Oxycyte: Phase IIb halted
Oxygen halted a double-blind, placebo-controlled, Israeli and Swiss Phase IIb trial of Oxycyte to treat severe non-penetrating TBI due to difficulties in enrollment. The company said it will consider strategic alternatives for the program and review data from patients enrolled in the trial.
The trial was designed to enroll a total of 98 patients in 3 cohorts to receive single 1, 2 and 3 mL/kg IV infusions of Oxycyte. In 2010, an independent DSMB recommended continuation to the second cohort after reviewing safety data from patients who received the 1 mL/kg dose in the first cohort. However, Oxygen stopped enrollment to secure cGMP supply of Oxycyte, reevaluate enrollment parameters and review trial contractors and sites. Enrollment resumed in July 2013. The second cohort planned to enroll 18 patients at the 2 mL/kg dose and cohort 3 planned to initially enroll 18 patients at the 3 mL/kg dose, and then an additional 50 patients at either the 2 or 3 mL/kg dose based on the DSMB's recommendation. ...