Joint Research on a Regenerative Medicine Product for Chronic Heart Failure
First written in FY2020-Q1. 8 of 12 entries say "Advanced", first in FY2020-Q2. Latest entry: FY2025-H1.
No other company in this theme has enough history to compare yet.
- FY2025-H1DroppedAnnual report
「Following a comprehensive review based on the results of the investigator-initiated Phase IIb trial of the regenerative medical product α-GalCer/DC for chronic heart failure conducted jointly with Kyushu University, the company decided in November 2024 to discontinue development of α-GalCer/DC.」
Based on the results of the investigator-initiated Phase IIb trial of α-GalCer/DC, the company decided to discontinue development in November 2024. - FY2024-Q2AdvancedAnnual report
「For this trial, recruitment ended upon expiry of the scheduled enrollment period at the end of September 2023. The company is currently finalizing the trial data, after which it plans to analyze the data and determine its future development policy for chronic heart failure based on the results (fiscal year ending September 2024).」
The Phase IIb trial of α-GalCer/DC for chronic heart failure ended case-enrollment recruitment and moved to the stage of conducting analysis after finalizing the trial data, then determining the development policy in the fiscal year ending September 2024. - FY2024-Q1Enrollment recruitment ended, moving to analysis and policy decisionsAnnual report
「Because enrollment of the target number of cases was expected to take a considerable period even if the enrollment period were extended, recruitment ended upon expiry of the scheduled enrollment period. After the observation period ends, the company plans to analyze the trial data and determine its future development policy for chronic heart failure based on the results.」
For the Phase IIb trial of α-GalCer/DC for chronic heart failure, recruitment ended following failure to enroll the target number of cases within the deadline and delays in enrollment. The company moved to the stage of determining its development policy based on data analysis after the observation period ends. - FY2023Target case enrollment not achieved by the deadlineAnnual report
「The company aimed to enroll the target number of cases by the end of September 2023 at 5 medical institutions—Kyushu University Hospital, the National Cerebral and Cardiovascular Center Hospital, Juntendo University Hospital, Nara Medical University Hospital, and Kobe City Medical Center General Hospital—but was unable to enroll the target number within the deadline.」
For the investigator-initiated Phase IIb trial of α-GalCer/DC, the company aimed to enroll the target number of cases at 5 medical institutions by the end of September 2023, but enrollment was not completed within the deadline. - FY2023-Q3AdvancedAnnual report
「In addition to Kyushu University Hospital, cases are currently being enrolled at the National Cerebral and Cardiovascular Center Hospital, Juntendo University Hospital, Nara Medical University Hospital, and Kobe City Medical Center General Hospital, with the aim of accelerating progress in the Phase IIb trial and bringing α-GalCer/DC into practical use at an early stage.」
For the Phase IIb trial of α-GalCer/DC for chronic heart failure, cases were enrolled at 4 medical institutions in addition to Kyushu University Hospital, and the company moved to the stage of aiming to accelerate enrollment and achieve early practical application. - FY2023-Q2AdvancedAnnual report
「Case enrollment will also begin at the National Cerebral and Cardiovascular Center Hospital, Juntendo University Hospital, Nara Medical University Hospital, and Kobe City Medical Center General Hospital, with the aim of accelerating enrollment in the Phase IIb trial and bringing α-GalCer/DC into practical use at an early stage.」
For the Phase IIb trial of α-GalCer/DC for chronic heart failure, case enrollment began at 4 medical institutions, and the company moved to the stage of aiming to accelerate enrollment and bring the product into practical use at an early stage. - FY2022-Q3AdvancedAnnual report
「For the next-stage investigator-initiated Phase IIb trial, the company will manufacture the clinical trial product at its Shinagawa CPF. After establishing the manufacturing and supply system, the clinical trial notification was submitted, and the trial is currently under way (trial period, scheduled completion date: 31 March 2024).」
For the regenerative medical product for chronic heart failure, the company moved to the stage of conducting the trial after submitting the clinical trial notification for the Phase IIb trial. The scheduled completion date is 31 March 2024. - FY2022-Q2AdvancedAnnual report
「In addition, the company consulted with PMDA regarding the comparability and consistency of the Phase IIb clinical trial product manufactured at the Shinagawa CPF and the Phase I/IIa clinical trial product already used in the trial. PMDA accepted the submitted comparability and consistency assessment, and the clinical trial notification was submitted during the cumulative second quarter.」
For the regenerative medical product for chronic heart failure, PMDA accepted the comparability and consistency assessment, leading to submission of the clinical trial notification for the Phase IIb trial. - FY2022-Q1AdvancedAnnual report
「The initiative was completed during the cumulative first quarter. In addition, the company consulted with PMDA regarding the comparability and consistency of the Phase IIb clinical trial product manufactured at the Shinagawa CPF and the Phase I/IIa clinical trial product already used in the trial. PMDA accepted the submitted comparability and consistency assessment, and preparations for submitting the clinical trial notification were completed.」
For the regenerative medical product for chronic heart failure, the company established a manufacturing and supply system for the Phase IIb clinical trial product at the Shinagawa CPF, obtained PMDA acceptance of the comparability and consistency assessment, and completed preparations for submitting the clinical trial notification. - FY2021-Q3AdvancedAnnual report
「The Company is currently preparing to commence a physician-initiated Phase IIb clinical trial. Because additional data, including data elucidating the mechanism of action in chronic heart failure, is needed to seek marketing approval for the product, the Company began new joint research with Professor Hiroyuki Tsutsui of Kyushu University in April 2021.」
For the product for chronic heart failure, a new joint research project was launched in April 2021, in addition to preparations for an investigator-initiated Phase IIb clinical trial. - FY2020-Q2AdvancedAnnual report
「Joint research costs for a regenerative medicine product to treat chronic heart failure: ¥230 million, January 2020 to September 2021」
A plan was presented to allocate a total of ¥456 million as the use of proceeds from the 14th and 15th Stock Acquisition Rights for joint research with Kyushu University on a regenerative medicine product for chronic heart failure. - FY2020-Q1First statedAnnual report
「In the same month, we entered into a joint research agreement with Kyushu University to commercialize a regenerative medical product for the treatment of chronic heart failure.」
The Company signed a joint research agreement with Kyushu University to commercialize a regenerative medical product for chronic heart failure.