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CLPT under $10
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Outstanding Shares 16,869,528 11/10/2020
Brain surgery
The Restore-1 trial DSMB did not advise Neurocrine's team to pause or halt the trial back in November, Roberts said. However, it did recommend that the company discontinue its use of the neurosurgical procedure used in the trial at the time, she said. That was presumably a reference to the brain surgery procedure by which NBIb-1817 and another Voyager asset, VY-HTT-01, are designed to be delivered to targeted areas and cells in the brain.
In a previous phase I trial, conducted by the University of California, San Francisco, three patients experienced hemorrhages caused by the surgical procedure for administering VY-AADC, Voyager reported in its most recent quarterly report, on Nov. 9.
In response, in Restore-1, investigators began using Clearpoint Neuro Inc.'s Clearpoint System "to provide accurate placement of the cannula in the putamen and allow for real-time, intra-operative MRI to assist the physician in visualizing the delivery of VY-AADC (NBIb-1817) to the putamen and to avoid specific blood vessels during the duration of the surgical procedure, with the goal of reducing the risk of hemorrhages," Voyager said.
In the same quarterly filing, Voyager said that it might begin using V-TAG, a real-time, intra-operative, MRI-compatible device that it developed with Clearpoint for the procedures.
Even with those changes, the Restore-1 study had been on pause since earlier in the year due to what Roberts called a "major amendment to the study over the course of the summer," one that appears to have included a major streamlining of the trial's primary and secondary outcome measures. Furthermore, screening for the study had been paused as well, particularly in light of the need for trial participants to travel, sometimes across state lines for study-relating brain scans.
Neurocrine's efforts to resolve those issues weren't clear on Wednesday. But Cowen analyst Phil Nadeau remained cautiously optimistic. "The risk to NBIb-1817's further development, as well as the duration of the delay, can't be estimated without understanding the specific issues that the DSMB has identified," he said.
https://www.bioworld.com/articles/501751-fda-puts-parkinsons-trial-on-hold-amid-imaging-abnormalities
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