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ARTICLE | Clinical News

Bone stops Phase III of Preob cells in osteonecrosis for futility

November 9, 2018 6:26 PM UTC

Bone Therapeutics S.A. (Euronext:BOTHE) discontinued a Phase III trial of its Preob cells to treat osteonecrosis of the hip after an interim 12-month analysis by a DSMB showed that the trial was unlikely to meet its primary endpoint at the final 24-month analysis.

The interim analysis included 44 patients with early stage non-traumatic osteonecrosis of the hip. The double-blind, European trial was slated to enroll 118 patients and evaluated the proportion of patients with clinically relevant pain relief and no progression to fracture stage compared with placebo at 24 months as its primary endpoint. Preob comprises human autologous bone-forming cells derived from bone marrow stem cells...

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