Policy & Regulation
Partner Therapeutics to evaluate Leukine in SARPAC trial to treat patients with respiratory illness associated with COVID-19
25 March 2020 -

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.

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