Partner Therapeutics Inc, a biopharmaceutical company, is evaluating Leukine (sargramostim, rhu-GM-CSF) in the SARPAC trial (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19 – EudraCT #2020-001254-22) at University Hospital Ghent, it was reported on Tuesday.
The product will be utilised in nebulised form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulised Leukine has been studied in phase two and phase three randomised 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 two randomised trials in acute respiratory distress syndrome (ARDS).
Major medical centres in Germany, Italy and Spain are planning to join the study. The study will assess the effect of Leukine on lung function and patient results. The use of Leukine to treat respiratory disorders associated with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA