Posts by KaM

    Relief Therapeutics announces filing of IND for Phase 2/3 Clinical Trial of inhaled RLF-100 targeting early COVID-19 Lung Injury

    • Study to enroll 144 patients with COVID-19-associated non-acute lung injury in an attempt to decrease progression to Acute Respiratory Distress Syndrome and need for ICU care
    • RLF-100, a patented formulation of Aviptadil (synthetic human Vasoactive Intestinal Polypeptide), binds alveolar type 2 cells in the lung. Type 2 cells are essential to oxygen exchange and are selectively targeted by the SARS-CoV-2 virus
    • Inhaled VIP may prevent viral destruction of type 2 cells, which could reduce fatal pulmonary complications of COVID-19


    Geneva. May 11, 2020 – RELIEF THERAPEUTICS Holding AG (SIX:RLF) (Relief) today announced that its U.S. partner, NeuroRx Inc., has filed an investigational protocol with the U.S. Food and Drug Administration under the Coronavirus Treatment Acceleration Program (CTAP) to conduct a Phase 2/3 clinical trial assessing inhaled (RLF-100) as a treatment for patients with non-acute lung injury caused by the SARS-CoV-2 virus (COVID-19). RLF-100 is a patented formulation of Aviptadil, a synthetic human vasoactive intestinal polypeptide (VIP). VIP is known from numerous animal models of lung injury and lung disease to inhibit inflammatory cytokines and to protect pulmonary epithelial cells that line the air sacs (alveolae) of the lung.


    Recent findings suggest that the type-2 alveolar cells are particularly vulnerable to coronavirus because of cell surface receptors that allow the virus to enter the cell. The type-2 cells are essential to replenishing the pulmonary epithelium and to manufacturing surfactant, which coats the inside of the lung and allows oxygen exchange to occur. Without surfactant, the alveolae do not stay open and blood oxygen drops quickly, as is seen in patients with COVID-19.


    RLF-100 is already in clinical trials for the treatment of Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients on mechanical ventilation. Currently, four out of five patients who progress to this acute, severe, stage of COVID-19 disease are reported to die despite maximum intensive care.


    The early stage of COVID-19 is different from more familiar viral pneumonia in its characteristic hypoxia (low blood oxygen) in advance of the devastating cytokine storm that too frequently leads to death,” said Jonathan Javitt, M.D., MPH, founder and CEO of NeuroRx. “Our clinical trial partners have asked us to develop a treatment approach for patients presenting with early lung injury in the hopes of preventing progression to ICU care and mechanical ventilation. VIP is heavily concentrated in the lung and plays a critical role in the body’s natural defense against many lung injuries, ranging from infectious to chemical substances to smoke inhalation. VIP is known to preferentially bind the precious type 2 cells in the lung that are directly attacked by the coronavirus. While there are many drugs being tested in the clinic today against specific cytokines (such as IL-6), we believe RLF-100 is the only drug candidate that specifically targets the pulmonary cells attacked in COVID-19 lung injury and the only experimental drug that targets the broad array of inflammatory cytokines produced during SARS-CoV-2 infection.”


    The multicenter randomized placebo-controlled trial aims to enroll 144 patients with COVID-19 with shortness of breath and early pulmonary symptoms in an effort to slow COVID-19 progression. Because these patients can still breathe on their own, RLF-100 will be inhaled, rather than injected, a dosage form that is suitable both for home and hospital use. Inhaled dosing allows delivery of RLF-100directly to the lung tissue most at risk from the coronavirus.


    The trial will be conducted in at least 20 sites. Patients will be randomized to receive inhaled RLF-100 plus standard of care or placebo plus standard of care. The primary endpoints will be progression to ARDS over 28 days and improvement in blood oxygenation. Secondary endpoints will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα, IL-6 and other cytokines.


    Details of the clinical trial protocol may be viewed on the government’s website www.clinicaltrials.gov (NCT04360096).


    About VIP in Lung Injury


    Vasoactive Intestinal Polypeptide (VIP) was first characterized by the late Dr. Sami Said in the 1970s. Although first identified in the intestinal tract, VIP is now known to be manufactured throughout the body and to be heavily 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. 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 Acute Respiratory Distress Syndrome (ARDS). The trigger for ARDS is widely attributed to a cytokine storm in the lungs, in which the virus causes release of inflammatory molecules called cytokines. As a result, the air sacs (alveolae) of the lungs to fill with water and become impermeable to oxygen, even in the setting of mechanical ventilation. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells.[1] These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors on their cell membranes, which are bound by the SARS-CoV-2 virus and serve as the route of entry for the virus into the cells. Although not yet shown for COVID-19, the coronavirus that causes SARS (SARS-CoV) is 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 theory that VIP specifically protects these cells from injury.


    Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression. 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. Patients with early COVID-19 lung injury commonly describe “crackling sounds” in their lungs, combined with extreme shortness of breath. No currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.

    Relief Therapeutics Holding (RLF:SIX) drug Aviptadil enters FDA trial at University of California Irvine, to treat COVID-19-induced Acute Respiratory Distress


    Aviptadil targets the cytokine storm that causes fatal Respiratory Distress in COVID-19


    Geneva, Switzerland

    • Coronavirus (COVID-19) death is primarily caused by Acute Respiratory Distress Syndrome (ARDS), in which severe inflammation causes the lungs to fill with fluid and even mechanical ventilation is unable to maintain life. The syndrome is caused, in part, by a Cytokine Storm unleashed by viral particles.
    • VIP has been shown to have potent anti-cytokine effects in numerous animal models and in phase 1 and phase 2 human studies

    RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” announces that the University of California, Irvine is participating in the Phase 2 clinical study of its drug Aviptadil for the treatment of Acute Respiratory Distress Syndrome (ARDS) in COVID-19. The multicenter trial will enroll patients who are already on mechanical ventilation in the hopes that Aviptadil can decrease mortality in this condition and help to improve the ability of the patient’s lungs to transfer oxygen to the body.


    “We are very pleased to be one of the first centers launching the clinical study of Aviptadil in patients with COVID-19 induced Acute Respiratory Distress (ARDS). This study focuses on patients receiving mechanical ventilation and hence maximal conventional intensive care, and for which mortality is alarmingly high. If successful, we hope that treatments such as Aviptadil may change the chances of survival for these patients.” said Richard Lee, MD, Interim Chief of the Division of Pulmonary Diseases and Critical Care Medicine at UCI Medical Center, who is serving as principal investigator for this site.


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


    Death in COVID-19-infected patients is caused in part by a “cytokine storm” in the lungs, in which the virus triggers inflammatory molecules called “cytokines,” which cause the air sacs (alveolae) of the lungs to fill with water and become impermeable to oxygen, even in the setting of mechanical ventilation. Emerging data from clinical centers in the Northeast of the USA points to the mortality of 80%-90% in patients currently receiving mechanical ventilation. VIP is a naturally synthesized peptide which is 40% concentrated in the lungs and which has been shown to have a potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury, and inflammation. It has a 20-year history of safe use in human beings in multiple human trials for sarcoidosis, pulmonary fibrosis, and pulmonary hypertension, and is marketed in Europe as a local injection to treat erectile dysfunction.


    Relief Therapeutics holds FDA and EU orphan drug designations for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a US patent[1] for Aviptadil and proprietary manufacturing processes for its synthesis.


    “In a previous trial of VIP for ARDS in patients with sepsis, 7 of 8 patients on mechanical ventilation showed substantial improvement and 6 ultimately left the hospital alive,” said Prof. Jonathan Javitt, MD, MPH, the CEO of NeuroRx, Inc. “Patients on ventilators for COVID-19 have only small chance of survival. If the early results can be replicated in ARDS caused by COVID-19, this treatment could have a major impact both on COVID-19 survival and on the availability of ventilators for those in desperate need.”

    Ihr Experten, habt die ganze Woche auf die News gewartet. Seid ihr nun zufrieden mit den News? Ihr Experten, was erwartet uns Montag? Rot oder Schwarz? :)

    Damals war hier sehr schon ruhig nur @Goldi hat geschrieben und noch ein paar andere. Seit zwei Monaten gleicht es hier in diesem Forum einem Müllcontainer. Eigentlich wollte ich gar nicht schreiben, konnte mich jedoch nicht zurückhalten. Ich will nur @Goldis Spiel mitmachen. Ich sage, Morgen wird es mit 0,0282 beginnen, danach wird es nur noch aufwärts gehen. Ihr seid mit nichts zufrieden egal ob es rauf oder runter geht, findet ihr immer etwas zum Motzen ;)

    Wenn ich es richtig verstehe,

    Wenn ich es richtig verstehe, laufen an 4 verschiesenen Orten die studien ab.


    Contacts/Locations

    Central Contact: Robert E Besthof, MIM
    Telephone: +14842546134 Ext. 701
    Email: rbesthof@neurorxpharma.com
    Study Officials: Jonathan C Javitt, MD, MPH
    Study Chair
    NeuroRx, Inc.
    Locations: United States, Florida
    Miller School of Medicine / University of Miami Medical Center
    Miami, Florida, United States, 33136
    Principal Investigator: Daniel H Kett, MD
    Sub-Investigator: Richard B Silverman, MD
    United States, New York
    Robert I Grossman School of Medicine / NYU Langone Medical Center
    New York, New York, United States, 10016
    Principal Investigator: Daniel H Sterman, MD
    United States, Pennsylvania
    Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania, United States, 19107
    Contact: Ross Summer, MD
    Israel
    Rambam Health Care Campus
    Haifa, Israel, 3109601
    Contact: Yaron Bar-Lavie, MD, FCCP 04-777-2601 y_barlavie@rambam.health.gov.il
    Principal Investigator: Yaron Bar-Lavie, MD, FCCP

    Warom taucht @nummelli immer auf, wenn eine news kommt? Wenn es ins Minus geht, hört man nichts von ihm. Ob er etwas weiss, glaubs eher nicht...Er ist am Spekulieren. Wenn man die letzten drei bis vier Wochen schaut, kommt fast wöchentlich eine Meldung herein. Ich bin mir sicher, dass er gestern billig gekauft, heute puscht er, damit er wieder sei Geld rausnehmen kann.

    Genf (awp) - Das Biotechunternehmen Relief Therapeutics kommt mit seinem Produktkandidaten Aviptadil einen wichtigen Schritt weiter. So wurde der Kandidat nun an der Thomas-Jefferson-Universitätsklinik in Philadelphia zur Behandlung des akuten Atemnotsyndroms (Acute Respiratory Distress Syndrome, ARDS) bei Corona-Patienten in die klinische Erprobung gebracht.




    In die multizentrische Studie sollen Patienten aufgenommen werden, die bereits mechanisch beatmet werden. Man hoffe, die Sterblichkeitsrate bei dieser Erkrankung dank Aviptadil senken zu können, teilte Relief Therapeutics am Donnerstag mit.




    Die Studie ist von der US-Gesundheitsbehörde FDA im Rahmen des Corona Treatment Acceleration Program (CTAP) zur Beschleunigung der Coronabehandlung genehmigt worden.




    hr/uh

    @link


    Jeder will schnel reich werden .


    Zu mindest sind die dran und kommunizieren ob es gut oder schlecht ist.

    Relief Therapeutics (RLF:SIX) drug Aviptadil enters FDA trial at Thomas Jefferson University Hospital in Philadelphia, to treat COVID-19-induced Acute Respiratory Distress


    Aviptadil targets the cytokine storm that causes fatal Respiratory Distress in COVID-19


    Geneva, Switzerland: April 9, 2020

    • Coronavirus (COVID-19) death is primarily caused by Acute Respiratory Distress Syndrome (ARDS), in which severe inflammation causes the lungs to fill with fluid and even mechanical ventilation is unable to maintain life. The syndrome is caused, in part, by a Cytokine Storm unleashed by viral particles.
    • VIP is known to have potent anti-cytokine effects in numerous animal models and in phase 1 and phase 2 human studies

    RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” announces that its drug Aviptadil has now entered FDA clinical trials at Thomas Jefferson University Hospital in Philadelphia for the treatment of Acute Respiratory Distress Syndrome (ARDS) in COVID-19. The multicenter trial will enroll patients who are already on mechanical ventilation in the hopes that Aviptadil can decrease mortality in this condition and help to improve the ability of the patient’s lung to transfer oxygen to the body.


    “We are delighted to be one of the few centers initiating the clinical study of Aviptadil in patients with COVID-19 induced Acute Respiratory Distress (ARDS). This study focuses on patients who are at the heart of our nation’s crisis, namely those receiving mechanical ventilation and that are already receiving maximal conventional therapy. If successful, we hope that treatments such as Aviptadil may change the chances of survival these patients.” said Professor Ross Summer, MD, Section Chief of the Critical Care Division of Thomas Jefferson University Hospital, who is serving as principal investigator for this site.


    The trial is being led by Relief’s US partner, NeuroRx, Inc., whose clinical operations are based in Radnor, PA, 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.


    Death in COVID-19-infected patients is caused in part by a “cytokine storm” in the lungs, in which the virus triggers inflammatory molecules called “cytokines,” which cause the air sacs (alveolae) of the lungs to fill with water and become impermeable to oxygen, even in the setting of mechanical ventilation. VIP is a naturally synthesized peptide which is 40% concentrated in the lungs and which has been shown to have a potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury, and inflammation. It has a 20-year history of safe use in human beings in multiple human trials for sarcoidosis, pulmonary fibrosis, and pulmonary hypertension, and is marketed in Europe as a local injection to treat erectile dysfunction.


    Relief Therapeutics holds FDA and EU orphan drug designations for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a US patent[1] for Aviptadil and proprietary manufacturing processes for its synthesis.


    “In a previous trial of VIP for ARDS in patients with sepsis, 7 of 8 patients on mechanical ventilation showed substantial improvement and 6 ultimately left the hospital alive,” said Prof. Jonathan Javitt, MD, MPH, the CEO of NeuroRx, Inc.. “Patients on ventilators for COVID-19 have only a 50% chance of survival. If the early results can be replicated in ARDS caused by COVID-19, this treatment could have a major impact both on COVID-19 survival and on the availability of ventilators for those in desperate need.”

    Bei 2.7 Rappen habe ein teil verkauft danach bei 2.14 wieder gekauft ;) hoffe kommt was Gutes

    Ich bin weder ein Forscher noch ein Biologe noch ein Wissenschaftler überhaupt. Eines weiss ich sicher, wer zuerst da ist, bekommt den grössten Teil des Kuchens. Da in den USA schon über 300000 sind, werden die Medikamente so schnell wie möglich auf den Markt kommen, ohne gross nach Nebenwirkungen zu forschen. Auch wenn die Wirkung nur bis zu 50 Prozent ist, wird man versuchen die Unruhen damit einzudämmen, bis besseres auf den Markt kommt. Natürlich hoffe ich, dass relief der erste sein wird. Meiner Meinung nach heisst es etwas, wenn Israel da im Spiel ist. Sie haben einen guten Gespür für Geschäfte. Wenn ihr die Todesfälle (aktuel 47) Isreal mit dem Rest der Welt vergleicht, seht ihr einen Unterschied. Wer weiss, vielleicht haben sie schon das Reliefmedikament eingesetzt, da die Todesfälle so niedrig sind. Es ist interessant, wie Isreal von sich alleine auf Relief aufmerksam wurde und sogar die Regierung hat eingewilligt mit Relief zusammenzuarbeiten. Wie viele sagen, war das eine unbekannte Briefkastenfirma in Genf. Wie gesagt, ich bin kein Wissenschaftler usw. Es ist meine Meinung, die ich mit euch teile.


    Bleibt gesund und einen schönen Börsenwochenstart Morgen.

    Ja hat am 01.04.2020 19:19 geschrieben:

    Quote

    Darf ich fragen ob du 2Mio Shares oder CHF meinst?
    Ich bin auch noch mit dabei mit 1.9 Mio Shares

    Ich meine 2 Mio. Stück. Hätte ich 2 Mio. CHF wäre vielleict nicht mehr da... ;)

    JordanBelfort hat am 01.04.2020 18:10 geschrieben:

    Ich habe seit längerem keine so treffende Worte gehört...Respekt. Mit meinen 2,0 Mio. Bin ich immer noch dabei.

    Bei meinem letzten kauf bin über 3000% im plus leider war nur 800fr immer hin bin noch dabei... meine druchschnit EP war ser hoch trotzdem bin zeit gester wieder grün. Ich gönne es allen!

    Die letzte Stunde sind fast 30 Mio. gehamsterr worden. Oder sehe ich nicht richtig?

    FDA grants IND “Study May Proceed” for COVID-19 trial to NeuroRx, Inc. in partnership with RELIEF THERAPEUTICS (SIX:RLF) for treatment of Acute Respiratory Distress


    Aviptadil is a patented form of Vasoactive Intestinal Polypeptide (VIP) that has previously shown promise in treating ARDS


    Geneva, March 29, 2020

    • Coronavirus (COVID-19) death is primarily caused by Acute Respiratory Distress Syndrome (ARDS), in which severe inflammation causes the lungs to fill with fluid and even mechanical ventilation is unable to maintain life. The syndrome is caused by a Cytokine Storm unleashed by viral particles.
    • VIP is known to have potent anti-cytokine effects in numerous animal models and in phase 1 and phase 2 human studies
    • Both FDA and EU have granted orphan drug status to Relief Therapeutics for the development of Aviptadil (VIP) in ARDS

    The US FDA has issued a “Study May Proceed” letter to NeuroRx, a Delaware Corporation within 24 hours of NeuroRx's IND application. In partnership with Relief Therapeutics (SIX:RLF) NeuroRx is now recruiting study sites and pharmacies to commence a phase 2 trial of RLF-100 (Aviptadil) in the treatment of Acute Respiratory Distress in patients infected by the COVID-19 coronavirus. NeuroRx, Inc. is a privately held, drug development company that has previously demonstrated success in developing innovative drugs under FDA Fast Track, Breakthrough Therapy, and Special Protocol Agreement programs. Relief, headquartered in Geneva, Switzerland, previously partnered with Biogen (Nasdaq:BIIB) to develop Aviptadil for the treatment of pulmonary hypertension.


    Acute Respiratory Distress Syndrome (ARDS) in COVID-19-infected patients is caused by a “cytokine storm” in the lungs, in which the virus triggers inflammatory molecules called “cytokines,” which cause the air sacs (alveolae) of the lungs to fill with water and become impermeable to oxygen, even in the setting of mechanical ventilation. Even with access to ventilators and maximal intensive care, half of those with COVID-related ARDS die. In a phase 1 trial of Aviptadil performed by Sami Said, MD, under FDA IND in the early 2000's,[1] 7 of 8 patients treated with intravenous VIP were successfully weaned from mechanical ventilation and six of those patients left the hospital alive. The results demonstrated a meaningful decrease in TNFa (alpha), a known inflammatory cytokine and consistent improvement in oxygenation. VIP is a naturally synthesized peptide which is 40% concentrated in the lungs and which has been shown to have a potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury, and inflammation. VIP has shown the ability to protect the lung even from extreme insults such as hydrochloric acid. It has a 20-year history of safe use in humans in trials of sarcoidosis, pulmonary fibrosis, and pulmonary hypertension, and is marketed in Europe as a local injection to treat erectile dysfunction. At an FDA public hearing in 2016[2], it was noted that more than 8,000 prescriptions for VIP were filled by a compounding pharmacy to treat a chronic inflammatory condition without any reported adverse events.


    Relief Therapeutics holds FDA and EU orphan drug designations for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a US patent[3] for formulation of Aviptadil and proprietary manufacturing processes for its synthesis.


    The trial will be overseen by an independent Data Safety Monitoring Board led by Prof. Alfred Sommer, MD, MHS, Dean Emeritus of the Bloomberg School of Public Health, Prof. Michelle Williams, Dean of the Harvard Chan School of Public Health, and Hon. Andy Harris, M.D., M.H.S. who represents Maryland's first congressional district and is a practicing anesthesiologist.


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



    [1] FDA IND 52,088


    [2] FDA Pharmacy Compounding Advisory Committee, November 3, 2016


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

    nummelin hat am 17.03.2020 11:25 geschrieben:

    Quote

    Bis Freitag 0,05 *yahoo*

    Immer wenn du auf einen bestimmten Betrag tendierst, fällt der Aktienwert vielleicht ist es in Zukunft besser diesbezüglich nichts zu erwähnen. Bei Tageshoch prophezeitest du einen bestimmten Wert und siehe da, der Aktienwert begann zu sinken....