Kuzi Generics

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 Buy clomid without prescription World Health Organization; Prevention of Allergy and Allergic Asthma, January 2002.
2 GA2LEN - Global Allergy and Asthma European Network, 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).
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.
Cytos Biotechnology
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