NPXe has announced the enrollment of the first patient in a Phase 3 study of Xenex inhaled xenon gas for the treatment of post cardiac arrest syndrome (PCAS). The FDA granted Fast Track designation to Xenex for this indication earlier this year.
The trial is expected to enroll 1,436 cardiac arrest patients and will compare treatment with Xenex over 24 hours in addition to the current standard of care, which is targeted temperature management (TTM), to TTM alone. The company expects the study to be completed in 2020.
NXPe Chief Operating Officer Matt Napoletano said, “The enrollment of the first patient in this study is an important step in the development of Xenex and builds on our positive Phase 2 clinical trial, which demonstrated a statistically significant reduction in brain tissue damage and a trend towards better survival outcomes in PCAS resulting from an out of hospital cardiac arrest. We believe that if these results are repeated in a larger Phase 3 study in a targeted population of cardiac arrest victims that benefitted most in the Phase 2 trial and Xenex were approved by the FDA and the EMA it would become the de-facto standard of care (in combination with TTM) for PCAS treatment.”
Mallinckrodt has acquired the North American, Japanese, and Australian rights to Xenex, and Linde has acquired the European rights.
Read the NPXe press release.
