Benzinga - by Vandana Singh, Benzinga Editor.
Wednesday morning, Kazia Therapeutics Limited (NASDAQ:KZIA) announced the early conclusion based on safety and clinical response findings observed to date of an important two-part Phase 1 trial.
During market trading, Kazia Therapeutics shares are trading lower after initially spiking higher amid increased volatility in the stock.
Soon after the trial update, the stock reached as high as $0.73 during the premarket session.
Kazia Therapeutics stock is trading on a strong volume of 19.17 million compared to an average volume of 230.237K as per data from Benzinga Pro.
The investigator-initiated trial evaluated the use of paxalisib (an oral PI3K/mTOR dual inhibitor) with radiation therapy to treat patients with PI3K pathway mutation brain metastases from solid tumors.
Part 1 of the study established the maximal tolerated dose (MTD) of paxalisib in combination with radiation therapy, while also demonstrating signs of clinical activity in all nine evaluable patients.
Part 2 was a follow-on expansion cohort to further evaluate the safety and efficacy of the MTD (45mg daily) combined with radiation therapy in up to 12 additional patients.
After reviewing the Part 2 patient data generated to date, the three lead investigators have determined that the study’s primary endpoint has been reached.
In addition, the investigators continued to observe signs of clinical response in patients in the expansion cohort.
Detailed findings from Part 2 of this study are slated for submission and presentation at a forthcoming global scientific meeting.
Last year, paxalisib was awarded Fast Track Designation based on Part 1 data by the FDA for solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy.
Approximately 200,000 cancer patients develop brain metastases in the U.S. each year.
Price Action: KZIA shares are down 24.2% at $0.30 on the last check Wednesday.
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