Announced details
Treatment of locally advanced non-small cell lung cancer
The primary endpoint is the 1-year progression-free survival rate. Specific efficacy figures are Not disclosed.
The company’s PAI-1 inhibitor RS5614 will be used in an investigator-initiated clinical trial for which Hiroshima University is the coordinating research institution.
Hiroshima University is the coordinating research institution. The trial will be conducted at 12 medical institutions in Japan.
12 medical institutions in Japan, 27 cases
Selection for AMED funding will reduce the company’s expenditures on this trial. These expenses and related costs are scheduled to be reflected in the full-year earnings forecast for the fiscal year ending March 2027 and disclosed accordingly.
The company does not address Contract Value / Offering price.
Results of the earlier Phase II trial disclosed on 5 March 2026, and AMED’s FY2026 Clinical Research and Clinical Trial Promotion Research Program
| Item | Details |
|---|---|
| Names of Products / Services Covered | PAI-1 inhibitor RS5614 |
| Counterparty | Hiroshima University Hospital, Okayama University Hospital, Shimane University Hospital, Hiroshima City Hiroshima Citizens Hospital, Tottori University Hospital, Kagawa University Hospital, Kochi University Hospital, National Hospital Organization Iwakuni Medical Center, Ehime University Hospital, Nara Medical University Hospital, Tohoku University Hospital, Hiroshima Prefectural Hospital |
| Counterparty overview | Hiroshima University is the coordinating research institution. The trial will be conducted at 12 medical institutions in Japan. |
| Relationship with the Company | The company’s PAI-1 inhibitor RS5614 will be used in an investigator-initiated clinical trial for which Hiroshima University is the coordinating research institution. |
| Launch date | The clinical trial began in April 2026; patient dosing is scheduled to begin sequentially going forward. |
| Applicable area | Treatment of locally advanced non-small cell lung cancer |
| Location scale | 12 medical institutions in Japan, 27 cases |
| Quantitative Effects | The primary endpoint is the 1-year progression-free survival rate. Specific efficacy figures are Not disclosed. |
| Impact on Business Performance | Selection for AMED funding will reduce the company’s expenditures on this trial. These expenses and related costs are scheduled to be reflected in the full-year earnings forecast for the fiscal year ending March 2027 and disclosed accordingly. |
| Source | Results of the earlier Phase II trial disclosed on 5 March 2026, and AMED’s FY2026 Clinical Research and Clinical Trial Promotion Research Program |
Items this document does not state (8)
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.An earlier Phase II trial confirmed that combining RS5614 enhanced the antitumor effects of immune checkpoint inhibitors, and higher efficacy was confirmed at an earlier stage of treatment. The company also explained that RS5614 may suppress pulmonary injury associated with radiation therapy and durvalumab.