Announced details
Treatment of patients with acute spinal cord injury
The number of spinal cord injury patients in Japan is estimated at approximately 6,000 per year, with the total number of patients, including those in the chronic phase, estimated at 100,000–200,000.
Recipient of the clinical trial notification. No capital, personnel or business relationship is stated.
An independent administrative agency responsible for the review of pharmaceuticals, medical devices and other products, as well as safety measures. The document does not state its official address, representative, capital or year of establishment.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Miyakoshi N et al. Spinal Cord 2021 Jun;59(6):626-634.
Shingu Hikosuke (新宮彦助), “Prevention of Spinal Cord Injury,” Journal of the Japanese Paraplegia Medical Society 13:48-49, 2000
Sakai Hiroaki (坂井宏旭), “Epidemiological Survey,” Comprehensive Rehabilitation 36:969-972, 2008
| Item | Details |
|---|---|
| Names of Products / Services Covered | Oremepermin alfa (International Nonproprietary Name; development code: KP-100IT), HGF (hepatocyte growth factor) |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Counterparty overview | An independent administrative agency responsible for the review of pharmaceuticals, medical devices and other products, as well as safety measures. The document does not state its official address, representative, capital or year of establishment. |
| Relationship with the Company | Recipient of the clinical trial notification. No capital, personnel or business relationship is stated. |
| Launch date | The additional Phase III clinical trial is scheduled to begin, but the specific start date is Not disclosed. The company plans to announce the trial outline after the final review of the clinical trial notification has been completed. |
| Applicable area | Treatment of patients with acute spinal cord injury |
| Usage history | The number of spinal cord injury patients in Japan is estimated at approximately 6,000 per year, with the total number of patients, including those in the chronic phase, estimated at 100,000–200,000. |
| Source | Miyakoshi N et al. Spinal Cord 2021 Jun;59(6):626-634., Shingu Hikosuke (新宮彦助), “Prevention of Spinal Cord Injury,” Journal of the Japanese Paraplegia Medical Society 13:48-49, 2000, Sakai Hiroaki (坂井宏旭), “Epidemiological Survey,” Comprehensive Rehabilitation 36:969-972, 2008 |
Items this document does not state (10)
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.Based on the analysis results of the completed Phase I/II and Phase III trials, the study will use a new criterion to select cases with more severe injury and a trial design intended to improve the response rate.