ARG-007 / Argenica Therap - LARVOL DELTA

FDA feedback gives Argenica clear path to lift clinical hold on brain drug (The Australian) - "In its full letter, the US Food and Drug Administration (FDA) requested additional information to provide assurance that proposed dosing for a US trial of ARG-007 in acute ischaemic stroke can be achieved safely in humans. The FDA has also requested that Argenica Therapeutics...conduct three additional in vitro cell culture studies with clinical research organisations to address identified gaps in data. AGN plans to use safety data from its Phase 2 acute ischaemic stroke trial, which will be available in September, as part of its response to the FDA’s request for safety assurance."

FDA event • P2 data • Ischemic stroke

A Phase II, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study to Determine the Safety, Preliminary Efficacy, and Pharmacokinetics of ARG-007 in Acute Ischemic Stroke Patients (ANZCTR) - P2 | N=92 | Active, not recruiting | Sponsor: Argenica Therapeutics Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Ischemic stroke

A Phase II, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study to Determine the Safety, Preliminary Efficacy, and Pharmacokinetics of ARG-007 in Acute Ischemic Stroke Patients (ANZCTR) - P2 | N=92 | Recruiting | Sponsor: Argenica Therapeutics Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2024

Enrollment open • Trial initiation date • Cardiovascular • Ischemic stroke

A Phase II, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study to Determine the Safety, Preliminary Efficacy, and Pharmacokinetics of ARG-007 in Acute Ischemic Stroke Patients (ANZCTR) - P2 | N=92 | Not yet recruiting | Sponsor: Argenica Therapeutics Ltd

New P2 trial • Cardiovascular • Ischemic stroke

A study to investigate ARG-007 in Healthy Volunteers (ANZCTR) - P1 | N=32 | Completed | Sponsor: Argenica Therapeutics Ltd. | Initiation date: Sep 2000 ➔ Sep 2022

Trial initiation date • Cardiovascular • CXCL8 • IFNG • IL10 • IL4 • IL6 • TNFA