Biotech company Partner Therapeutics Inc (PTx) said on Tuesday that Leukine will be assessed in the SARPAC trial in patients with acute hypoxic respiratory failure at University Hospital Ghent in Belgium to treat patients with respiratory illness associated with COVID-19.
The company added that major medical centres in Germany, Italy and Spain plan to join the study to evaluate the effect of Leukine (sargramostim, rhu-GM-CSF) on lung function and patient outcomes.
Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. GM-CSF is an immunomodulator that plays a critical role in host defense against pathogens and maintaining immune system.
For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used by the company 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.
In animal studies, GM-CSF reportedly reduced morbidity and mortality due to acute respiratory distress syndrome (ARDS) from viral pneumonia. In clinical studies, Leukine showed beneficial effects in patients with viral pneumonia, according to the company.
Armata Pharmaceuticals announces receipt of FDA Breakthrough Therapy Designation for AP-SA02
GSK reports positive Jideytro data supporting potential first-line lung cancer use
Eloxx Pharmaceuticals commences Phase 2b study of exaluren
Meant Health announces expansion of telehealth access for FDA-approved GLP-1 prescriptions
US FDA grants orphan drug designation for Lundbeck's asedebart
Renova Pharmaceuticals launches first three US generic products
FDA grants Priority Review to Genentech's Enspryng for MOGAD
CordenPharma increases aseptic fill-finish capacity
Biophytis expands BIO101 obesity study to assess weight regain
THX Pharma secures European patent for Batten-1 in juvenile Batten disease
Etcamah–CDK4/6 inhibitor combination approved in US for ESR1-mutated HR-positive breast cancer
Guardant Health wins FDA approval for Guardant360 CDx in advanced breast cancer
Agilent launches S540MD slide scanner system in US
Kali Therapeutics' KT501 Investigational New Drug application cleared by US FDA