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