$RLFTF RLF-100. Details. In late March Prep
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Posted On: 08/10/2020 1:23:53 AM
$RLFTF RLF-100. Details.
In late March
Preparing for a phase II trial of intravenous Aviptadil for COVID-19-associated acute respiratory distress; filed an IND with the FDA.
April 9, it entered FDA clinical trials at Thomas Jefferson University Hospital in Philadelphia to treat acute respiratory distress syndrome in COVID-19; the trial will enroll patients who are already on mechanical ventilation;
May 11, Neurorx filed investigational protocol with FDA under the Coronavirus Treatment Acceleration Program for a phase II/III study assessing inhaled drug in patients with non-acute lung injury due to COVID-19;
May 14, final manufacturing completed for phase IIb/III trial to assess intravenous formulation in individuals on mechanical ventilation; enrollment initiated at first U.S. site;
June 2, treated first of 120 patients in phase IIb/III study; primary endpoints are mortality and index of respiratory distress;
June 8, expanded a phase II study to include patients receiving high flow oxygen and noninvasive ventilation, in addition to those on ventilators;
June 11, added Houston Methodist Hospital as a research site;
June 24, FDA granted fast track designation for treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19;
July 16, data monitoring committee reviewed findings from the first 30 patients, concluding that the study should continue;
July 29, FDA granted expanded access protocol to those ineligible for enrollment in clinical trial, including pregnant women, who exhausted approved therapies;
Aug. 3, Neurorx and Relief said RLF-100 allowed rapid recovery from respiratory failure in the most critically ill COVID-19 patients; independent researchers reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes; RLF-100 was granted fast track designation by the FDA and is being developed as a material threat medical countermeasure with the U.S. NIH and other federal agencies; RLF-100 is a patented formulation of vasoactive intestinal polypeptide;
Aug. 6, FDA approved the IND for the phase II/III study
Details From Bioworld.com. (Therapeutics In Development)
In late March
Preparing for a phase II trial of intravenous Aviptadil for COVID-19-associated acute respiratory distress; filed an IND with the FDA.
April 9, it entered FDA clinical trials at Thomas Jefferson University Hospital in Philadelphia to treat acute respiratory distress syndrome in COVID-19; the trial will enroll patients who are already on mechanical ventilation;
May 11, Neurorx filed investigational protocol with FDA under the Coronavirus Treatment Acceleration Program for a phase II/III study assessing inhaled drug in patients with non-acute lung injury due to COVID-19;
May 14, final manufacturing completed for phase IIb/III trial to assess intravenous formulation in individuals on mechanical ventilation; enrollment initiated at first U.S. site;
June 2, treated first of 120 patients in phase IIb/III study; primary endpoints are mortality and index of respiratory distress;
June 8, expanded a phase II study to include patients receiving high flow oxygen and noninvasive ventilation, in addition to those on ventilators;
June 11, added Houston Methodist Hospital as a research site;
June 24, FDA granted fast track designation for treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19;
July 16, data monitoring committee reviewed findings from the first 30 patients, concluding that the study should continue;
July 29, FDA granted expanded access protocol to those ineligible for enrollment in clinical trial, including pregnant women, who exhausted approved therapies;
Aug. 3, Neurorx and Relief said RLF-100 allowed rapid recovery from respiratory failure in the most critically ill COVID-19 patients; independent researchers reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes; RLF-100 was granted fast track designation by the FDA and is being developed as a material threat medical countermeasure with the U.S. NIH and other federal agencies; RLF-100 is a patented formulation of vasoactive intestinal polypeptide;
Aug. 6, FDA approved the IND for the phase II/III study
Details From Bioworld.com. (Therapeutics In Development)
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