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

Schlieren (Zurich), Switzerland, May 24, 2007 - Cytos Biotechnology AG (SWX:CYTN) reported today results from a placebo-controlled, double-blind combined phase I/IIa study with CYT007-TNFQb, a novel vaccine candidate for the treatment of psoriasis and other inflammatory conditions. The present study was a first-time-in-man clinical trial and included 48 patients suffering from moderate to severe plaque psoriasis. In a first part of the study, the safety and tolerability of ascending doses of CYT007-TNFQb were assessed in 24 patients. In the following second part of the study, the exploratory efficacy of the highest vaccine dose was compared to placebo in another 24 patients.

All doses of CYT007-TNFQb tested were safe and well tolerated. All the patients who received the vaccine mounted an antibody response against TNF-?. Exploratory efficacy was assessed according to the Psoriasis Area and Severity Index (PASI), a commonly used measure to evaluate the disease severity in psoriatic patients. The graph below shows the course of the PASI scores throughout the study period (i.e. from baseline up to week 16) for the CYT007-TNFQb-treated and the placebo group.


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Dr. Wolfgang Renner, CEO of Cytos Biotechnology, commented the study results: “The prime objective of this first-time-in-man clinical trial was to demonstrate safety and tolerability of this novel vaccine candidate. This objective was clearly reached. With regard to efficacy we are seeing a temporary improvement of the disease. We will now in detail analyse a broad set of biochemical markers in order to determine whether this observed improvement of disease is indeed treatment related. This additional analytical and laboratory work, which will take several months to complete, will then guide us in the further development of this novel vaccine candidate.”

Cytos Biotechnology will discuss the development program for CYT007-TNFQb
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