PMDA received an application for a clinical trial for the IND package of GAIA-102 i.v.
On July 9,2021, GAIA BioMedicine applied for a clinical trial with the IND package of GAIA-102 i.v. to the Japanese regulatory authority PMDA (Pharmaceuticals and Medical Device Agency), PMDA noticed their receipt of that to GAIA.
This package contains our Phase I/II clinical trial protocol of GAIA-102 to treat non-small cell lung cancers (NSCLCs), and PMDA started the final 30-days protocol. The Agency schedules to complete the review process on August 7, 2021.
GAIA BioMedicine estimates that the first-patient-in of this epoch-making clinical trial would be in October 2021.