Kazia Therapeutics Limited (NASDAQ: KZIA) said GBM AGILE, a pivotal study for paxalisib in newly diagnosed glioblastoma, did not meet pre-defined criteria for continuing to a second stage.
Patients enrolled in the first stage of the paxalisib arm will continue on treatment as per protocol, and in follow-up, until completion of the final analysis, which Kazia anticipates receiving in 2H of 2023.
Given that recruitment is complete, the study will not open to the paxalisib arm in Germany or China.
Kazia will work with its licensing partner to determine the way forward in China.
All Kazia personnel remain blinded to efficacy and safety data from the ongoing study.
Kazia CEO, James Garner, commented, "Today's news defines the remaining trajectory of the study, with modestly positive implications for both costs and timelines, and with some specific consequences for regulatory strategy in China. It does not allow us to draw any meaningful inferences about the outcomes of the study, and indeed it is critical for regulatory purposes that we remain blinded to the evolving data."
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