Ivy Brain Tumor Center partners with GSK and UCSF to test Zejula in brain cancer patients

The Ivy Brain Tumor Center (Phoenix) and University of California, San Francisco will partner on a Phase 0 clinical trial to test GSK’s (NYSE:GSK) Zejula (niraparib) in patients with newly diagnosed glioblastoma (GBM) and recurrent glioma (grades II–IV).

Zejula is a daily oral poly (ADP-ribose) polymerase (PARP) inhibitor.

FDA introduced Phase 0 clinical trials in 2004 to close the gap between initial drug testing and later-phase efficacy studies. If a drug shows promise in a Phase 0 trial, investigators can fast-track it to a Phase 2 study.

“Our mission is to do things differently from what has been done before,” said Shwetal Mehta, chief operating officer of the Ivy Brain Tumor Center, in an interview.

Many drugs tested for brain cancer have trouble crossing the blood-brain barrier, and yet conventional trials don’t tend to be nimble enough to measure near-term efficacy.

“We want to identify drugs that are effective, and we want to do thi…

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Ivy Brain Tumor Center sees promise in sonodynamic therapy for glioblastoma

Ivy Brain Tumor Center and its partner Sonalasense have announced positive initial results in a first-in-human Phase 0/1 clinical trial involving recurrent glioblastoma patients.

Sonalasense has developed a noninvasive sonodynamic therapy (SDT) that pairs low-intensity ultrasound with chemotherapeutic agents known as sonosensitizers. The therapy is noninvasive.

Data from the trial indicate that SDT swiftly causes targeted oxidative stress and cell death in human glioblastoma tissue. In addition, the therapy was well tolerated in the study.

Get the full story from our sister site, Drug Discovery & Development. 

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Ivy Brain Tumor Center sees promise in sonodynamic therapy for glioblastoma

Ivy Brain Tumor Center and its partner Sonalasense have announced positive initial results in a first-in-human Phase 0/1 clinical trial involving recurrent glioblastoma patients.

Sonalasense has developed a noninvasive sonodynamic therapy (SDT) that pairs low-intensity ultrasound with chemotherapeutic agents known as sonosensitizers. The therapy is noninvasive.

Data from the trial indicate that SDT swiftly causes targeted oxidative stress and cell death in human glioblastoma tissue. In addition, the therapy was well tolerated in the study.

The Ivy Brain Tumor Center is using MRI-guided focused ultrasound in conjunction with Sonalasense’s 5-aminolevulinic acid (SONALA-001) to investigate the treatment. Investigators administered 5-aminolevulinic acid (ALA) intravenously, which then crosses the blood-brain barrier to enter the brain. Once in the brain, ALA targets glioma cells, which are abnormally metabolically active.

The study used intravenous am…

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