Journal article
Phase I trial of the single-chain urokinase intrapleural LTI-01 in complicated parapneumonic effusions or empyema
L Beckert, B Brockway, G Simpson, AM Southcott, YC Gary Lee, N Rahman, RW Light, S Shoemaker, O Gillies, AA Komissarov, G Florova, T Ochran, W Bradley, H Ndetan, KP Singh, K Sarva, S Idell
Jci Insight | AMER SOC CLINICAL INVESTIGATION INC | Published : 2019
Abstract
BACKGROUND. Current dosing of intrapleural fbrinolytic therapy (IPFT) in adults with complicated parapneumonic effusion (CPE)/empyema is empiric, as dose-escalation trials have not previously been conducted. We hypothesized that LTI-01 (a single-chain urokinase [scuPA]), which is relatively resistant to plasminogen activator inhibitor-1 (PAI-1), would be well tolerated. METHODS. This was an open-label, dose-escalation trial of LTI-01 IPFT at 50,000-800,000 IU daily for up to 3 days in adults with loculated CPE/empyema and failed pleural drainage. The primary objective was to evaluate safety and tolerability, and secondary objectives included assessments of processing and bioactivity of scuPA..
View full abstractGrants
Awarded by National Heart, Lung, and Blood Institute
Funding Acknowledgements
NIH SMARTT HHSN268201100014C (SI) provided funding of the manufacturing of the drug substance, toxicology studies, and regulatory support; NIH UO-1 HL121841-01A1 (SI) provided initial funding in preparation for the clinical trial.