Argenica Therapeutics (ASX: AGN) has confirmed the first acute ischaemic stroke (AIS) patient has been dosed in its Phase 2 clinical trial of ARG-007.
Argenica is a biotechnology company developing novel therapeutics to reduce brain tissue death after stroke and other neurological conditions.
The patient presented to the Royal Melbourne Hospital emergency department with a suspected AIS. Following confirmation of a large vessel occlusion (LVO) suitable for a mechanical thrombectomy procedure and meeting other eligibility criteria for inclusion in the Phase 2 trial, the patient was dosed with an intravenous infusion. Given this is a blinded clinical trial, none of the trial staff, nor Argenica staff, know whether the patient received ARG-007 or the placebo.
Three of the 10 hospitals participating in the trial are now activated and ready to dose patients, being Royal Melbourne Hospital, Princess Alexandra Hospital, and John Hunter Hospital. Another three hospitals will be activated in the coming weeks, being Liverpool Hospital, Royal Adelaide Hospital, and Royal Brisbane Women’s and Children’s Hospital. The remaining four hospitals will be activated over the next three months following governance approval.
Following dosing of the first five patients, a review of patient safety will be conducted by the clinical trial Data Safety Monitoring Board (DSMB). Additional patient safety reviews will be conducted by the DSMB following dosing of 23 patients, 46 patients, 69 patients, and at the completion of dosing of 92 patients.
“We are absolutely delighted to have officially commenced our Phase 2 clinical trial by dosing our first stroke patient,” Dr Liz Dallimore, Managing Director of Argenica, said.
“We will be carefully monitoring the recruitment of patients in this trial, and report progress as we go. We have engaged an amazing clinical trial team in hospital stroke units across Australia and are looking forward to continuing to work with them throughout the trial.”
Trial overview
The Phase 2 trial is a multicentre, double-blinded, randomised, placebo-controlled, parallel-group, single-sose study to determine the safety, preliminary efficacy, and pharmacokinetics of ARG-007 in Acute Ischemic Stroke Patients (SEANCON).
The trial is designed to test how safe ARG-007 is in acute ischaemic stroke (AIS) patients, with safety being a significant regulatory hurdle in neurology drug development. Proving ARG-007 is safe in AIS patients will pave the way for Argenica to progress to a pivotal Phase 3 trial and further engage with global pharmaceutical companies.