Key Points • Pharmacokinetic (PK) data, which shows how long paxalisib remains in the human body, strongly supports 60mg once daily dosing, confirming planned administration schedule for commercial launch. • Analysis of food effect shows no significant difference between taking paxalisib with food versus on an empty stomach, allowing for a less restrictive administration schedule in commercial use. • Study remains ongoing, with a number of patients still in follow-up. Final data is now expected in 2H CY2021.
Kazia CEO, Dr James Garner, commented, “this is extremely useful and encouraging data, as we begin to compile regulatory documentation for paxalisib and give shape to its potential commercial approval. These results give us great confidence that we are administering the drug at the right dose, at the right frequency, and under the correct conditions. Moreover, the data helps to confirm the approach that we have taken in the GBM AGILE pivotal study.”
KZA Price at posting:
$1.88 Sentiment: Hold Disclosure: Held