Kazia Therapeutics stock (NASDAQ: KZIA) skyrocketed during intraday trading on Wednesday following the announcement of phase II/III clinical trial results for Paxalisib in treating Glioblastoma.
Kazia Therapeutics, an Australian oncology-focused drug development company, has reported encouraging outcomes from its phase II/III clinical trial, GBM AGILE, evaluating the efficacy of paxalisib in treating glioblastoma, a severe brain cancer. This study found that newly diagnosed patients with a specific unmethylated genetic marker experienced meaningful improvements in overall survival rates.
GBM AGILE Study Results
The Global Coalition for Adaptive Research sponsored the trial. It compared paxalisib with the current standard of care for glioblastoma patients. The findings revealed that newly diagnosed patients with unmethylated MGMT promoter status treated with paxalisib had a median overall survival of 15.54 months, compared to 11.89 months for those receiving the standard treatment.
Dr. John Friend, CEO of Kazia Therapeutics, expressed optimism about the findings, emphasizing a 3.8-month improvement in survival, representing an approximate 33% increase compared to the concurrent standard of care arm. The company plans to propose accelerated FDA approval for paxalisib, citing promising results.
The GBM AGILE study enrolled 313 patients between January 2021 and May 2022, with control group data collected from July 2019 to May 2022. The primary analysis indicated a median overall survival of 14.77 months for paxalisib-treated patients versus 13.84 months for those on the cumulative standard of care. However, a prespecified secondary analysis revealed an even more substantial survival benefit.
In addition, Kazia reported that paxalisib was well-tolerated with no new safety concerns identified, but did not detect an efficacy signal in patients with recurrent disease, prompting further analysis.
These results are consistent with earlier phase II data and support the potential of paxalisib as a glioblastoma treatment. The drug has already received orphan drugs and fast-track designations from the FDA for this indication.
The company plans to present complete data from the paxalisib arm of the GBM AGILE study at a scientific meeting later this year.
Kazia Therapeutics Stock (NASDAQ: KZIA) Reaction
KZIA stock soared 248.02% on Wednesday, closing at $0.6682, marking a 211.81% increase for the week. The trading volume was 450,243,168 shares, significantly higher than the average daily volume of 7.46 million.
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