IRVINE, CA and NYON, SWITZERLAND,
January 5, 2007. 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."
About Xytis:
Xytis Inc. is a biopharmaceutical company focusing
on the discovery and development of innovative CNS
drug candidates. The company is privately held and
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), GABAA 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.
CEO
