Start Of Phase IIb Clinical Study With CYT003-QbG10 Monotherapy For The Treatment Of Allergic Diseases

Main Category: Allergy
Also Included In: Respiratory / Asthma
Article Date: 10 Dec 2008 - 8:00 PDT

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Cytos Biotechnology Ltd (SIX:CYTN) announced today that it has started a phase IIb clinical study with CYT003-QbG10, an allergen-independent immunotherapeutic product candidate for the treatment of allergy and asthma. The study is a randomized, double-blind, placebo-controlled, multicenter dose-finding study to evaluate the safety, tolerability and efficacy of two different doses of CYT003-QbG10. It will include 300 patients with rhinoconjunctivitis due to house dust mite allergy. First results of the study are expected to be available in the third quarter of 2009.

CYT003-QbG10 is based on Cytos Biotechnology's modified Immunodrug™ platform, which encompasses the virus-like particle Qb filled with the immunostimulatory DNA sequence G10. CYT003- QbG10 is designed as a disease-modifying treatment and aims to alter the immunological milieu and the allergic immune cell responses to ameliorate disease symptoms. In contrast to current immunotherapy approaches, which are all based on allergen components, CYT003-QbG10 monotherapy is free from allergen and is thus anticipated to act through an allergen-independent mechanism. The use of a single allergen-independent agent would not only simplify treatment for multiple allergies but also improve tolerability by avoiding allergen-induced side effects. CYT003- QbG10 has previously been demonstrated to be safe, very well tolerated and efficacious in lowering the total rhinoconjunctivitis symptom score in daily life.

About allergic diseases

Allergy as a whole is a multi-faceted disease and manifests itself clinically in various allergic disorders including allergic rhinoconjunctivitis, asthma, eczema and food hypersensitivity. It is an exaggerated reaction by the patient's immune system to a normally harmless substance such as various environmental proteins present in pollen, dust mite faeces, or food. Allergy is a very common chronic disease and its prevalence has increased considerably within the last few decades. Today, more than 20% of the world population suffers from allergic diseases1, and Europe alone has over 80 million allergy sufferers2. House dust mites represent one of the most important allergen sources for perennial allergies.

There are three general approaches being pursued today to relieve the symptoms of allergic diseases: avoidance of the allergen whenever possible, prescription of medication that targets disease symptoms and conventional immunotherapy, also known as desensitization. Symptomatic medication offers only short-term amelioration of the disease. For patients this may mean chronic use of corticosteroids and antihistamines - often with multiple daily doses. Conventional immunotherapy, on the other hand, is very time-consuming (3-5 years) and with up to 80 allergen injections also inconvenient for the patients. Therefore, only few allergy sufferers take advantage of this therapy.

References

1 World Health Organization; Prevention of Allergy and Allergic Asthma, January 2002.
2 GA2LEN - Global Allergy and Asthma European Network, http://www.ga2len.net, 2008.

About Cytos Biotechnology

Cytos Biotechnology Ltd is a public Swiss biotechnology company that specializes in the discovery, development and commercialization of a new class of biopharmaceutical products - the Immunodrugs™. Immunodrugs™ are intended for use in the treatment and prevention of common chronic diseases, which afflict millions of people worldwide. Immunodrugs™ 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 Immunodrug™ platform, Cytos Biotechnology has built a diversified pipeline of different Immunodrug™ candidates in various disease areas, of which 5 are currently in clinical development. The Immunodrug™ candidates are developed both in-house and together with Novartis, Pfizer and Pfizer Animal Health. Founded in 1995 as a spinoff from the Swiss Federal Institute of Technology (ETH) in Zurich, the company is located in Schlieren (Zurich). Currently, the company has 133 employees. Cytos Biotechnology Ltd is listed on the SIX Swiss Exchange (SIX:CYTN). http://www.cytos.com/

Glossary

-- Allergen: a normally harmless substance that elicits a misdirected immune response.
-- Diseases-modifying: in contrast to symptomatic treatment, a disease-modifying treatment aims at addressing the cause of disease and modifying the disease progression.
-- Double-blind: a set-up often used in clinical trials where neither the doctor nor the patients know if placebo or the active drug is applied.
-- Immunostimulatory: able to stimulate the immune system.
-- Immunotherapy / immunotherapeutic: a therapy / a medication aimed at activation of the immune system to modulate a certain disease process.
-- Monotherapy: treatment with one drug as opposed to combination therapy. Here the term refers to treatment with QbG10 alone (i.e. CYT003-QbG10) in contrast to a regimen where QbG10 was combined to allergen extract (i.e. CYT005-AllQbG10).
-- Phase IIb: clinical trial that examines a new drug candidate's safety, tolerability and efficacy in a larger group of patients.
-- Placebo: dummy medical treatment.
-- QbG10: Cytos Biotechnology's Immunodrug™ Qb filled with the immunostimulatory DNA sequence G10.
-- Randomized: random assignation of study participants to different treatment groups.
-- Rhinoconjunctivitis: combination of rhinitis (inflammation of the nasal mucosa) and conjunctivitis (inflammation of the mucous membrane of the eye).

This foregoing press release may contain forward-looking statements that include words or phrases such as "expected", "designed", "aim", "anticipated", "will", "would", "may", "intend" or other similar expressions. These forward-looking statements are subject to a variety of significant uncertainties, including scientific, business, economic and financial factors, and therefore actual results may differ significantly from those presented. There can be no assurance that any further therapeutic entities will enter clinical trials, that clinical trial results will be predictive for future results, that therapeutic entities will be the subject of filings for regulatory approval, that any drug candidates will receive marketing approval from the U.S. Food and Drug Administration or equivalent regulatory authorities, or that drugs will be marketed successfully. Against the background of these uncertainties readers should not rely on forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of Cytos Biotechnology Ltd.

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