Announced details
Malignant pleural mesothelioma, nucleic acid drug delivery, and cancer treatment
No clinically significant adverse reactions were observed, and the drug could be administered safely up to the highest dose. In the repeated-dose study, it could be administered safely up to 3 times.
MIRX002-01 study: 9 participants in total; MIRX002-02 study: 4 participants in total.
We provide the surfactant peptide “A6K,” which PURMX uses to develop MIRX002. We are cooperating with PURMX in the development of this drug.
Head office: Hiroshima City; Representative Director, President and CEO: Tahara Eishun (田原 栄俊). Other details: Not disclosed.
Orphan drug designation in the United States
This matter will have no impact on full-year results or business revenue under the current medium-term management plan. If the status of regulatory approval or other related matters affects results, we will make a timely disclosure.
The company does not address Contract Value / Offering price.
株式会社PURMX Therapeutics, “Primary Endpoint Achieved in the Phase I Trial of ‘MIRX002’ for Malignant Pleural Mesothelioma”
| Item | Details |
|---|---|
| Names of Products / Services Covered | MIRX002, A6K, Drug delivery system (DDS) technology using self-assembling peptides |
| Counterparty | 株式会社PURMX Therapeutics |
| Counterparty overview | Head office: Hiroshima City; Representative Director, President and CEO: Tahara Eishun (田原 栄俊). Other details: Not disclosed. |
| Relationship with the Company | We provide the surfactant peptide “A6K,” which PURMX uses to develop MIRX002. We are cooperating with PURMX in the development of this drug. |
| Applicable area | Malignant pleural mesothelioma, nucleic acid drug delivery, and cancer treatment |
| Award/certification name | Orphan drug designation in the United States |
| Quantitative Effects | No clinically significant adverse reactions were observed, and the drug could be administered safely up to the highest dose. In the repeated-dose study, it could be administered safely up to 3 times. |
| Usage history | MIRX002-01 study: 9 participants in total; MIRX002-02 study: 4 participants in total. |
| Impact on Business Performance | This matter will have no impact on full-year results or business revenue under the current medium-term management plan. If the status of regulatory approval or other related matters affects results, we will make a timely disclosure. |
| Source | 株式会社PURMX Therapeutics, “Primary Endpoint Achieved in the Phase I Trial of ‘MIRX002’ for Malignant Pleural Mesothelioma” |
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.In both the single-dose and repeated-dose studies, no clinically significant adverse reactions were observed, the drug could be administered safely up to the highest dose, and the primary safety and tolerability endpoints were achieved.