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IRVINE, CA
and NYON, SWITZERLAND, March 13, 2007. 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 director 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 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.
For additional information contact:
Vincent F. Simmon, Ph.D.
President and CEO
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