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Find Clinical Drug Pipeline Developments & Deals by Partner Therapeutics
Leukine (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast.
People with Down syndrome are at higher risk for Alzheimer’s, and showed that GM-CSF improves cognition and brain pathology in AD mice and that Leukine® (sargramostim, glycosylated, yeast-derived rhuGM-CSF) improved cognition and reduced blood biomarkers of neuronal damage.
Safety and efficacy of inhaled sargramostim for the treatment of COVID-19 has not been established and sargramostim is not approved for treatment of COVID-19. Sargramostim has a different mechanism of action from recombinant G-CSFs products and data should not be extrapolated.
This study will evaluate the role of Leukine in reducing progression and need for hospitalization in COVID-19 patients. Primary study endpoints are: COVID-19-related emergency room visit, COVID-19- related hospitalization, or death.
SARPAC Clinical Trial of Leukine® met the primary endpoint of improved oxygenation after five days of treatment with inhaled sargramostim in combination with standard of care (SOC) compared with SOC alone.
Data showed that five days of inhaled sargramostim plus standard of care (SOC) treatment improved oxygenation in patients, thereby meeting the primary endpoint.
First patient has been enrolled in the iLeukPulm clinical trial, a randomized phase 2 study of inhaled Leukine in hospitalized COVID-19 patients with acute hypoxemia.
Funding will support two clinical studies of inhaled Leukine® (sargramostim, rhu-Granulocyte Macrophage-Colony Stimulating Factor “GM-CSF”) in patients with COVID-19 associated acute hypoxemia.
The trial will evaluate the effectiveness of Leukine compared to a matched control cohort of G-CSF treated patients, as well as evaluate the immune reconstitution profile of the treated patients compared to a contemporaneous cohort of 20 patients who receive G-CSF.
Company to initiate an investigator-initiated randomized, double-blind, placebo-controlled clinical trial of Leukine(sargramostim, rhu-GM-CSF) in patients with acute respiratory failure associated with COVID-19, conducted at Singapore General Hospital.