Xytis Begins Phase II Clinical Study with Anatibant (XY2405) for Traumatic Brain Injury

Xytis announced it has received approval to initiate 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 this month.

"We are working with the London School of Hygiene and Tropical Medicine (LSHTM), which conducted the largest clinical study in TBI to date. In that trial, over 10,000 patients were enrolled," said Werner Tschollar, MD, Chief Medical Officer of Xytis. "The BRAIN trial will be conducted in 19 centers in 11 countries and is expected to enroll 400 patients by the 1st Quarter of 2008. Patients with moderate to severe TBI will receive one of three doses of Anatibant or placebo for 5 days. Endpoints for the trial include safety and tolerability, mortality as well as functional assessment at days 6 and 15 post-injury."

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

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. "Our decision to undertake this clinical trial was based on several factors," stated Vincent F. Simmon, Ph.D., CEO of Xytis. "There are no drugs that have been shown to be effective in treating TBI to date, the LSHTM is well organized to run such a trial on our behalf, the preclinical efficacy and safety of Anatibant are compelling and a previous small trial of a Bradykinin B2 receptor antagonist peptide (Bradycor) showed promising results. The Bradycor trial was stopped early for reasons unrelated to efficacy, but there were positive trends in mortality and performance. This is suggestive of the potential clinical utility of Xytis' small molecule Bradykinin B2 receptor antagonist Anatibant in effectively treating TBI."