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07/11/20

17:22

Post #: 48709683
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Originally posted by Rich&Poor: ↑

Hi Sglatz,
Kazia has stated that the primary focus for FDA registration is to target the paxalisib arm of GBM AGILE with the recruitment of newly diagnosed patients with unmethylated MGMT promotor status, which is the same population that has been investigated in Kazia’s ongoing phase II study.I am not aware of another drug as a competitor for paxalisib as above.

In addition paxalisib will be evaluated at the same time for GBM AGILE to recruit recurrent patients to the paxalisib arm. The drug may ultimately be considered efficacious in either or both of these patient groups, and Kazia will frame any future application for regulatory approval on the basis of this data.
Dr Mellinghoff added, “we see interesting signals of activity in the phase I study of paxalisib in recurrent glioma patients, and so my colleagues and I consider it important to evaluate the drug also in this later-stage group, where the unmet medical need is very substantial. Including both newly diagnosed and recurrent patients in GBM AGILE enables us to observe how paxalisib performs across the spectrum of the disease, and provides us with a significant amount of additional data as we move towards registration.

Upon a successful FDA registration for paxalisib in glioblastoma, the numerous drug combination trials begin.

Regards.

Expand

drug combo trials hopefully by someone else, ie: big pharma who has bought the license for our drug.

imho, trialing on newly diagnosed patients is an incredible feat btw punters. And best of luck to them!

Cheers.

KZA Price at posting: 82.0¢ Sentiment: Buy Disclosure: Held
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