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

    OXFORD, England, Jan. 7 /CNW/ - 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
    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
    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

For further information:

For further information: 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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Circassia Ltd

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