IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF) said the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) status for gallium maltolate (GaM) to treat glioblastoma multiforme (GBM) brain cancer.
GaM is the oral agent under study in IQ-AI's sponsored Phase I clinical trial underway at the Medical College of Wisconsin (MCW).
Enrolment is ongoing in the trial to evaluate the safety and tolerability of GaM and to identify the recommended dose, necessary for a Phase II clinical trial.
A Phase II clinical trial, the next major developmental step, will be undertaken to assess if GaM works in GBM, IQ-AI added.
Orphan drug status is given for new treatments of serious and life-threatening conditions that affect fewer than 200,000 people in the US.
While outside the drug approval process, it offers benefits such as tax credits, grant opportunities, and seven years of market exclusivity post-approval.
In a statement, Trevor Brown, IQ-AI’S chief executive, said: "This designation is a critical milestone in the development of GaM. It brings the possibility of making an oral agent available as a treatment option for glioblastoma multiforme brain cancer, closer to reality."