Announced details
Acute spinal cord injury; acute cervical spinal cord injury
25 patients in the previous Phase III trial; track record from the Phase I/II trial (details: Not disclosed)
The company has discussed and reached agreement with PMDA on the design, sample size, primary endpoints, and other aspects of the additional Phase III trial.
An agency responsible for reviewing applications for the approval of pharmaceuticals and other products. The document does not state its location, representative, capital, or year of establishment.
3 clinical trial sites (location: Not disclosed)
The company believes that clarifying the policy for the additional domestic trial following discussions with PMDA will help reduce uncertainty in its development plan in Japan. It considers this highly significant for future business development, including partnering activities with overseas companies, but has not disclosed the monetary impact on financial results.
The company does not address Contract Value / Offering price.
Patient enrollment track record and number of target patients in clinical trials conducted to date in patients with cervical spinal cord injury, data from past clinical trials, data on natural recovery, and the results of various simulations
| Item | Details |
|---|---|
| Names of Products / Services Covered | HGF (hepatocyte growth factor) |
| Counterparty | PMDA (the Pharmaceuticals and Medical Devices Agency) |
| Counterparty overview | An agency responsible for reviewing applications for the approval of pharmaceuticals and other products. The document does not state its location, representative, capital, or year of establishment. |
| Relationship with the Company | The company has discussed and reached agreement with PMDA on the design, sample size, primary endpoints, and other aspects of the additional Phase III trial. |
| Launch date | The patient enrollment period is scheduled to run from July 2026 to June 2028. The timing of enrollment of the first patient has not been specified. |
| Applicable area | Acute spinal cord injury; acute cervical spinal cord injury |
| Location | 3 clinical trial sites (location: Not disclosed) |
| Location scale | 3 clinical trial sites; 10 patients planned for the additional trial |
| Usage history | 25 patients in the previous Phase III trial; track record from the Phase I/II trial (details: Not disclosed) |
| Impact on Business Performance | The company believes that clarifying the policy for the additional domestic trial following discussions with PMDA will help reduce uncertainty in its development plan in Japan. It considers this highly significant for future business development, including partnering activities with overseas companies, but has not disclosed the monetary impact on financial results. |
| Source | Patient enrollment track record and number of target patients in clinical trials conducted to date in patients with cervical spinal cord injury, data from past clinical trials, data on natural recovery, and the results of various simulations |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To respond to questions from individual investors and ensure fair disclosure of information. The company has chosen not to disclose individual analysis results or detailed statistical design due to their potential impact on future development strategy, competitive considerations, and the interpretation of trial results.