XYTIS TO LAUNCH STUDY OF TREATMENT FOR BRAIN INJURY

Xytis announced it has received approval to begin a Phase II clinical trial with Anatibant for the treatment of traumatic brain injury (TBI) in the United Kingdom and South Africa, and enrollment of the first patient is expected to happen this month.

The BRAIN trial will be conducted in 19 centers in 11 countries and is expected to enroll 400 patients by the first quarter of 2008. 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.

"Previous clinical trials of potential therapeutics in TBI have failed in part because they were vastly underpowered," Werner Tschollar, chief medical officer of Xytis, said. "Xytis' BRAIN trial should be able to detect an improvement of treatment with Anatibant over placebo of as little as 4 percent with a probability of 79 percent."

Anatibant is a selective, very potent, small-molecule Bradykinin B2 receptor antagonist that has been shown to be safe and effective in animal models of TBI. Phase I clinical trials in healthy volunteers and patients with TBI demonstrated a favorable clinical safety, tolerability and pharmokinetic profile.