30 patients were recruited at six sites in the US and the final patient commenced dosing on 27 February 2020.
The primary purpose of this study was to transition paxalisib from the very late-stage population that was studied in phase I to the newly-diagnosed patients that represent the target population for the commercial product.
Upcoming data to be presented at cancer conference
Kazia has been accepted for a poster presentation at the upcoming American Association for Cancer Research (AACR) annual meeting in San Diego, CA on 24-29 April 2020.
The AACR meeting is one of the world’s largest gatherings of cancer researchers and physicians, and also provides an opportunity for engagement with investors and potential partners.
Kazia anticipates that the AACR poster presentation will provide additional data from the ongoing phase II clinical study, building on the promising signals that were reported in November 2019.
Progressing down registration path
Kazia CEO’s Dr James Garner said: “It has been an exceptionally productive start to 2020 for the paxalisib program, and we are delighted with progress.
“Our ongoing phase II study in glioblastoma has completed recruitment, well ahead of expectations, and we expect to report new interim data in April 2020 at the AACR conference.
“Meanwhile, work is well underway to bring paxalisib into the GBM AGILE study, which is intended to provide a streamlined path to registration for the drug.”
Four additional brain cancer studies underway
In addition to the ongoing phase II study in glioblastoma, four additional studies are
underway in other forms of brain cancer.
All four studies are actively recruiting patients with updates expected through 2020.
GBM AGILE study
In December 2019, paxalisib was selected to join GBM AGILE, an international, academic-led, multi-drug adaptive phase II / III study in glioblastoma.
GBM AGILE is designed to provide an opportunity to test new therapeutic agents in a cutting-edge, registration-level study, at considerably lower cost and in a faster time than would typically be possible for a company-driven study.
This GBM AGILE study is expected to provide the basis for an eventual product registration.
At this stage, Kazia is planning to begin patient enrolment in the second half of calendar 2020.
Proactive caught up with Kazia in November 2019 following the last data release for paxalisib (formerly GDC-0084).