Kazia Therapeutics to present pharmacokinetic data from Paxalisib Phase II study at prestigious AACR annual meeting

Kazia Therapeutics Ltd (ASX:KZA) (NASDAQ:KZIA) (FRA:NV9) will share new data from its ongoing phase II study of paxalisib in glioblastoma in a poster presentation at the prestigious American Association of Cancer Research (AACR) Annual Meeting being held virtually from April 10-15 and from May 17-21, 2021.

The new pharmacokinetic (PK) data shows how long paxalisib remains in the human body and strongly supports 60-milligram once-daily dosing, confirming the company’s planned administration schedule for commercial launch. 

In addition, analysis of food effect shows no significant difference between taking paxalisib with food versus on an empty stomach, which would allow for a less restrictive administration schedule in commercial use.

“Key data for potential commercial approval” 

Kazia chief executive officer Dr James Garner said: “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.” 

Final data in H2 2021

The study is ongoing, with several patients still in follow-up and final data expected in the second half of 2021. 

Dr Garner said: “A lot of our efforts at present are focused on assembling the complex package of scientific information that is required to secure FDA approval for any new drug. 

“Today’s data provides one more piece in that jigsaw. 

“More broadly, the phase II study is drawing to a conclusion, and we expect to be able to share final data in the second half of this year.” 

In January 2021, paxalisib opened to recruitment in the GBM AGILE pivotal study, which is expected to provide the basis for registration in the US and other territories. 

Story by ProactiveInvestors