Data Shows Direct Link Between COVID-19 and Acute Respiratory Distress Syndrome (ARDS) In Infected Patients

PALM BEACH, Fla., July 22, 2020 /PRNewswire/ -- There is a direct link between the COVID-19 virus and acute respiratory distress syndrome (ARDS) in COVID-19 patients. According to the National Institutes of Health about 80% of COVID-19 infections are mild or asymptomatic and never require hospitalization but about 5% of patients become critically ill and develop acute respiratory distress syndrome. An article from Johns Hopkins Medical adds that COVID-19, can cause lung complications such as pneumonia and, in the most severe cases, acute respiratory distress syndrome… As COVID-19 pneumonia progresses, more of the air sacs become filled with fluid leaking from the tiny blood vessels in the lungs. Eventually, shortness of breath sets in, and can lead to acute respiratory distress syndrome, a form of lung failure. COVID-19 patients with ARDS are often unable to breath on their own and may require ventilator support to help circulate oxygen in the body. Active healthcare stocks in news today include:  Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), Moderna, Inc., (NASDAQ: MRNA), Oragenics, Inc. (NYSE: OGEN), Pfizer Inc. (NYSE: PFE), Dynavax Technologies Corporation (NASDAQ: DVAX).

Another report from ReportsAndData addresses the result of this association on ARDS revenues. They said: "The global acute respiratory distress syndrome (ARDS) market… is expected to reach USD 934.8 Million by the year 2026, at a CAGR of 6.0%. Acute respiratory distress syndrome (ARDS) is a respiratory disease wherein the lungs cannot adequately deliver oxygen to the vital body organs. In Acute respiratory distress syndrome (ARDS), fluid gets accumulated in tiny elastic air sacs called alveoli and creates blockade for the lungs to breathe air… oxygen is not adequately delivered to the body organs, which can affect their proper functioning. Rising R&D activities by local companies and education institutes to develop advanced and effective treatment methods for ARDS can augment regional market growth."

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) BREAKING NEWS - Citius Pharmaceuticals Forms Scientific Advisory Board for the Planned Development of its Proprietary Treatment for Acute Respiratory Disease Associated with COVID-19  - Citius Pharmaceuticals ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today the formation of the Citius ARDS (Acute Respiratory Distress Syndrome) Scientific Advisory Board to provide the company expert guidance on  its planned development of induced mesenchymal stem cells (iMSCs) under option from Novellus, Inc. to treat and reduce the severity of acute respiratory distress syndrome (ARDS) associated with COVID -19.

The ARDS Advisory Board consultants are:

Michael A. Matthay, MD, Professor of Medicine and Anesthesia at the University of California at San Francisco (UCSF), a Senior Associate at the Cardiovascular Research Institute, and Associate Director of the Critical Care Medicine at UCSF. Dr. Matthay's basic research has focused on the pathogenesis and resolution of the acute respiratory distress syndrome (ARDS), with an emphasis on translational work and patient-based research, including clinical trials. Dr. Matthay's recent research has focused on the biology and potential clinical use of allogeneic bone marrow derived mesenchymal stromal cells (MSCs) for ARDS. He is currently leading the "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)," a United States Department of Defense supported study of MSCs for ARDS.

Mitchell M. Levy, MD, Chief, Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, The Warren Alpert Medical School of Brown University, where he is Professor of Medicine. Dr. Levy also serves as Medical Director of the Medical ICU at Rhode Island Hospital. He has been an investigator on numerous pharmacologic and biologic trials intended to treat sepsis, cardiovascular and pulmonary pathology. He has expertise in trial design, clinical trial execution and trial management and is one of the three founding members of the Surviving Sepsis Campaign (SSC). Dr. Levy is Past-President of the Society of Critical Care Medicine (2009).

Lorraine B. Ware, MD, Professor of Medicine and Ralph and Lulu Owen Endowed Chair, Professor of Pathology, Microbiology and Immunology, Vanderbilt University; Director, Vanderbilt Medical Scholars Program.  Dr. Lorraine Ware's comprehensive bench-to-bedside research program centers on the pathogenesis and treatment of sepsis and acute lung injury with a current focus on mechanisms of lung epithelial and endothelial oxidative injury by cell-free hemoglobin.  Dr. Ware is also a lead investigator for the "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)" study.

"We are extremely pleased to have been able to attract such a prestigious group of experts to advise and guide us in the Company's planned development of iMSC's for the treatment of ARDS" said Mr. Myron Holubiak, CEO of Citius.  "These individuals are recognized opinion leaders and expert in the planning and execution of clinical trials in this therapeutic area. We will be seeking their advice in all phases of our clinical trial design."  Read this full release at:  https://ir.citiuspharma.com/press-releases/detail/109/citius-pharmaceuticals-forms-scientific-advisory-board-for

In other healthcare news of note:

Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and the Icahn School of Medicine at Mount Sinai ("Mount Sinai") announced they have entered into a collaboration to develop a universal influenza (flu) vaccine. Mount Sinai's current work in this area is funded under a contract award from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), as part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program established by NIAID. The Mount Sinai CIVICs team will evaluate a novel approach they have developed called chimeric hemagglutinin (cHA) designed to protect against all strains of influenza in combination with Dynavax's CpG 1018TM adjuvant.

The development program will support an Investigational New Drug (IND) application for Phase I clinical trials. Drs. Peter Palese, PhD, Professor and Chair of the Department of Microbiology at Mount Sinai, Adolfo-Garcia-Sastre, PhD, Director of the Global Health and Emerging Pathogens Institute, and the Irene and Dr. Arthur M. Fishberg Professor of Microbiology and Medicine (Infectious Diseases) at Mount Sinai, and Florian Krammer, PhD, Professor of Microbiology at Mount Sinai will be leading the development of the program.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government's Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA).

Oragenics, Inc. (NYSE American: OGEN) announced that the National Institutes of Health (the "NIH") created stabilized pre-fusion spike protein (CoV-2 S-2P) licensed by the Company has generated neutralizing antibodies in mice during immunization against SARS-CoV-2, the virus that causes COVID-19.

The NIH's preclinical study shows that this spike protein, adjuvanted with the TLR-4-agonist Sigma Adjuvant System (a TLR-4 agonists that induces T cell activation), generates neutralizing antibody titers in both a pseudovirus neutralization assay and a plaque reduction neutralization titer (PRNT) assay. In addition, this immunization produced a balanced Th1/Th2 response. The results are reported in Corbett et al. BioRxiv. 2020

Moderna, Inc., (NASDAQ: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, recently announced the publication of an interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The New England Journal of Medicine. This interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart across three dose levels (25, 100, 250 µg) in 45 healthy adult participants ages 18-55 years, and reports results through Day 57. Results from participants in the initial dose cohorts who received both vaccinations and were evaluated at pre-specified timepoints reaffirm the positive interim data assessment announced on May 18th and show mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2. The study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

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