Plus Therapeutics (PSTV) said Wednesday that the US Food and Drug Administration has cleared its investigational new drug application for Reyobiq, paving the way for a phase 1/2a trial targeting pediatric patients with recurrent or progressive high-grade glioma and ependymoma.
The company said the trial, which will assess safety, maximum tolerated dose, and preliminary efficacy in patients aged 6 to 21, will be funded by a $3 million grant from the US Department of Defense.
The phase 1 portion will enroll 24 patients using a dose-escalation approach, while phase 2 will evaluate efficacy in an additional 32 patients, it said.
Shares of the company were rising more than 103% in recent premarket activity.
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