Circassia
Initiates Further Phase II Clinical Study Of
Toleromune(R) Anti Allergy Technology
Circassia Ltd, a specialty biopharmaceutical company
focused on the fields of allergy and critical care,
today announced the start of a further phase II clinical
study of its ToleroMune(R) technology in the field
of cat allergy. The trial builds on positive results
achieved in an earlier phase II study, which demonstrated
the potential clinical benefits of the ToleroMune
approach to allergy desensitization.
In the previous phase II clinical trial, patients
experienced substantially reduced reactions to cat
allergens after a single administration of ToleroMune
therapy. The current study builds on this work, and
will explore different 4-dose treatment regimens,
which are designed to enhance the patients' response
and determine the best therapeutic approach. During
the study, patients will receive a controlled dose
of cat allergen in an environmental exposure chamber
both before and after treatment, and will then complete
a questionnaire to score their allergic rhinitis
symptoms. This will allow investigators to evaluate
the impact of the different treatment regimes. The
double-blind, randomized, placebo-controlled trial
will include a total of 120 volunteers with confirmed
cat allergies. The study, which is already underway
in Canada, is progressing well with approximately
20% of patients enrolled for screening so far.
"This study is of great importance for Circassia
as it is designed to define the most effective treatment
regime for our ToleroMune allergy products, and in
particular for the phase III studies of our cat-allergy
therapy that are planned to begin in the second half
of 2009," said Steve Harris, Circassia's CEO. "The
results of our trials to date show that our ToleroMune
approach offers patients substantial potential benefits.
Conventional allergy treatments either address symptoms
only or require many doses over a period of months
under specialist supervision because they can result
in serious, even life-threatening adverse reactions.
In contrast, Circassia's anti-allergy technology
has the potential to provide effective but shorter
treatments, while minimizing the threat of severe
side-effects."
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 lead products target allergies utilizing
the company's proprietary T-cell epitope desensitization
technology, ToleroMune. The company is also developing
its ToleroTrans organ anti-rejection technology,
which uses a similar approach to down-regulate immune
responses in transplant patients.
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 also
high, with 1-in-6 Americans and nearly 10% of Europeans
suffering from the condition.
