Phase II Clinical Trial Begun for Xytis
Xytis plans to study the effects of anatibant in phase II clinical trials on 400 patientswith moderate to severe closed head traumatic brain injury in nine countries over the next year. Phase I clinical trials showed favorable clinical safety, tolerability, and pharmokinetic profile. There currently are no drug treatments for the treatment of traumatic brain injury, even though there are about 1.4 million TBI cases a year.
The president and CEO of Xytis said that the phase II trials will take this course of action: "Patients with moderate to severe TBI will receive one of three doses of anatibant or placebo for five days. Endpoints for the trial include safety and tolerability, mortality as well as functional assessment at days six and 15 post-injury."
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