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ACTISAVE (Paper Poster Area) - Apr 19, 2023 - Abstract #ESOC2023ESOC_1252;
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Journal: Targeting platelet GPVI with glenzocimab: a novel mechanism for inhibition. (Pubmed Central) - Apr 4, 2023 Glenzocimab did not bind to a truncated GPVI missing loop residues 129-136, thus validating the epitope identified in the crystal structure. Overall, these findings demonstrate that the binding of glenzocimab to the D2 domain of GPVI induces steric hindrance and structural modifications that drive the inhibition of GPVI interactions with its major ligands.
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Review, Journal: Glenzocimab: A GPVI (Glycoprotein VI)-Targeted Potential Antiplatelet Agent for the Treatment of Acute Ischemic Stroke. (Pubmed Central) - Oct 27, 2022 Although glenzocimab 1000 mg (a selected dose) did not demonstrate a significant improvement in overall clinical outcomes, it appeared to provide benefits in severe cases and in patients who required thrombectomy. This promising efficacy together with a good safety profile of glenzocimab warrant further investigation in phase III (ACTISAVE [Adaptive Efficacy and Safety Study of Glenzocimab Used as an Add-On Therapy on Top of Standard of Care in the 4.5 Hours Following an Acute Ischemic Stroke]) clinical study.
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GLENZOCIMAB, A NOVEL ANTITHROMBOTIC, SHOWS FAVORABLE SAFETY PROFILE IN A SYSTEMATIC REVIEW OF DATA WITHIN THE CLINICAL DEVELOPMENT PROGRAM (Room 332) - Oct 1, 2022 - Abstract #WSC2022WSC_536; P1/2, P2, This promising efficacy together with a good safety profile of glenzocimab warrant further investigation in phase III (ACTISAVE [Adaptive Efficacy and Safety Study of Glenzocimab Used as an Add-On Therapy on Top of Standard of Care in the 4.5 Hours Following an Acute Ischemic Stroke]) clinical study. This favorable safety profile within three clinical studies allowed glenzocimab, a novel antithrombotic, to enter a larger ongoing phase II/III study, ACTISAVE (NCT05070260).
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Targeting platelet Glycoprotein VI with Glenzocimab: a novel mechanism of inhibition (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_806; Rearrangements within this domain prevent D2 homotypic interactions and formation of GPVI dimers of high affinity for collagen and fibrin. Glenzocimab induces allosteric modifications within the D1 domain with alterations of the betaC and betaF strands in the CRP binding groove.
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Glenzocimab does not impact bleeding severity in two different mouse models of intracranial hemorrhage (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_444; Conversely, GPIIbIIIa deficiency and eptifibatide treatment caused a significant increase in intracranial bleeding in both models and were associated with increased mortality in the model of hyperglycemia-induced hemorrhagic transformation of cerebral ischemia-reperfusion injury. Conclusion(s): In contrast to eptifibatide, glenzocimab does not increase bleeding severity in case of intracranial hemorrhage.
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Trial completion, Trial primary completion date: ACTIMIS: Acute Ischemic Stroke Interventional Study (clinicaltrials.gov) - Oct 6, 2021 P1/2, N=160, Completed, The 1000mg dose was selected for Phase 2. Recruiting --> Completed | Trial primary completion date: Jun 2021 --> Sep 2021
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Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: ACTIMIS: Acute Ischemic Stroke Interventional Study (clinicaltrials.gov) - Nov 27, 2020 P1/2, N=160, Recruiting, Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2021 --> Jul 2021 Not yet recruiting --> Recruiting | N=100 --> 160 | Trial completion date: Jan 2020 --> Sep 2021 | Trial primary completion date: Dec 2019 --> Jun 2021
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Journal: Pharmacological Blockade of GPVI Promotes Thrombus Disaggregation in the Absence of Thrombin. (Pubmed Central) - Oct 8, 2020 Not yet recruiting --> Recruiting | N=100 --> 160 | Trial completion date: Jan 2020 --> Sep 2021 | Trial primary completion date: Dec 2019 --> Jun 2021 This work identifies an unrecognized role for GPVI in maintaining thrombus stability and suggests that targeting GPVI could dissolve platelet aggregates with a poor fibrin content.
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Clinical, PK/PD data, Journal: Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT017, an Antiplatelet GPVI (Glycoprotein VI) Fab. (Pubmed Central) - Jan 31, 2020 In contrast, administration of ACT017 inhibited collagen-induced platelet aggregation measured by light transmission aggregometry on platelet-rich plasma, and the extent and duration of the effect were dose-dependent. Conclusions- The novel antiplatelet agent ACT017 has consistent pharmacokinetic/pharmacodynamic properties and favorable safety and tolerability profiles warranting further clinical development.
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