Argenica submits ethics application to kick off Phase 2 stroke treatment trial
Health & Biotech
Health & Biotech
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Argenica Therapeutics has submitted it ethics application to Melbourne’s St Vincent’s Hospital (SVHM) Human Research Ethics Committee (HREC) to commence its Phase 2 clinical trial to assess the safety and preliminary efficacy of ARG-007 in acute ischaemic stroke (AIS) patients.
The outcome of the decision is expected in mid-September 2023, with approval allowing Argenica (ASX:AGN) to undertake its Phase 2 trial in up to 10 hospitals (trial sites) across Australia.
The ethics submission for Argenica’s Phase 2 trial is through the National Mutual Acceptance program – which means the company is only required to submit its ethics application to one HREC at one hospital to gain approval to conduct its trial across multiple Australian hospitals, thereby speeding up the time to commence the trial.
The Phase 2 trial will assess the safety and preliminary efficacy of ARG-007 in patients who present to emergency departments having suffered an acute ischemic stroke in a large vessel in the brain.
The vials of ARG-007 to be used in the trial are being manufactured and are expected to be received in Dec 2023, allowing for patient recruitment to commence in Q1 CY2024.
The Phase 2 trial will be a Multicentre, 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 (SEANCON).
Only patients with a diagnosed large vessel occlusion (LVO) stroke that are eligible for endovascular thrombectomy (mechanical removal of a clot in the brain) will be eligible to be enrolled in the trial.
LVO strokes account for close to 40% of all acute ischaemic strokes, however, are responsible for 60% of post-stroke dependency and 90% of mortalities after stroke, and therefore are considered the most devastating type of stroke.
Enrolled patients will be randomly assigned to receive either an intravenously (IV) delivered dose of ARG-007 or an IV delivered saline placebo, to be administered prior to completion of endovascular thrombectomy procedure.
Following treatment, patients will be assessed for key safety outcomes as well as infarct volume and functional outcomes via a number of standard assessments.
The trial protocol has already been endorsed by the Australasian Stroke Trials Network (ASTN), the key body in promoting, facilitating, and coordinating stroke trials in Australia. Further, the Australian Stroke Foundation, the national charity supporting the stroke community, is supportive of the trial.
Global experts with extensive experience in running stroke and emergency setting clinical trials have been engaged to assist Argenica in executing the Phase 2 trial, subject to ethics approval.
Prof Graeme Hankey (MBBS, MD, FRACP, FRCP, FAHA, FESO, FWSO, FAHMS) has been appointed as the trial’s National Coordinating Principal Investigator.
Prof Hankey was recently appointed Perron Institute Chair in Stroke Research at The University of Western Australia, with a key focus in developing new therapies and leading clinical trials that evaluate the effectiveness of these therapies in preventing and treating stroke.
The company has also engaged Alithia Life Science, an Australian based life sciences clinical research consultancy, to assist in trial management.
In addition, Argenica has also engaged ProPharma, a global Clinical Research Organisation (CRO) with extensive experience in supporting acute trials in emergency settings.
Propharma will provide critical support services for Argenica’s Phase 2 trial, including trial site management support, data management and clinical data programming, biostatistics, medical monitoring, and pharmacovigilance, all in accordance with regulatory guidelines.
This article was developed in collaboration with Argenica Therapeutics Limited, a Stockhead advertiser at the time of publishing.
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