inhalable liposomal hydroxychloroquine (ISPM19) / Taiwan Liposome Company - LARVOL DELTA

"1/2 Hb 6.7 g/dl TLC 1920 N50L47M2 Platelets 40,000 MCV 112 RDW 18 P/S No blasts seen Stress cytogenetic test - increased chromosome breakages on exposure to mytomycin C" (@Satyayadav__)

The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Taiwan Liposome Company; Recruiting ➔ Completed; Trial completion date: Dec 2021 ➔ Jun 2021; Trial primary completion date: Dec 2021 ➔ Jun 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Taiwan Liposome Company; Active, not recruiting ➔ Recruiting; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Apr 2021 ➔ Dec 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Taiwan Liposome Company

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

TLC Provides Corporate Update at Investor Conference (GlobeNewswire) - "Following peer review and confirmation that the literature proficiently answers fundamental questions asked by Clinical and Translational Science Journal and verifying that a novel inhalable liposomal hydroxychloroquine formulation could serve as a promising targeted delivery strategy to treat COVID-19 disease by providing antiviral effect at a significantly lower and safer dose, the first manuscript of TLC19 (inhalable liposomal hydroxychloroquine) has officially been published in the publication of American Society of Clinical Pharmacology and Therapeutics (ASCPT). The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021."

P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease

A Strategy to Treat COVID-19 Disease with Targeted Delivery of Inhalable Liposomal Hydroxychloroquine: A Pre-clinical Pharmacokinetic Study. (PubMed, Clin Transl Sci) - "Similar results were observed relative to IT administration of unformulated HCQ. These pharmacokinetics results in an animal model demonstrated the proof of concept that inhalable liposomal HCQ may provide clinical benefit and serve as a potential treatment for COVID-19."

Journal • PK/PD data • Infectious Disease • Novel Coronavirus Disease

TLC Enrolls First Subject in Phase I Clinical Trial of Inhalable Anti-COVID-19 Program (TLC19) (GlobeNewswire) - "TLC...today announced that the first subject has been enrolled in the Phase I clinical trial of TLC19....The Phase I randomized, vehicle-controlled, blinded study will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of inhaled TLC19 in 30 healthy volunteer subjects....Inhaled version of the off-patent malaria drug HCQ, physiologically based pharmacokinetic modeling from the Phase I pharmacokinetic results could be leveraged to rapidly enable dosing in subsequent trials of patients with COVID-19..."

Enrollment status • Infectious Disease • Novel Coronavirus Disease

TLC Receives Australian and Taiwan Approval to Initiate Phase I Clinical Trial of TLC19 Inhalable Liposomal Hydroxychloroquine for COVID-19 (GlobeNewswire) - "TLC...today announced the receipt of ethical and scientific approval from the Bellberry Human Research Ethics Committee (HREC) in Australia for the Company’s Phase I clinical trial of TLC19....The approval comes following the acceptance of TLC’s investigational new drug (IND) application with the Taiwan Food and Drug Administration (TFDA)....The Phase I randomized, vehicle-controlled, blinded study will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of inhaled TLC19 in 30 healthy volunteers."

IND • New P1 trial • Infectious Disease • Novel Coronavirus Disease

"$TLC Submits IND Application for TLC19 Inhalable Liposomal #Hydroxychloroquine for #COVID19" (@BioStocks)

Infectious Disease • Novel Coronavirus Disease

TLC Submits Investigational New Drug (IND) Application for TLC19 Inhalable Liposomal Hydroxychloroquine for COVID-19 (GlobeNewswire) - "TLC...today announced the submission of an Investigational New Drug (IND) Application to the Taiwan Food and Drug Administration (TFDA) for TLC19 Hydroxychloroquine Liposome Inhalation Suspension for the treatment of coronavirus disease 2019 (COVID-19)."

IND • Infectious Disease • Novel Coronavirus Disease