Imaging Biometrics, a wholly-owned subsidiary of IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF), been has granted orphan drug designation (ODD) status for its oral gallium maltolate (GaM) for the treatment of pediatric glioblastoma multiforme (GBM), an aggressive form of brain tumour.
ODD status is granted to medications or therapies intended to treat rare diseases or conditions. Benefits include tax advantages, grant funding and potential market exclusivity.
In February, Imaging Biometrics was granted ODD status for adult GBM patients.
The US Food and Drug Administration (FDA) has since confirmed that the designation granted in February applies to all GBM patients.
GBM is the most common and aggressive primary brain tumour in adults and children. There are currently no effective treatments for pediatric glioblastoma.
Oral GaM recently demonstrated significant survival benefits in a pre-clinical study for pediatric GBM, making it an attractive potential treatment option for both pediatric and adult patients.
"We are very pleased that the FDA has now confirmed that the orphan drug designation for GaM applies to all GBM populations including pediatric patients," said Trevor Brown, chief executive of IQ-AI.