Anti-interleukin-6 agents are a class of therapeutics. Interleukin 6 is a cytokine relevant to many inflammatory diseases and many cancers. The first approved medication in this class, tocilizumab Actemra , is an antibody directed against the IL6-receptor. Tocilizumab was first used in large-cell lung carcinoma. Such antibodies include tocilizumab and sarilumab.
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Major medical centers in Germany, Italy and Spain are considering joining the study. The study will evaluate the effect of Leukine on lung function and patient outcomes. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. Collectively, the data suggest that aerosolized Leukine may prove to be a meaningful therapy to decrease mortality and increase ventilator-free days in patients with respiratory disorders associated with viruses such as COVID and Influenza A.
For the treatment of COVID associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine has been studied in phase 2 and phase 3 randomized trials in pulmonary conditions that affect alveolar macrophages, such as aPAP. IV administration of Leukine has been studied extensively in other conditions and in phase 2 randomized trials in ARDS.
Leukine was initially approved in the United States in and has been approved for use in five clinical indications. Its safety and tolerability profile are well understood. Strategic National Stockpile. Leukine is distributed outside the U. The use of Leukine to treat respiratory disorders associated with COVID is investigational and has not been fully evaluated by any regulatory authority. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, epithelial repair, and augmentation of innate host defense by effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.
PTx is an U. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required. Twice weekly monitoring of CBC with differential should be performed.
About Partner Therapeutics, Inc. Annual Review of Physiology , Halstead ES, et al. Respir Res. Alveolar epithelial cells orchestrate DC function in murine viral pneumonia. J Clin Invest. Crit Care Med. Immune Modulation in Pediatric Sepsis.
J Pediatr Intensive Care. Inhaled sargramostim and whole lung lavage as therapy of autoimmune pulmonary alveolar proteinosis aPAP. Eur Respir J. Presented at European Respiratory Society meeting DOI: PA Huang F-F, et al. Physical properties, lung deposition modeling, and bioactivity of recombinant GMCSF aerosolized with a highly efficient nebulizer.
Pulm Pharmacol Ther. A randomized phase II trial of granulocyte-macrophage colony-stimulating factor therapy in severe sepsis with respiratory dysfunction. Lung epithelial GM-CSF improves host defense function and epithelial repair in influenza virus pneumonia — a new therapeutic strategy? Mol Cell Pediatr. DOI Protecting against post-influenza bacterial pneumonia by increasing phagocyte recruitment and ROS production. J Infect Dis. N Engl J Med.
Lower respiratory tract delivery, airway clearance, and preclinical efficacy of inhaled GM-CSF in a post-influenza pneumococcal pneumonia model. J Exp Med. Lancet Respir Med. McClements PartnerTX.
Preclinical and preliminary clinical data indicate that ch We conducted a study to determine whether adding ch Patients with high-risk neuroblastoma who had a response to induction therapy and stem-cell transplantation were randomly assigned, in a ratio, to receive standard therapy six cycles of isotretinoin or immunotherapy six cycles of isotretinoin and five concomitant cycles of ch Event-free survival and overall survival were compared between the immunotherapy group and the standard-therapy group, on an intention-to-treat basis. A total of eligible patients were randomly assigned to a treatment group.
Anti-GD2 Antibody with GM-CSF, Interleukin-2, and Isotretinoin for Neuroblastoma