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Cytos Biotechnology AG announced today that it has initiated two phase II clinical trials with the Immunodrug™ CYT003-QbG10, an immunotherapeutic product candidate for the treatment of allergic diseases
SCHLIEREN, Switzerland | November 29, 2007 | Cytos Biotechnology AG (SWX:CYTN) announced today that it has initiated two phase II clinical trials with the Immunodrug™ CYT003-QbG10, an immunotherapeutic product candidate for the treatment of allergic diseases.
One study is a double-blind, placebo-controlled, multicenter study to evaluate safety, tolerability and efficacy of increasing doses of CYT003-QbG10 monotherapy. This trial will include 64 patients with perennial allergic rhinoconjunctivitis due to house dust mite and/or cat allergy. The second study is also a double-blind, placebo-controlled, multicenter study and will evaluate safety, tolerability and efficacy of a specific immunotherapy combining allergen extract of house dust mites with CYT003- QbG10 (designated as CYT005-AllQbG10) or placebo. The second trial will include 100 patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy. In both studies, efficacy of the immunotherapy will be evaluated by means of the conjunctival provocation test. First results of the studies are expected midyear 2008.
The decision to initiate the two phase II clinical trials is based on positive efficacy results for this Immunodrug™ candidate from earlier phase IIa studies where CYT003-QbG10 was applied as a monotherapy and in combination with allergen extracts. The present studies are aimed at testing the two approaches in larger patient populations in order to select the best product candidate for latestage development in this important therapeutic area.
About CYT003-QbG10 / CYT005-AllQbG10
CYT003-QbG10 is an immunotherapeutic product in development for the treatment of allergy and asthma. It is based on Cytos Biotechnology’s second Immunodrug™ platform, which applies immunostimulatory DNA sequences to induce targeted T cell responses. CYT003-QbG10 encompasses the virus-like particle Qb, which has been filled with the immunostimulatory DNA sequence G10 - a synthetically produced stretch of DNA originally derived from bacteria. CYT003-QbG10 is designed as a disease-modifying treatment and aims to induce a potent Th1 type immune response in order to suppress an “allergic” Th2 type immune response. Initial clinical observations indicate that CYT003- QbG10 monotherapy could act by an allergen-independent mechanism of action so that it has potential as a treatment for a broad range of different allergic diseases. In the context of an allergen-specific immunotherapy, CYT003-QbG10 combined with a standard dose of house dust mite allergen extract (designated CYT005-AllQbG10) achieved excellent long-term efficacy in patients allergic to house dust mites
About allergic diseases
Allergy as a whole is a multi-faceted disease and clinically manifests in various allergic disorders including allergic rhinitis, asthma, 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. According to the World Health Organization, more than 20% of the world population suffers from allergic diseases1.
Allergy to house dust mites is one of the most common causes of allergic disease worldwide and it is estimated that nearly 50% of allergic people are sensitized to dust mite allergens2. Cat allergy is the most common pet allergy and an important cause of allergic asthma exacerbations. About 30% of asthmatics are sensitized to cats3.
Today, three general approaches are commonly being pursued 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 treatment available offers just short-term amelioration of the disease. For patients this may mean chronic use of corticosteroids and antihistamines – often with multiple daily doses. Desensitization on the other hand is very time-consuming (3-5 years) and with up to 80 allergen injections inconvenient for the patient. It is, however, the only curative treatment available that reduces disease symptoms over a longer period of time. A significant unmet medical need remains for allergic disease treatment.
About Cytos Biotechnology
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 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 full pipeline of different Immunodrug™ candidates in various disease areas, of which 6 are currently in clinical development. The Immunodrug™ 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 2007-11-30
References
1 World Health Organization (WHO), Prevention of Allergy and Allergic Asthma, 2003.
2 Clinical and Experimental Allergy, 2004; 34:597.
3 Journal of Allergy and Clinical Immunology, 2007; 120:1139.
SOURCE: Cytos Biotechnology AG
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