A single intravenous dose of ARG-007 was safe and well tolerated in acute ischaemic stroke patients undergoing thrombectomy, with no significant difference in treatment-emergent adverse events (RR 1.02; 95% CI 0.91-1.15; P=0.72).
RCT (n=93)
double-blind
1:1
Sí
Does a single intravenous dose of ARG-007 improve safety and reduce infarct volume in acute ischemic stroke patients undergoing endovascular thrombectomy?
In patients with acute ischemic stroke undergoing endovascular thrombectomy, a single intravenous dose of ARG-007 was safe and well tolerated but did not significantly reduce infarct volume at 48 hours.
Estimación del efecto: RR 1.02 (95% CI 0.91-1.15)
valor p: p=0.72
Abstract Background and aims The Phase II SEANCON study aimed to evaluate the safety, tolerability, and preliminary efficacy of a single intravenous dose of ARG-007 (a cationic poly-arginine peptide with cerebroprotective effects in preclinical models) in patients with AIS undergoing revascularisation by endovascular thrombectomy. Methods SEANCON was a multicentre, randomized, double-blind, placebo-controlled trial conducted at 10 Australian stroke centres. Large vessel occlusion AIS patients, eligible for endovascular thrombectomy within 24 hours of symptom onset, were enrolled and randomized 1:1 to ARG-007 or placebo. Enrolment criteria included baseline NIHSS 5 and prestroke mRS 0–3, site-assessed ASPECTS 0–5 were excluded. All participants received standard-of-care thrombectomy with/without intravenous thrombolysis. The primary outcomes were measures of safety. The secondary outcome was infarct volume at 48 hours. Results 93 participants were randomized (ARG-007 n = 46; placebo n = 47). Follow-up to day 90 was completed by 77 (83%) participants; 16 (17%) participants died before day 90. There was no significant difference between treatment groups in treatment-emergent adverse events (risk ratio RR:1.02, 95% CI: 0.91-1.15; P = 0.72), mortality at day 90 (RR:1.70, 0.67-4.30, P = 0.26), symptomatic intracranial hemorrhage (RR:4.09, 0.47-35.2, P = 0.20), worsening of the index stroke (RR:2.04, 0.76-5.52, P = 0.16), or functional independence at day 90 (mRS 0-2: odds ratio 0.92, 0.36-2.37, P = 0.86). Infarct volume at 48 hours did not differ significantly between groups (ratio (adjusted): 1.65, 0.97–2.81, P = 0.065). A potential subgroup signal favoring ARG-007 was observed in participants with poor collateral circulation. Conclusions In AIS patients, ARG-007 was safe and well tolerated. Conflict of interest David Blacker: Shareholder in Argenica Therapeutics Ltd and is paid a consultancy fee as Chair of the Argenica Clinical Advisory Committee. All other authors have nothing to disclose.
Hankey et al. (Fri,) conducted a rct in Acute ischaemic stroke with large vessel occlusion (n=93). ARG-007 vs. placebo was evaluated on treatment-emergent adverse events (measures of safety) (RR 1.02, 95% CI 0.91-1.15, p=0.72). A single intravenous dose of ARG-007 was safe and well tolerated in acute ischaemic stroke patients undergoing thrombectomy, with no significant difference in treatment-emergent adverse events (RR 1.02; 95% CI 0.91-1.15; P=0.72).