publication date: May. 1, 2020
FDA grants Emergency Use Authorization for novel, non-implanted device to wean patients off mechanical ventilation
FDA has issued Emergency Use Authorization for Lungpacer Medical’s novel Diaphragmatic Pacing Therapy System (DPTS) for immediate use in patients on invasive mechanical ventilators at high risk of weaning failure, including COVID-19 patients.
“Hospital resources around the world have been under significant strain during the COVID-19 pandemic and ICU beds and mechanical ventilators have been at peak demand. This novel therapy has the potential to wean patients earlier from the ventilator and free up resources during these difficult times,” Ali Ataya, assistant professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Florida Health, Gainesville, said in a statement. “We are looking forward as an institution to start using this technology to help our patients during this pandemic.”
Ataya co-authored the publication reporting the results of the RESCUE 1 trial, which demonstrated feasibility, and assessed initial safety and efficacy of the Lungpacer DPTS.
Lungpacer DPTS is the first minimally invasive, temporary, transvenous phrenic-stimulation system cleared through Emergency Use Authorization by the FDA. This non-surgical, non-implanted, diaphragm stimulation therapy is delivered via a central venous catheter, similar to central lines currently placed in mechanically ventilated ICU patients.
The central line is used to deliver both fluids and medications, while also incorporating the capability to activate the diaphragm muscle via transvenous phrenic-nerve stimulation. This stimulation is intended to strengthen a weakened diaphragm, already atrophied by mechanical ventilation and is expected to help patients wean off the ventilator more rapidly.
Reducing time on the ventilator decreases the risk of ventilator-induced lung injury, secondary pneumonias, and poor patient outcomes associated with prolonged mechanical ventilation. Less ventilator time frees up ICU beds, resources and mechanical ventilators, potentially improving ICU throughput and effectively reducing ventilator burden by a projected 26% in patients during this COVID crisis.
TGen seeks volunteers for COVID-19 immunity study
The Translational Genomics Research Institute, an affiliate of City of Hope, is looking for patients recovered from COVID-19 to participate in the COVID Immunity Study.
Participants in The COVID Immunity Study must be U.S. residents, age 18 or older, have tested positive for COVID-19, and then recovered.
This is a research study, and will not be used to diagnose disease among the participants. The study could eventually lead to new methods of diagnosing COVID-19, and help in the development of antibody therapies and vaccines.
“We are using cutting-edge research tools to study, in depth, the immune response to COVID-19,” John Altin, assistant professor in TGen’s Pathogen and Microbiome Division, the institute’s infectious-disease branch in Flagstaff, said in a statement. “Our goal is to enable urgently-needed new diagnostics and treatments for this virus.”
David Engelthaler, director of TGen North and Arizona’s former state epidemiologist, said the study could help better understand how the virus has moved through our community.
“This will help us learn more about how, when and why we produce antibodies in response to a COVID-19 infection. One class of antibodies tackles the infection first, and then another comes in to finish the job,” Engelthaler said in a statement. “Knowing when these different immune responses occur, and how long they last, could help us understand if some patients gain a certain degree of immunity against reinfection. We need to know how that works.”
“To supplement this study, I am leading a research project at City of Hope, in collaboration with Dr. Altin’s lab, that will hopefully result in the development of a COVID-19 virus antibody neutralization test. Together, these two tests will help us understand what is necessary for immune protection against COVID-19,” John Zaia, director of the Center for Gene Therapy at City of Hope, said in a statement.
Those who sign up for TGen’s study will be asked to complete a short online health questionnaire. TGen would then mail them a simple blood-spot collection kit. They would be instructed to prick the end of a finger and put a drop of blood on a sample collection card. A week later, they would put another drop of blood on the sample collection card, and then mail the test back to TGen.
“Our approach will not only tell you which proteins are being targeted, but also be able to tell which regions of each protein are being targeted,” Altin said. “Each protein can be recognized by many different types of antibodies. By looking at this level of detail, we then could see elements of the antibody response that others might be missing.”
J&J and Emergent Bio collaborate on coronavirus vaccine candidate
The Janssen Pharmaceutical Companies of Johnson & Johnson and Emergent BioSolutions Inc. are collaborating to support the manufacturing of Johnson & Johnson’s lead investigational COVID-19 vaccine candidate.
Johnson & Johnson said it hopes to supply more than one billion doses of the vaccine globally.
Under the manufacturing agreement, Johnson & Johnson plans to expand drug substance capacity related to the vaccine candidate. Emergent has agreed to provide drug substance manufacturing services with its molecule-to-market CDMO offering. Emergent may provide operations support for commercial manufacturing of Johnson & Johnson’s COVID-19 vaccine candidate, using Janssen’s AdVac and PER.C6 technologies beginning in 2021.
Johnson & Johnson has begun preparations for clinical vaccine production at its facility in Leiden, the Netherlands, and aims to start phase I human clinical studies of its vaccine candidate in September 2020. Johnson & Johnson will begin production at risk and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.
Johnson & Johnson said it plans to useJanssen’s proven AdVac and PER.C6 technologies to develop new vaccine candidates and upscale production of the optimal vaccine candidate. The same technology was used to develop and manufacture the company’s investigational Ebola vaccine, and construct RSV and HIV vaccine candidates that are now in phase II or phase III of clinical development.