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Schlieren (Zurich), Switzerland, December 14, 2005 - Cytos Biotechnology AG (SWX:CYTN) announced today that it has initiated a further phase IIa clinical trial with the Immunodrug™ candidate CYT005-AllQbG10, a therapeutic vaccine for the treatment of allergic diseases. The study will include 36 patients with mild to moderate allergic rhinoconjunctivitis due to grass pollen allergy (hay fever). One part of the study is a randomized, double-blind and placebo-controlled (allergen alone) trial with 18 patients, which will assess safety, tolerability and efficacy of a 10-weeks treatment regimen with the vaccine. The second part of the study is open-label and exploratory and will evaluate safety, tolerability and efficacy of further shortened treatment regimes with the vaccine. First results of the study are expected in the second quarter of 2006.
The decision to initiate clinical development for CYT005-AllQbG10 in additional allergy indications was based on recent positive results from the phase IIa study with CYT005-AllQbG10 in patients with house dust mite allergy.
About allergic diseases
Allergy as a whole is a widespread disease that ranges from hay fever (seasonal allergic rhinitis) to seriously life threatening forms of asthma and anaphylaxis. According to the World Health Organization, more than 20% of the world population suffers from allergic diseases (WHO, 2002). An allergic reaction in general is caused by hypersensitivity of the immune system to a normally harmless substance, the so called allergen, causing a misdirected, so called Th2 type immune response. Today, three general approaches are being pursued to relieve the symptoms of allergic diseases: avoidance of the allergen, prescription of medication that targets allergy symptoms, and specific immunotherapy, also known as desensitization, which is the only disease-modifying treatment available today and which reduces the allergy symptoms over a longer period of time. A typical desensitization therapy, however, can consist of up to 80 allergen injections over three years and is thus time-consuming, costly, and inconvenient for the patient.
About CYT005-AllQbG10
CYT005-AllQbG10 is a therapeutic vaccine in development for treatment of allergic diseases. The vaccine is currently being tested for treatment of house dust mite allergy and grass pollen allergy. Grass pollen is one of the most frequent causes of seasonal allergic rhinitis (hay fever) starting in spring every year and affecting 15-20% of the European population (WHO Europe, 2003).
CYT005-AllQbG10 is comprised of the ImmunodrugTM carrier QbG10 mixed with a natural allergen extract of choice - grass pollen allergen extract for this study. QbG10 itself consists of the virus-like particle Qb filled with an immunostimulatory sequence called G10. QbG10 is believed to act as a potent adjuvant enhancing the establishment of a "non-allergic" Th1 type immune response. Th1 type immune responses have been shown to suppress "allergic" Th2 type immune responses. CYT005- AllQbG10 thus aims at induction of such a Th1 type immune response to balance an existing Th2 type immune response. As such, CYT005-AllQbG10 is thought to act as a causal and disease-modifying vaccine to treat allergy.
By combination of the classical desensitization approach with the carrier QbG10, the complete desensitization campaign could be shortened from three years duration to less than three months when using CYT005-AllQbG10. The positive results obtained for CYT005-AllQbG10 from the phase IIa house dust mite allergy study support this anticipation. This should be much more convenient for the patient and has the potential to become a more widely used allergy treatment than conventional desensitization. ImmunodrugTM candidates based on QbG10 could likewise be applied for treatment of a wide range of other allergies, when QbG10 is combined with other allergens.
Glossary
Adjuvant: a substance that non-specifically enhances the immune response.
Allergen: a normally harmless substance that elicits a misdirected immune response.
Allergic rhinitis: a condition due to allergy that mimics a chronic cold. Rhinitis means "irritation of the nose".
Desensitization: a certain form of immune therapy applied to treat allergy.
Double-blind: a set-up often used in clinical trials where neither the doctor nor the patient knows if placebo or the active drug is applied.
Efficacy: strength, effectiveness; the ability of a drug to control or cure an illness.
Open-label: a set-up used in clinical trials where the doctor and the patient know what substance is administered.
Phase IIa: a clinical trial that examines a new drug candidate's safety and preliminary efficacy in the targeted population and involves approximately 10-100 people.
Placebo: dummy medical treatment.
Randomized: random assignation of clinical trial participants to different treatment groups.
Regimen: describes the time schedule according to which a drug is administered.
Rhinoconjunctivitis: a combination of rhinitis (inflammation of the nose) and conjunctivitis (inflammation of the eye).
Th1 and Th2 type responses: describe a subset of T helper cell responses. T helper cells are a subset of T cells that secrete a variety of mediators (cytokines) playing a role in activation of other immune cells. A Th1 type immune response is usually induced by viral infection, or also by potent vaccination. A Th2 type immune response usually manifests an allergic reaction.
Therapeutic vaccine: a preparation of disease-related molecules (antigens) that is capable of inducing an immune response to such antigens with the goal to modulate the disease process.
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 cytotoxic 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 28 different ImmunodrugTM candidates in various disease areas, of which eight are currently in clinical development. The Immunodrug™ candidates are developed both in-house (25) and together with Novartis (1) and Pfizer Animal Health (2). 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 121 employees. Cytos Biotechnology AG has been listed on the SWX Swiss Exchange (SWX:CYTN) since October 2002.
For further information please contact:
Dr. Claudine Blaser
Director Corporate Communications
Phone: +41 44 733 47 20
Fax: +41 44 733 47 18
e-Mail: claudine.blaser@cytos.com
Website: www.cytos.com
This foregoing press release may contain forward-looking statements that include words or phrases such as "will", "is thought", "aim", "could", "should", "has potential", "anticipation", "intend", "designed" 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 other 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 AG. |
