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Cytos Reports Results from Phase I/IIa Study with CYT007-TNFQb for,the Treatment of Psoriasis

at the company’s upcoming R&D day on June 20, 2007 at 2 pm (CET) and provide then further details about preclinical and clinical results.


About the combined phase I/IIa study

The multi-centre, randomized, placebo-controlled and double-blind study included 48 male and female patients suffering from moderate to severe plaque psoriasis. An initial part of the study with a total of 24 participants evaluated the safety and tolerability of ascending doses of the vaccine (100 ?g, 300 ?g). It was followed by a second study part with a total of 24 participants that was designed to evaluate exploratory efficacy of the highest previously tested vaccine dose (i.e. 300 ?g) compared to placebo. Patients of this latter group were randomized 1:1 into the vaccine-treated and the placebo group and either received 5 subcutaneous injections of 300 ?g CYT007-TNFQb or placebo at weeks 0, 2, 4, 8 and 12. Upon entry into the study and then every two weeks up to week 16, the patients’ disease severity was determined by the Psoriasis Area and Severity Index (PASI).

About psoriasis and CYT007-TNFQb

Psoriasis is a common chronic skin disorder that affects 1-3% of the world’s population (National Psoriasis Foundation, USA). Plaque psoriasis is the most common form of the disease (>80% of cases) and it is characterized by inflamed red patches of skin topped with silvery white scales. While there are a number of medications that may help to control the symptoms of psoriasis, there is as yet no cure. Psoriasis is considered to be linked to an overactive immune system where inflammatory cytokines play an essential role. The inflammatory cytokine tumor necrosis factor alpha (TNF-?) has been described as a key molecule in the pathogenesis of psoriasis. Consequently, recently approved anti-TNF-? biologics have proven effective; however, they have to be administered frequently and at high doses and are therefore associated
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