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 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 with substantial manufacturing costs and inconvenience for patients.

CYT007-TNFQb is a therapeutic vaccine in development for the treatment of psoriasis and other inflammatory conditions. It is designed to instruct the patient’s immune system to produce an anti- TNF-? antibody response. The induced antibodies aim to bind TNF-? in order to inhibit its inflammatory activity. That way, the subsequent inflammatory process should be slowed down and the deterioration of skin or other tissues reduced.

For further information please contact:
Cytos Biotechnology AG, Wagistrasse 25, CH-8952 Schlieren
Claudine Blaser, PhD
Director Corporate Communications
Tel.: +41 44 733 47 20
e-Mail: claudine.blaser@cytos.com
Webseite: www.cytos.com


About Cytos Biotechnology AG
Cytos Biotechnology AG is a public Swiss biotechnology company that specializes in the discovery, development and commercialization of a new class of biopharmaceutical products – the ImmunodrugsTM. ImmunodrugsTM are intended for use in the treatment and prevention of common chronic diseases, which afflict millions of people worldwide. ImmunodrugsTM are designed to instruct the patient’s immune system to produce desired therapeutic antibody or T cell responses that modulate chronic disease processes. Taking advantage of the high flexibility of its
ImmunodrugTM platform, Cytos Biotechnology has built a pipeline of different ImmunodrugTM candidates in various disease areas, of which 6 are currently in clinical development. The ImmunodrugTM candidates are developed both in-house and together with Novartis and Pfizer Animal Health. Founded in 1995 as a spin-off from the Swiss Federal Institute of Technology (ETH) in Zurich, the company is located in Schlieren (Zurich). Currently, the company has 130 employees. Cytos Biotechnology AG has been listed on the SWX Swiss Exchange (SWX:CYTN) since October 2002.

Posted: May 2007

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