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

Wednesday, January 7, 2009 General News
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OXFORD, England, January 7 Circassia Ltd, a specialtybiopharmaceutical company focused on allergy and critical care, todayannounced that following successful clinical results achieved in 2008 withits ToleroMune(R) anti-allergy technology, the company has now completedpatient recruitment for a further phase II clinical trial in cat allergy. Thestudy, which is underway in Canada, has recruited 120 patients with confirmedcat allergies, and all the participants have completed screening and initialdosing with none experiencing any significant adverse events or safetyissues. Circassia anticipates completing patient dosing in the next threemonths, with follow-up post-treatment challenge visits being completed by theend of April 2009.

The double-blind, randomized, placebo-controlled study is comparingseveral different ToleroMune treatment regimens, each with standardised dosesadministered over several weeks. This is in sharp contrast to most currentallergy immunotherapies, which can require carefully titrated dosing overmany months and even years. As part of the ongoing study, each patient isexposed to cat allergens in a controlled environmental exposure chamber bothbefore and after receiving the study treatment. During these "challenges" thevolunteers will monitor and record their allergic rhinitis symptoms to allowinvestigators to assess the effect of the ToleroMune treatment.

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

About Circassia

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

Circassia's anti-allergy products offer potential important clinicalbenefits compared with existing therapies, and consequently have significantmarket opportunities. Over 150 million people suffer from allergic rhinitisin 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-6Americans and nearly 10% of Europeans suffering from the condition.

Circassia's lead products target allergies utilizing the company'sproprietary T-cell epitope desensitization technology, ToleroMune. Inaddition to ToleroMune's potential therapeutic benefits, its state-of-the-artmanufacturing processes fit with changes in the regulatory environment inEurope where authorities are increasingly treating allergen immunotherapiesin the same manner as pharmaceuticals, and eliminating the batch-to-batchpotency 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 responsesin transplant patients, and ToleroCare therapy which is designed todramatically improve patient recovery following a range of high-risksurgeries.

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SOURCE Circassia Ltd

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