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Biopharmaceuticals Neurology

 News Release - March 13, 2007

Xytis Enrolls First Patient in Phase II Clinical Study With Anatibant (XY2405) for Traumatic Brain Injury

'Brain Trial' (Bradykinin B2 Receptor-Antagonist-'Anatibant' in Neurotrauma)

IRVINE, Calif. and NYON, Switzerland, March 13 (HSMN NewsFeed) -- Xytis announced it has enrolled the first patient in the Company's Phase II clinical trial with Anatibant for the treatment of traumatic brain injury (TBI).

"We plan to enroll 400 patients with moderate to severe closed head TBI in 9 countries over the next 12 months," said Vincent F. Simmon, Ph.D., President and CEO of Xytis. "We are working with the London School of Hygiene and Tropical Medicine (LSHTM), which has considerable and unique experience in enrolling patients with TBI in highly-recruiting centers throughout the world. 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."

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 with anatibant in healthy volunteers and patients with TBI demonstrated a favorable clinical safety, tolerability and pharmokinetic profile. "A previous study gave strong support validating Bradykinin B2 as the appropriate target for reducing the secondary damage that occurs due to inflammation and increased permeability of the blood brain barrier, leading to increased intracranial pressure. Anatibant is one thousand times more potent than Bradycor, the compound used in that previous study, and has a much better pharmacodynamic profile," said Rowland Furcha, project manager for Xytis.

"Our decision to undertake this clinical trial was based on several factors," stated Simmon. "There are no therapeutics for TBI despite the fact that the CDC estimates that in the US there are 1.4 million TBI cases per year of which 50,000 patients die and 235,000 are hospitalized with moderate to severe TBI. Among survivors, 5.2 million people require assistance in performing daily activities, resulting in costs of $60 billion. Worldwide the incidence is estimated to be 10 million cases per year with 1 million of these occurring in the US, Europe and Japan. Therefore a successful drug in TBI will be extremely valuable for patients and its developer."

About Xytis:

Xytis Inc. is a privately held international discovery and development biopharmaceutical company focusing on innovative CNS drug candidates. The company has received funding from Atlas Venture, Sanderling Ventures, CDC Entreprises Innovation, and Ventech. Xytis has a rich portfolio of proprietary preclinical compounds that are novel, highly selective allosteric modulators of nicotinic Acetylcholine Receptors (nAChRs), GABA-A receptors and other well-validated CNS targets. The Company's other clinical stage compound is Neboglamine (XY2401), which has completed single dose, and food interaction studies and is in a multi-dose escalation study and is intended for the treatment of patients with schizophrenia. Xytis' drugs are currently in investigational clinical trials and have not been approved for the treatment of any disease.

Source: Xytis

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