Drugmaker halts study after 2 unrelated deaths

Vertex Pharmaceuticals paused a Type 1 diabetes drug trial after two patients died. The drugmaker said the deaths are unrelated to the therapy and that it is waiting on independent review before restarting the study. 

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The trial is a phase 1/2 study for Vertex’s VX-880, an insulin-producing therapy being tested among diabetes patients with hypoglycemia, according to a Jan. 7 news release. Seventeen participants were enrolled in the study, according to clinicaltrials.gov, but one patient withdrew consent from the study, the release said.

All 14 patients who received VX-880 “demonstrated islet cell engraftment and production of endogenous insulin,” Vertex said. 

“Two patient deaths, both unrelated to VX-880, have occurred,” the drugmaker said. “Vertex has placed the study on a protocol-specified pause, pending review of the totality of the data by the independent data monitoring committee and global regulators.”

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