aktien. Einer im Forum hat immer wieder geschrieben, dass Gier das Hirn frisst. Da gebe ich ihm vollkommen Recht. Morgen werde ich nochmal einen Teil verkaufen. Ob nun aufwärts oder abwärts spielt keine Rolle mehr. Cash ist cash

    nachhaltig hat am 11.08.2020 08:05 geschrieben:

    Ich frage mich wie viel aktie hast du schon fast jeden tag kaufst du. Über 100mio hast du sicher oder oder bald noch mehr :)

    Hilfe aus der Schweiz für Corona-Patienten?


    Relief Therapeutics mit Sitz in der Schweiz ist aktuell eine der gesuchtesten Aktien an der Börse. Der Grund dafür? Das Pharmaunternehmen hat diese Woche vielversprechende News verbreitet: "Klinische Studie mit RLF-100 (Aviptadil) zeigt rasche Regeneration bei Lungenversagen sowie eine gehemmte Vermehrung des Coronavirus in menschlichen Lungenzellen."


    https://herisau24.ch/articles/…eiz-fuer-corona-patienten

    100000 Stück habe ich verkauft. So habe ich mein Eigen geld rausgeholt. Wir besitzen immer noch 3 Mio. Aktien. Das ist dann der Reingewinn. Warscheinlich nächste woche werde ich sie los.

    RLF-100 (aviptadil) clinical trial showed rapid recovery from respiratory failure and inhibition of coronavirus replication in human lung cells

    • Rapid recovery of patients on ventilators and ECMO (extracorporeal membrane oxygenation) was seen in patients with severe medical comorbidities after three days of treatment with RLF-100 under FDA Emergency Use IND authorization at multiple clinical sites.
    • RLF-100 is being developed as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes
    • 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, CH, August 3, 2020 – NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF) “Relief” today announced that RLF-100 (aviptadil) showed rapid recovery from respiratory failure in the most critically ill patients with COVID-19. At the same time, independent researchers have reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes.


    RLF-100 has been granted Fast Track designation by FDA and is being developed as a Material Threat Medical Countermeasure in cooperation with the National Institutes of Health and other federal agencies. Further research will be conducted.


    The first report of rapid clinical recovery under emergency use IND was posted by doctors from Houston Methodist Hospital. The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days.[1] Similar results were subsequently seen in more than 15 patients treated under emergency use IND and an FDA expanded access protocol which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial.


    Patients with Critical COVID-19 were seen to have a rapid clearing of classic pneumonitis findings on x-ray, accompanied by an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.[2] clinicaltrials.gov NCT04311697.


    The clinical findings may be based on evidence that VIP inhibits the replication of the SARS-CoV-2 virus in human lung cells and immune cells (monocytes). The work was reported by Brazilian researchers working in a level-4 biocontainment laboratory.[3] The same researchers reported a case-control study in which patients who survived being on ventilators for COVID-19 had significantly higher levels of VIP in their blood than those who died of respiratory failure.


    “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.”


    FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19

    • Expanded access protocol, including for pregnant women, is becoming available to patients who are ineligible for enrollment in the FDA clinical trial of RLF-100,
    • RLF-100, a patented formulation of Aviptadil, is currently in development by NeuroRx and RELIEF THERAPEUTICS Holding AG under Fast Track Designation, and recently obtained positive safety opinion from the data monitoring committee.


    Geneva and Radnor, PA, July 29, 2020 – RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTC:RLFTF) “Relief” and its U.S. partner, NeuroRx, Inc. today announced that FDA has granted an Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP). The protocol makes treatment available to patients who have exhausted standard therapies and are not eligible for the current phase 2/3 trial of RLF-100 because of confounding medical conditions and specifically makes the treatment available to pregnant women. Although the drug remains under investigation, rapid recovery from respiratory failure in COVID-19 has been seen in patients treated under FDA Emergency Use authorization.[1]


    The expanded access protocol may be viewed on www.clinicaltrials.gov NCT04453839. Physicians who wish to enroll their patients in the protocol must submit the protocol to their local investigational review board and file FDA form 1572 with NeuroRx, Inc. Further information may be obtained from expandedaccess@neurorxpharma.com.



    “By granting this Expanded Access protocol, FDA has made a potentially lifesaving drug immediately available to critically ill patients who have no other available treatment,” said Dr. Jonathan C. Javitt, MD, MPH, NeuroRx’s CEO. “We thank the FDA’s pulmonary division for its rapid and proactive implementation of the Coronavirus Treatment Acceleration Program, and we aspire to demonstrate broad safety and efficacy for RLF-100 in our ongoing clinical trial.”


    The SARS-CoV-2 coronavirus that causes COVID-19 attacks the body by entering the small population of Alveolar Type II cells in the lung.[2] Without Type II cells, the lung cannot transmit oxygen, which why the coronavirus causes acute respiratory failure. 50 years of scientific research demonstrates that VIP binds specifically to the Type II cell and protects that cell against cytokines (inflammatory molecules) and a wide array of toxic and infectious injuries.”[3]




    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 rational. 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[4] 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 (ISIN: CH0100191136).




    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.



    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


    European Inquiries:
    Yves Sagot, Ph.D.
    Relief Therapeutics Holding, SA
    yves.sagot@relieftherapeutics.com


    MEDIA CONTACT


    David Schull
    Russo Partners, LLC
    david.schull@russopartnersllc.com
    858-717-2310


    INVESTOR RELATIONS


    Brian Korb
    Solebury Trout
    bkorb@troutgroup.com
    917-653-5122


    [1] Youssef JG, Rapid Clinical Recovery from Critical COVID-19 with Respiratory Failure in a Lung Transplant Patient Treated with Intravenous Vasoactive Intestinal Peptide doi: 10.20944/preprints202007.0178.v1


    [2] Mason R. Pathogenesis of COVID-19 from a Cell Biologic Perspective. Eur Respir J. April 9 Epub ahead of print. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7144II60/


    [3] https://www.authorea.com/users/321659/articles/472151-vasoactive-intestinal-peptide-treats-respiratory-failure-in-covid-19-by-rescuing-the-alveolar-type-ii-cell


    [4] US 8,178,489 Formulation for Aviptadil

    RELIEF THERAPEUTICS Holding SA to agree share settlement for an outstanding CHF 1’723’300 debt position provided by GEM


    Geneva (Switzerland), July 16, 2020


    RELIEF THERAPEUTICS Holding SA (SIX:RLF) ("Relief" or the "Company") announces that it has entered into a binding agreement (the “Agreement”) with Gem Global Yield Fund LLC (“GEM”), the largest single shareholder in RLF, relating to an outstanding debt position in a total amount of CHF 1’723’300 that is repayable on demand. Under the terms of this Agreement, RLF and GEM have agreed on the redemption of the outstanding CHF 1’723’300 debt position in newly issued RLF Shares.


    The attribution price corresponds to CHF 0.0297, representing a 10% discount to the closing price of the trading of the RLF Shares on SIX Swiss Exchange on 14 July 2020 of CHF 0.033. As a result, GEM will be receiving receive 58’023’584 RLF Shares at closing of the transaction, issued from existing authorized capital of the company. Closing of the transaction is expected to occur by the end of July 2020.



    About RELIEF THERAPEUTICS Holding SA


    RELIEF THERAPEUTICS Holding SA is a clinical stage biotechnology company with a portfolio of drug candidates derived from natural human origins. Its most promising drug candidate is Aviptadil, alias vasoactive intestinal peptide, for the treatment of Acute Respiratory Distress Syndrome (ARDS) and pulmonary sarcoidosis. With the support of its American partner NeuroRx, RELIEF THERAPEUTICS Holding SA is testing Aviptadil in two phase II/III trials on COVID-induced ARDS19 (NCT04311697 and NCT04360096). Aviptadil development in pulmonary sarcoidosis will focus on chronic sarcoidosis, an orphan disease market.



    RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF.


    For further information, please visit the Company's website at www.relieftherapeutics.com or contact investor relations at: investors@relieftherapeutics.com.

    NeuroRx and Relief Therapeutics announce Data Monitoring Committee determination to continue phase 2/3 trial of
    RLF-100 for Critical COVID-19

    • With resurgent COVID-19, enrollment has accelerated in Miami, Houston, and Irvine
    • Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns that would mandate stopping. The study is to continue until the next scheduled data review in four weeks.
    • Primary endpoint is established as “Alive and free of Respiratory Failure.”

    Radnor, PA and Geneva July 16, 2020 – NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holdings AG (OTC:RLFTF, SIX:RLF) today announced that the independent Data Monitoring Committee has reviewed the findings in the first 30 patients treated in Fast Track FDA trials of RLF-100 (Aviptadil) in patients with Critical COVID-19 with respiratory failure.


    The study protocol enrolls patients with Critical COVID-19 and Respiratory Failure and randomly assigns them to intravenous RLF-100 or Placebo in the hopes of achieving remission from this most-serious stage of COVID-19. At the committee’s recommendation, the primary endpoint is changed to “alive and free of respiratory failure at 7-10 days.” This change in primary endpoint from mortality at 28 days is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by initial observations in the clinical trial.


    This first interim analysis was focused on verifying the apparent safety of the drug in the first 30 patients and the feasibility of the study to reach its endpoint. The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks.


    The committee is composed of Prof. Alfred Sommer, MD, MHS, Dean Emeritus of the Johns Hopkins Bloomberg School of Public Health, Prof. Rita Colwell, PhD, former Director of the National Science Foundation, and Congressman, Andy Harris, MD, MHS (MD District 1) a part time Professor of Anesthesia and Critical Care at Johns Hopkins School of Medicine.


    RLF-100 (Aviptadil) received Fast Track designation from the US FDA for the treatment of Critical COVID-19 with respiratory failure. Aviptadil is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which is known to protect the Alveolar Type II cell of the lung from many forms of injury. This cell is critical to transmission of oxygen to the blood and is the site of attack for the Coronavirus.


    “This milestone represents the extraordinary effort of our partners and collaborators at the University of Miami, Houston Methodist Hospital, UC Irvine, and University of Louisville who gave 100% to providing patients with Critical COVID-19 a chance to benefit from a potentially life-saving drug. We thank the members of the Data Monitoring Committee for devoting their valuable time to performing this vital role in helping to evaluate the safety and effectiveness of RLF-100,” said Prof. Jonathan C Javitt, MD, MPH, CEO of NeuroRx and the National Study Chair.


    Details of the study are posted on clinicaltrials.gov NCT04311697.

    Ihr redet vom der Zulassung. Kann jemand mir erklären, warum die Aktien seit Tagen in die gleiche Richtung geht? Warum verkaufen die Leute wie verrückt? Dahinter muss etwas sein. Oder nicht?


    Was meint der @Goldi :)

    2 neue studien Orte und beide sind (Recruiting)


    United States, Kentucky
    University of Louisville
    [Recruiting]
    Louisville, Kentucky, United States, 40202
    Contact: Rainer Lenhardt, MD 502-562-3000 rainer.lenhardt@louisville.edu
    Principal Investigator: Rainer Lenhardt, MD
    United States, Texas
    Houston Methodist Hospital
    [Recruiting]
    Houston, Texas, United States, 77030
    Contact: Jihad Georges Youssef, MD 713-441-3948 jgyoussef@houstonmethodist.org
    Principal Investigator: Jihad Georges Youssef, MD

    nachhaltig hat am 29.06.2020 20:17 geschrieben:

    Quote

    Da würden wir reich werden bei einer Zulassung von RLF-100! Ungefährer Richtpreis pro Behandlung um die 2000 Dollar^^


    Remdesivir-Behandlung soll 2340 Dollar pro US-Patient kosten

    Wo hast du diese news gelesen? Wo ist die Quelle deiner Aussage?

    Was für ein Tag - auf einer Achterbahn sind wir. Zuerst 20 plus - danach minus und jetzt wieder bergaufwärts. Wirs mir fast schwindlig. So viel Adrenalin an einwm Tag ist nicht gesund für die Nerven...

    NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19

    • Fast Track Designation of RLF-100 for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19 underscores the urgent need for new treatment options for these patients.
    • At FDA S request, NeuroRx is submitting an expanded access policy enabling physicians to request RLF-100 for patients who meet this criterion.

    Radnor, PA and Geneva June 2, 2020 - NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19. RLF-100 is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which reduces inflammation in the lungs and protects the alveolar type II cells that are believe to be an entry route for the SARS-CoV-2 to invade the lungs.


    As part of NeuroRx's enrollment in the Fast Track program, the FDA has requested that NeuroRx submit a publicly-available expanded access policy, so that physicians may request RLF-100 for their patients who are being treated in hospitals not participating in the ongoing Phase 2/3 clinical trials.


    “We at NeuroRx are enormously appreciative of the FDA's commitment to accelerating the development of any potential treatment for COVID-19. We hope to live up to the trust that has been placed in us by bringing a life-saving treatment to patients,” said Prof. Jonathan Javitt, MD, MPH, CEO and Chairman of NeuroRx.


    This milestone demonstrates the effectiveness of the FDA CoronaVirus Treatment Acceleration Program and the FDA's achievement in rising up to address the most severe Public Health Crisis of our lifetime”. said former FDA Chief Counsel, Daniel Troy, a member of the Company's board of directors.


    RLF-100 is being tested in Phase 2/3 clinical trials at major medical centers including the University of Miami, Houston Methodist Hospital, University of California-Irvine, the NYU Langone Medical Center, and the Rambam Healthcare Campus (Haifa, Israel). The multicenter clinical trial enrolls patients with Critical COVID-19 and respiratory failure in the hopes that RLF-100 can decrease mortality and improve blood oxygenation in this condition by rescuing alveolar type II cells from the SARS-CoV-2 virus.


    Details of the study are posted on clinicaltrials.gov NCT04311697.


    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 primarily concentrated in the lung and is known to protect against a variety of lung injuries. VIP was awarded Orphan Drug Designation in 2001 by the U.S. FDA for treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. The European Medicines Agency awarded orphan drug designation in 2006 for the treatment of acute lung injury and in 2007 for the treatment of sarcoidosis.


    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, that is critical to 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. Corona Viruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. 2 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 are essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.


    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 rational. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.


    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.


    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


    Jonathan C. Javitt, M.D., MPH


    Chief Executive Officer


    NeuroRx, Inc.


    ceo@neurorxpharma.com


    Yves Sagot, Ph.D.


    Relief Therapeutics Holding, SA


    yves.sagot@relieftherapeutics.com


    MEDIA CONTACT


    Gloria Gasaatura


    LifeSci Communications


    ggasaatura@lifescicomms.com


    646-970-4688

    Relief Therapeutics - Fondation EIP Bâtiment F2/F3

    20.06.2020 00:12


    Novartis stoppt Studie mit Malaria-Mittel gegen Covid-19


    Basel (awp/sda/reuters) - Der Basler Pharmakonzern Novartis stoppt seine klinische Studie mit dem Malariamittel Hydroxychloroquine zur Behandlung der vom Coronavirus ausgelösten Erkrankung.


    Grund sei ein Mangel an Teilnehmern, teilt das Unternehmen mit. Die US-Arzneimittelbehörde FDA hatte die Studie im April genehmigt. An den Tests sollten rund 440 mit dem Erreger infizierte, ins Spital eingelieferte Patienten teilnehmen.


    Am Montag zog die FDA allerdings ihre Notfall-Genehmigung für den Einsatz des Malariamittels zurück. Auf Basis neuer Studien könne man nicht länger davon ausgehen, dass das oral verabreichte Mittel bei der Lungenerkrankung wirke, teilte die FDA mit.

    Relief Therapeutics and NeuroRx Expand Clinical Trial
    of RLF-100 to all patients with Critical COVID-19 and Respiratory Failure


    • Clinical trial expanded to patients treated with both noninvasive and mechanical ventilation in Critical COVID-19.
    • Clinical trial to enroll 144 patients total with expansion to additional sites
    • RLF-100 is a patented formulation of Aviptadil (synthetic human Vasoactive Intestinal Polypeptide VIP), which inhibits pro-inflammatory cytokines and protects alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Type 2 cells are essential to oxygen exchange and are preferentially targeted by the SARS-CoV-2 virus


    Geneva and Radnor, PA, June 8, 2020 – RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” and its U.S. partner, NeuroRx, Inc. today announced that the phase 2/3 clinical trial evaluating RLF-100 as a treatment for Critical COVID-19 with Respiratory Failure has been expanded to include patients receiving high flow oxygen and noninvasive ventilation (CPAP), in addition to those on ventilators. RLF-100 (Aviptadil) is a patented formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which has been granted Orphan Drug Designation by the US FDA in Acute Respiratory Distress Syndrome and chronic lung diseases.


    “With the FDA’s expanded definition of Critical COVID-19 to include patients on all forms of ventilation and the recent trend at leading hospitals that avoids mechanical ventilators whenever possible for patients with COVID-19, we recognized the potential benefit of extending this clinical trial to patients on newer forms of treatment for respiratory failure,” said Dr. Jonathan C. Javitt, MD, MPH, NeuroRx’s CEO and the National Study Chair.


    “The SARS-CoV-2 attacks the body by entering the small population of Alveolar Type II cells in the lung, almost like hitting the needle in the haystack.[1] Without Type II cells, the lung cannot transmit oxygen, which is exactly what happens in COVID-19. We know, from 50 years of scientific research that VIP binds specifically to the Type II cell and protects that cell against cytokines (inflammatory molecules) and a wide array of toxic and infectious injuries.[2]


    The multicenter clinical trial will enroll patients with Critical COVID-19 and respiratory failure in the hopes that RLF-100 can decrease mortality and improve blood oxygenation in this condition by rescuing alveolar type II cells from the SARS-CoV-2 virus.


    “In recent months, there has been significant focus on “cytokine storm” as a mechanism of death in COVID-19 and on the use of various anti-inflammatory drugs to block cytokines,” said Dr. Javitt. “While cytokine storm is certainly a consequence of the corona virus infecting the Type-II alveolar cells, we are hopeful that a more targeted approach to blocking the effects of the Corona Virus may stop the cytokine storm at an earlier stage.”


    The trial is being led by NeuroRx, Inc., the US development partner of Relief Therapeutics, whose clinical operations are based in Radnor, PA. Patients are being treated under FDA Investigational New Drug clearance, as part of the FDA’s Corona Treatment Acceleration Program (CTAP). Details of the study are posted on clinicaltrials.gov NCT04311697.