Phase IIb Clinical Trial of SB623 for Chronic-Phase Cerebral Infarction
First written in FY2017-Q1. 23 of 36 entries say "Restated". Latest entry: 2026-09-17.
0 other companies' latest entry also says "Advanced".
- 2026-09-17AdvancedFinancial results presentation
「来期、PMDAと試験デザイン合意予定。臨床試験開始に向けて準備中」
慢性期脳梗塞について、PMDAとの協議予定の再確認から、来期の試験デザイン合意予定と臨床試験開始準備という具体的な工程の提示へ進んだ。 - FY2027-H1RestatedAnnual report
「In Japan, we also plan to hold discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) regarding ischemic stroke and are advancing preparations to begin clinical trials.」
The policy of holding discussions with the PMDA and advancing preparations to begin the clinical trial for SB623 chronic-phase cerebral infarction has been reconfirmed. - FY2026RestatedAnnual report
「In Japan, during the current fiscal year, we aim to begin discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) in preparation for clinical trials for the SB623 chronic-phase ischemic stroke program.」
The policy of aiming to begin discussions with the PMDA toward a clinical trial in Japan for chronic-phase cerebral infarction has been reconfirmed. - FY2026-H1RestatedAnnual report
「The Company also plans to consult with regulatory authorities in Japan and the United States toward conducting a new clinical trial for chronic stroke.」
With respect to chronic-phase cerebral infarction, the policy of holding discussions with the US and Japanese regulatory authorities toward a new clinical trial has been reconfirmed. - FY2025RestatedAnnual report
「The Company also plans to consult with regulatory authorities in Japan and the United States toward conducting a new clinical trial for chronic stroke.」
With respect to chronic-phase cerebral infarction, the policy of continuing discussions with the US and Japanese regulatory authorities toward a new clinical trial based on the additional analysis results has been reconfirmed. - FY2025-H1ReframedAnnual report
「With the United States, the largest market, as its central focus, the Company plans to consult with regulatory authorities in Japan and the United States toward conducting new clinical trials, including for chronic stroke, based on Acugo®'s track record in Japan.」
The chronic stroke programme was reoriented from preparations for a domestic clinical trial to a focus on new global clinical trials centred on the United States and consultations with regulators in Japan and the United States, based on the domestic approval track record. - FY2024-Q3RestatedAnnual report
「For the SB623 chronic stroke programme, the Company will advance efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects, promptly after obtaining approval for the domestic SB623 chronic traumatic brain injury programme.」
The policy of proceeding with preparations to launch a domestic clinical trial for chronic stroke based on the additional analysis of the US Phase IIb trial after obtaining approval for the domestic chronic traumatic brain injury programme has been reaffirmed. - FY2024-Q2RestatedAnnual report
「For the SB623 chronic stroke programme, the Company will advance efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects, promptly after obtaining approval for the domestic SB623 chronic traumatic brain injury programme.」
The policy of proceeding with preparations to launch a domestic clinical trial for chronic stroke based on the additional analysis of the US Phase IIb trial after obtaining approval for the domestic chronic traumatic brain injury programme has been reaffirmed. - FY2024-Q1SoftenedAnnual report
「For the SB623 chronic stroke programme, the Company will advance efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects, promptly after obtaining approval for the domestic SB623 chronic traumatic brain injury programme.」
Efforts to launch a domestic clinical trial for chronic stroke are continuing, but the implementation sequence has been specified: they will proceed after approval is obtained for the domestic SB623 chronic traumatic brain injury programme. - FY2023RestatedAnnual report
「The Company will advance efforts toward launching the next clinical trial, including considering its design based on the results of this additional analysis.」
The policy of considering the design of and preparing to launch the next clinical trial for chronic stroke based on the additional analysis results from the US Phase IIb trial has been reaffirmed. - FY2023-Q3RestatedAnnual report
「For the SB623 chronic stroke programme, the Company is advancing efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects.」
The policy of advancing efforts to launch a domestic clinical trial for SB623 chronic stroke based on the additional analysis results from the US Phase IIb trial has been reaffirmed. - FY2023-Q2RestatedAnnual report
「For the SB623 chronic stroke programme, the Company is advancing efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects.」
The policy of advancing efforts to launch a domestic clinical trial for SB623 chronic stroke based on the additional analysis results from the US Phase IIb trial has been reaffirmed. - FY2023-Q1RestatedAnnual report
「For the SB623 chronic stroke programme, the Company is advancing efforts to launch a clinical trial in Japan based on the additional analysis results from the US Phase IIb clinical trial, which failed to meet its primary endpoint and involved 163 subjects.」
The policy of advancing efforts to launch a domestic clinical trial for SB623 chronic stroke based on the additional analysis of the US Phase IIb trial has been reaffirmed. - FY2022-Q2RestatedAnnual report
「However, in September 2020, an additional analysis of the STR-02 trial evaluated efficacy 6 months after administration of SB623 using a composite FMMS endpoint in 77 patients with infarct lesion sizes below a specified threshold, representing 47% of all patients enrolled in the trial. Improvement was observed in 49% of the 51 patients in the SB623 group, compared with 19% of the 26 patients in the sham-surgery group, producing a statistically significant result (P-value=0.02).」
The additional analysis results from the STR-02 chronic stroke trial and the policy of prioritising preparations for domestic development of stroke and intracerebral haemorrhage have been reaffirmed. - FY2021-Q3RestatedAnnual report
「However, in September 2020, an additional analysis of the STR-02 trial evaluated efficacy 6 months after administration of SB623 using a composite FMMS endpoint in 77 patients with infarct lesion sizes below a specified threshold, representing 47% of all patients enrolled in the trial. Improvement was observed in 49% of the 51 patients in the SB623 group, compared with 19% of the 26 patients in the sham-surgery group, producing a statistically significant result (P-value=0.02).」
The additional analysis of the STR-02 chronic stroke trial reaffirmed results among 77 patients showing improvement in 49% of the SB623 group versus 19% of the sham-surgery group, with a P-value of 0.02. - FY2021-Q2AdvancedAnnual report
「However, as the Group continued to conduct detailed additional analyses, in September 2020 it evaluated efficacy 6 months after administration of SB623 using a composite FMMS endpoint in an additional analysis of the STR-02 trial involving 77 patients with infarct lesion sizes below a specified threshold, representing 47% of all patients enrolled in the trial. Improvement was observed in 49% of the 51 patients in the SB623 group, compared with 19% of the 26 patients in the sham-surgery group, producing a statistically significant result (P-value=0.02). In response, the Group began preparations to launch late-stage clinical trials for the next SB623 stroke programme and the intracerebral haemorrhage programme.」
For the STR-02 trial after failure to meet the primary endpoint, an additional analysis of 77 patients with infarct lesion sizes below a specified threshold found improvement in 49% of the SB623 group versus 19% of the sham-surgery group, with a P-value of 0.02. Based on these results, preparations proceeded for the launch of late-stage clinical trials for stroke and intracerebral haemorrhage. - FY2021-Q1RestatedAnnual report
「Next, for the SB623 chronic stroke programme, the Group has decided to continue development with the aim of global expansion, and will determine the design of the next clinical trial and consider conducting it in the fiscal year ending January 2021 and thereafter.」
The policy of considering the design and implementation of the next clinical trial toward global expansion has been reaffirmed despite the failure to meet the primary endpoint. - FY2020RestatedAnnual report
「The Group has decided to continue development with the aim of global expansion, and will determine the design of the next clinical trial and consider conducting it in the fiscal year ending January 2021 and thereafter.」
The policy of continuing development, including considering the design and implementation of the next clinical trial, has been reaffirmed despite the failure of the Phase IIb trial for chronic stroke to meet its primary endpoint and the termination of the co-development agreement. - FY2020-Q3ReframedAnnual report
「After reviewing its overall business-strategy priorities based on a detailed analysis of the Phase IIb clinical trial for this product, Sumitomo Dainippon Pharma Co., Ltd. decided to discontinue co-development. Meanwhile, the Group will continue developing the product for chronic stroke with the aim of global expansion.」
The plan was revised so that Sumitomo Dainippon Pharma would discontinue co-development while the Group continued developing SB623 for chronic stroke. - FY2020-Q1ReframedAnnual report
「Meanwhile, the Phase IIb clinical trial for the SB623 chronic stroke programme being conducted jointly with Sumitomo Dainippon Pharma Co., Ltd. in the United States, involving 163 subjects, produced analysis results in January 2019 showing that it failed to meet the primary endpoint. However, the Company decided to continue development with the aim of global expansion. It will conduct a detailed analysis, determine the design of the next clinical trial based on the results, and consider conducting the trial in the following fiscal year and thereafter.」
Following failure to meet the primary endpoint, the plan was revised to continue development toward global expansion and to consider the design and implementation of the next clinical trial based on a detailed analysis. - FY2019Failure to meet the primary endpointAnnual report
「Meanwhile, the Phase IIb clinical trial for the SB623 chronic stroke programme being conducted jointly with Sumitomo Dainippon Pharma Co., Ltd. in the United States, involving 163 subjects, produced analysis results in January 2019 showing that it failed to meet the primary endpoint.」
The analysis results from the US Phase IIb trial for chronic stroke involving 163 subjects, released in January 2019, showed that the primary endpoint was not met. Detailed results were still under analysis, and the Company stated that it would formulate its future development and business plans. - FY2019-Q3RestatedAnnual report
「The Phase IIb clinical trial for the SB623 chronic stroke programme being conducted jointly with Sumitomo Dainippon Pharma Co., Ltd. in the United States completed enrolment of all 163 subjects in December 2017 and is currently in a 12-month follow-up period. The results are scheduled to be announced in the first half of the fiscal year ending January 2020 (February–July 2019).」
The status of the US Phase IIb trial for chronic stroke has been reaffirmed: enrolment of 163 subjects was completed, the trial is in a 12-month follow-up period, and results are scheduled for announcement in the first half of the fiscal year ending January 2020. - FY2019-Q2RestatedAnnual report
「The chronic stroke programme is conducting a Phase IIb clinical trial jointly with Sumitomo Dainippon Pharma Co., Ltd. in the United States. Enrolment of all 163 subjects was completed in December 2017, and the trial is currently in a 12-month follow-up period. The results are scheduled to be announced in the first half of the fiscal year ending January 2020 (February–July 2019).」
The existing progress of the US Phase IIb trial for chronic stroke has been reaffirmed: enrolment of 163 subjects was completed, the trial is in a 12-month follow-up period, and results are scheduled for announcement in the first half of the fiscal year ending January 2020. - FY2018AdvancedAnnual report
「In the United States, the Phase IIb clinical trial for SB623 in chronic stroke began in December 2015 under a co-development arrangement with licensee Sumitomo Dainippon Pharma Co., Ltd. The trial involved 156 subjects and used a double-blind design. The final subject was enrolled in December 2017, and enrolment was ultimately completed with 163 subjects. The trial is currently in a 12-month follow-up period, and the results are scheduled to be announced in the first half of the fiscal year ending January 2020.」
In the US Phase IIb trial for chronic stroke, enrolment was completed with 163 subjects, exceeding the planned 156, and the trial proceeded to a 12-month follow-up period, with results scheduled for announcement in the first half of the fiscal year ending January 2020. - FY2018-Q3AdvancedAnnual report
「During the third quarter of the current cumulative consolidated period, enrolment progressed smoothly in the US Phase IIb clinical trial for the SB623 chronic stroke programme, involving 156 subjects and using a double-blind design, with more than 85% of the planned 156 subjects enrolled as of the filing date. The trial also passed the external data and safety monitoring committee's review for continuation when 75% of the patients had been enrolled, and enrolment is continuing with the goal of completing it by the end of March 2018.」
Enrolment in the US Phase IIb trial involving 156 subjects exceeded 85%, and the trial passed the external data and safety monitoring committee's continuation review at the 75% enrolment point. The goal of completing enrolment by the end of March 2018 was also stated. - FY2018-Q2RestatedAnnual report
「During the second quarter of the current cumulative consolidated period, enrolment proceeded sequentially in the US Phase IIb clinical trial for the SB623 chronic stroke programme, involving 156 subjects and using a double-blind design, after enrolment of the first subject began in March 2016.」
The existing plan to continue sequential enrolment in the US Phase IIb trial for SB623 chronic stroke, involving 156 subjects, has been reaffirmed. - FY2018-Q1RestatedAnnual report
「During the first quarter of the current cumulative consolidated period, enrolment proceeded sequentially in the US Phase IIb clinical trial for the SB623 chronic stroke programme, involving 156 subjects and using a double-blind design, after enrolment of the first subject began in March 2016.」
The existing plan to continue sequential enrolment in the US Phase IIb trial for SB623 chronic stroke, involving 156 subjects, has been reaffirmed. - FY2017RestatedAnnual report
「In the United States, the first subject was enrolled in March 2016 in the Phase IIb clinical trial for the SB623 chronic stroke programme, involving 156 subjects and using a double-blind design, and subject enrolment has since proceeded sequentially.」
Sequential enrolment is continuing in the US Phase IIb trial involving 156 subjects, reaffirming the current status. - FY2017-Q3RestatedAnnual report
「In the United States, the first subject was enrolled in March 2016 in the Phase IIb clinical trial for the SB623 chronic stroke programme, which was planned to involve 156 subjects. Subsequently, in July 2016, the first subject was enrolled in the Phase II clinical trial for the SB623 chronic traumatic brain injury programme, which was planned to involve 52 subjects. Subject enrolment is currently proceeding sequentially in the 2 development programmes in the United States.」
The existing plan to continue enrolment in the Phase IIb clinical trial for SB623 chronic stroke, involving 156 subjects, has been reaffirmed. - FY2017-Q2RestatedAnnual report
「First, in the United States, the first subject was enrolled in March 2016 in the Phase IIb clinical trial for the SB623 chronic stroke programme, which was planned to involve 156 subjects. Subsequently, in July 2016, the first subject was enrolled in the Phase II clinical trial for the SB623 chronic traumatic brain injury programme, which was planned to involve 52 subjects. Subject enrolment is currently proceeding sequentially in the 2 development programmes in the United States.」
Enrolment is continuing in the Phase IIb chronic stroke trial, which is planned to involve 156 subjects, reaffirming the existing development plan. - FY2017-Q1First statedAnnual report
「In the Phase IIb clinical trial of the cell therapy SB623 for chronic stroke being conducted in the United States, involving 156 subjects, enrolment of the first 2 subjects began, and subject enrolment is currently proceeding sequentially.」
For the US Phase IIb trial involving 156 subjects, enrolment of the first 2 subjects began and sequential enrolment is continuing.