Abstract WMP1: Results From A Phase 2a Study Of TMS-007, An SMTP Family Anti-inflammatory Prothrombolytic, On Patients With Acute Ischemic Stroke Up To 12 Hours After Onset
In: Stroke ; volume 53, issue Suppl_1 ; ISSN 0039-2499 1524-4628, 2022
academicJournal
Zugriff:
Approved thrombolytic agents are limited in their use for the treatment of acute ischemic stroke (AIS) due to their benefit-risk profile beyond 4.5 h since last known normal (LKN). TMS-007 is a small molecule, SMTP family member with a novel mode of action: promotion of plasminogen-fibrin binding to enhance physiological thrombolysis while inhibiting inflammation at the site of thrombosis. TMS-007 may extend the treatment time window based on nonclinical pharmacological evidence. We evaluated TMS-007 in a randomized, placebo-controlled, double-blind, dose-escalation phase 2a study. TMS-007 or placebo was administered as a single intravenous infusion at a dose of 1, 3, or 6 mg/kg to AIS patients who were ineligible for t-PA or thrombectomy within 12 h of LKN. The number of patients allocated to placebo and TMS-007 at doses 1, 3, and 6 mg/kg were 38, 6, 18, and 28, respectively. The combined TMS-007 dosing group (Group T; n = 52) was compared with placebo group (Group P; n = 38). The average age was ~72 years old and time since LKN to treatment was ~9 h in both groups (not significantly different). The incidence of symptomatic intracranial hemorrhage (ICH) with worsening NIHSS score of <=4 points per site physician (primary endpoint) was 0% in Group T compared to 3% (n = 1) in Group P. The number of ICH event within 24 h, including symptomatic and asymptomatic, was 6 in Group T and 5 in Group P. Total number of AE was 207 in Group T and 162 in Group P, with gastrointestinal diseases as the most common events in both groups (n = 40 and 32, respectively). TMS-007 was associated with a significant improvement in functional independence at 90 days (secondary endpoint): 40% of patients in Group T achieved a score of 0 or 1 on the mRS, compared to 18% in Group P (p < 0.05). Recanalization, defined by any improvement in arterial occlusive lesion score on magnetic resonance angiography in those with visible occlusion at baseline per central neuroradiologist, occurred in 58.3% (14/24) of Group T compared to ...
Titel: |
Abstract WMP1: Results From A Phase 2a Study Of TMS-007, An SMTP Family Anti-inflammatory Prothrombolytic, On Patients With Acute Ischemic Stroke Up To 12 Hours After Onset
|
---|---|
Autor/in / Beteiligte Person: | Nishimura, Naoko ; Niizuma, Kuniyasu ; Wald, Michael ; Hasegawa, Keiko ; Tominaga, Teiji ; Hasumi, Keiji |
Link: | |
Zeitschrift: | Stroke ; volume 53, issue Suppl_1 ; ISSN 0039-2499 1524-4628, 2022 |
Veröffentlichung: | Ovid Technologies (Wolters Kluwer Health), 2022 |
Medientyp: | academicJournal |
DOI: | 10.1161/str.53.suppl_1.wmp1 |
Schlagwort: |
|
Sonstiges: |
|