2023-11-01 08:53:03 ET
Kazia Therapeutics ( NASDAQ: KZIA ) on Wednesday provided a preliminary update from an ongoing study of its paxalisib lead program.
Licensed from Genentech in late 2016, paxalisib is an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer.
An investigator-initiated Phase 2 clinical trial is ongoing to assess paxalisib as monotherapy treatment in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL). To date, fourteen (14) patients have been enrolled in the study who will be administered paxalisib as monotherapy for up to 24 months, in an initial dosing regimen of 60mg daily.
Although early clinical activity was observed in some patients, several heavily pretreated r/r PCNSL patients experienced treatment-related adverse events consistent with those previously reported with paxalisib, that resulted in dose reductions and, in some cases, early termination from the study.
As such, the investigator has optimized the study protocol to initiate starting doses at 15mg twice a day or 30mg once a day.
"We are encouraged by the clinical activity preliminarily observed to date and agree with the lead investigator to reduce the dose with the goal of improving tolerability and durability of response," stated Dr. John Friend, CEO Kazia Therapeutics.
Shares of the oncology-focused drug development company gained ~11% premarket on Wednesday
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Kazia issues update on paxalisib study in CNS lymphoma patients