Kazia Therapeutics (ASX:KZA) has announced that its lead program, paxalisib, has been awarded Fast Track Designation by the US FDA.
The designation is for the treatment of solid tumour brain metastases harbouring PI3K pathway mutations in combination with radiation therapy.
The company said the designation is based on promising clinical data from an interim analysis of an ongoing Phase 1 clinical trial in which patients with brain metastases from a primary tumour receive paxalisib in combination with radiotherapy.
Is said the clinical data was presented at the 2022 Annual Conference on CNS Clinical Trials and Brain Metastases, jointly organized by the Society for Neuro-Oncology and the American Society for Clinical Oncology, by Dr Jonathan Yang.
Dr Yang is the lead investigator in the clinical trial.
According to the data, all nine evaluable patients in the trial responded to the combination of paxalisib with radiotherapy.
“Brain metastases are rapidly emerging as a key pillar of paxalisib’s clinical development,” said KAZIA CEO Dr John Friend.
“We have seen a high level of interest from clinicians in the emerging data from this patient population, and it is exciting to now have that interest complemented by FDA’s award of Fast Track Designation. With important data read-outs expected in adult and childhood brain cancer during CY2023, we will be working with investigators and advisors to drive forward our research in brain metastases also.”
The company said further data from the trial is expected in the first quarter of the calendar year 2024.