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Wednesday, January 7, 2009

 

Circassia Completes Patient Recruitment for Phase II Clinical Trial of Toleromune(R) Allergy Treatment

Circassia Completes Patient Recruitment for Phase II Clinical Trial of Toleromune(R) Allergy Treatment

OXFORD, England, January 7/PRNewswire/ -- Circassia Ltd, a specialty biopharmaceutical company focused on
allergy and critical care, today announced that following successful clinical
results achieved in 2008 with its ToleroMune(R) anti-allergy technology, the
company has now completed patient recruitment for a further phase II clinical
trial in cat allergy. The study, which is underway in Canada, has recruited
120 patients with confirmed cat allergies, and all the participants have
completed screening and initial dosing with none experiencing any significant
adverse events or safety issues. Circassia anticipates completing patient
dosing in the next three months, with follow-up post-treatment challenge
visits being completed by the end of April 2009.

The double-blind, randomized, placebo-controlled study is
comparing several different ToleroMune treatment regimens, each with
standardised doses administered over several weeks. This is in sharp contrast
to most current allergy immunotherapies, which can require carefully titrated
dosing over many months and even years. As part of the ongoing study, each
patient is exposed to cat allergens in a controlled environmental exposure
chamber both before and after receiving the study treatment. During these
"challenges" the volunteers will monitor and record their allergic rhinitis
symptoms to allow investigators to assess the effect of the ToleroMune
treatment.

"We are delighted that this trial is making such rapid progress
as it should define the optimal treatment approach for our ToleroMune
cat-allergy therapy as it moves towards phase III testing," said Steve
Harris, Circassia's CEO. "We are commited to introducing our ToleroMune
treatment for cat allergy as quickly as possible because, despite its
prevalence, the condition is poorly served by existing therapies due to their
aggressive side-effect profile. ToleroMune offers allergists and their
patients significant potential benefits. In particular, ToleroMune should
greatly simplify and shorten allergy therapy, while minimizing the risk of
the serious and even life-threatening adverse reactions that are associated
with current desensitization treatments."

About Circassia

Circassia is a specialty biopharmaceutical company focused on the fields
of allergy and critical care. The company has a highly experienced management
team with a proven track record in product development and commercialization,
and having successfully completed two fundraising rounds is backed by a
syndicate of world-class venture capital and institutional investors,
including Imperial Innovations, Lansdowne Partners, Goldman Sachs and Invesco
Perpetual.

Circassia's anti-allergy products offer potential important clinical
benefits compared with existing therapies, and consequently have significant
market opportunities. Over 150 million people suffer from allergic rhinitis
in the US and Europe and the market for current treatments is approximately
$12 billion per year. The prevalence of cat allergies is high, with 1-in-6
Americans and nearly 10% of Europeans suffering from the condition.

Circassia's lead products target allergies utilizing the company's
proprietary T-cell epitope desensitization technology, ToleroMune. In
addition to ToleroMune's potential therapeutic benefits, its state-of-the-art
manufacturing processes fit with changes in the regulatory environment in
Europe where authorities are increasingly treating allergen immunotherapies
in the same manner as pharmaceuticals, and eliminating the batch-to-batch
potency variability that is an intrinsic feature of many currrent products.
Circassia is also developing ToleroTrans organ anti-rejection technology,
which uses a similar approach to ToleroMune to down-regulate immune responses
in transplant patients, and ToleroCare therapy which is designed to
dramatically improve patient recovery following a range of high-risk
surgeries.

For more information please visit http://www.circassia.co.uk.

Source: Circassia Ltd

Contacts: Steve Harris, CEO, Circassia, Tel: +44(0)1865-784574; Rob Budge, RJB Communications, Tel: +44(0)1865-760969, Mobile: +44(0)7710-741241


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