Achieving proof of concept in acute spinal cord injury
First written in FY2020. 11 of 17 entries say "Cited as achieved", first in FY2021-Q1. Latest entry: 2026-07-28.
No other company in this theme has enough history to compare yet.
- FY2024-Q2RestatedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial for acute spinal cord injury continues to be cited as the basis for conducting the Phase III trial. - FY2024-Q1RestatedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial for acute spinal cord injury continues to be cited as the basis for conducting the Phase III trial. - FY2023-Q3RestatedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial for acute spinal cord injury continues to be cited as the basis for conducting the Phase III trial. - FY2023-Q2Cited as achievedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial for acute spinal cord injury continues to be cited as the basis for conducting the Phase III trial. - FY2023-Q1Cited as achievedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the subsequent Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial for acute spinal cord injury was again cited as the basis for the Phase III trial. - FY2022Cited as achievedAnnual report
「We confirmed safety and obtained results suggestive of efficacy. We formulated a plan for the Phase III trial to validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans).」
The company again cites confirmation of safety, results suggestive of efficacy and establishment of proof of concept in the Phase I/II trial for acute spinal cord injury as the basis for the Phase III trial. - FY2022-Q3Cited as achievedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the subsequent Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial for acute spinal cord injury was again cited as the basis for conducting the Phase III trial. - FY2022-Q2Cited as achievedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the subsequent Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial for acute spinal cord injury was again cited as the basis for conducting the Phase III trial. - FY2022-Q1Cited as achievedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the subsequent Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial for acute spinal cord injury was again cited as the basis for conducting the Phase III trial. - FY2021-Q3Cited as achievedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the subsequent Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The company again states that the proof of concept obtained in the Phase I/II trial for acute spinal cord injury supports conducting the Phase III trial. - FY2021-Q2Cited as achievedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the subsequent Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The proof of concept obtained in the Phase I/II trial was again cited as the basis for planning and conducting the Phase III trial. - FY2021-Q1Cited as achievedAnnual report
「To validate the proof of concept obtained in the Phase I/II trial (proof of concept: the usefulness and efficacy of a new drug candidate under development are demonstrated through administration to humans), we formulated a plan for the subsequent Phase III trial and submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) on 9 June 2020.」
The company has again cited the proof of concept obtained in the Phase I/II trial for acute spinal cord injury as the basis for planning and notifying the subsequent Phase III trial. - FY2020First statedAnnual report
「Because a statistically significant difference was observed in the change from baseline at week 20 (day 140) in the ASIA motor score, a secondary endpoint, we believe proof of concept was obtained for HGF’s ability to protect nerve cells and restore motor function.」
The company describes confirming safety and obtaining results suggesting efficacy and proof of concept in a Phase I/II trial for acute spinal cord injury as part of its track record.