DGAP-News: Cytos Biotechnology AG: CYT003-QbG10 monotherapy for the treatment of allergic rhinoconjunctivitis is safe and efficacious in phase IIb study
Cytos Biotechnology AG / Research Update
31.07.2009
Release of a Corporate News, transmitted by DGAP - a company of EquityStory AG.
The issuer / publisher is solely responsible for the content of this announcement.
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- Study meets primary and both secondary endpoints
Schlieren (Zurich), Switzerland, July 31, 2009 - Cytos Biotechnology Ltd
(SIX:CYTN) today announced that a phase IIb study with CYT003-QbG10
monotherapy for the treatment of allergic rhinoconjunctivitis met its
primary and both secondary endpoints. The study was a randomized,
double-blind, placebo-controlled, multicentre, phase IIb study and included
299 patients suffering from house dust-mite allergy. It investigated the
safety, tolerability and efficacy of six weekly injections of CYT003-QbG10
given at two dose levels (0.5 mg and 1 mg) and placebo.
Primary efficacy was assessed by recording rhinoconjunctivitis symptom and
medication scores in patient diaries over a 14 day period. Secondary
efficacy parameters were quality of life with rhinoconjunctivitis assessed
by a validated questionnaire, and change in allergen tolerance determined
by a standard conjunctival provocation test.
The combined symptom and medication score based on diary card records is
the standard clinical parameter for the assessment of allergic disease
severity and recommended by the World Allergy Organization (WAO) (1). In
the 1 mg group patients had post-treatment a 39% lower median combined
symptom and medication score than patients on placebo (p=0.035). While
allergy symptoms were significantly lower in the 1 mg group than in the
placebo group (p=0.027), medication use was generally low and did not
differ significantly between the two groups.
Quality of life with rhinoconjunctivitis was determined by a validated
questionnaire (Juniper miniRQLQ), which investigates five items (nose
symptoms, eye symptoms, other symptoms, practical problems, activity
limitations). Post treatment, patients in the 1 mg group reported a median
42% better quality of life score than patients on placebo (p=0.020).
The conjunctival provocation test establishes the dose of allergen which
can be tolerated by patients with minimal allergic symptoms. In this test,
patients are exposed to increasing doses of allergen extract delivered by
an eye drop, and the dose is recorded which induces a defined minimal
allergic response. Post treatment, the median allergen tolerance was
10-fold increased in the 1 mg group but remained unchanged in the placebo
group (p=0.007).
Symptom and medication scores, quality of life, and allergen tolerance were
all better in the 1 mg group than in the 0.5 mg group post treatment. In
the low dose group, the difference to placebo reached statistical
significance in the quality of life score and was numerically better in the
symptom and medication score.
Treatment at both dose levels was safe and well tolerated. Importantly, no
dose limiting side effects were observed, which may enable the use of
higher doses in future studies.
Detailed study results will be presented at an upcoming scientific
conference.
Dr. Wolfgang Renner, CEO of Cytos Biotechnology Ltd commented the study
results: ‘These new results confirm the safety and efficacy of QbG10
monotherapy for the treatment of allergic rhinoconjunctivitis. With the
completion of the ongoing phase II study in allergic asthma in Q1 2010, the
early development phase will be finalized and the product should be highly
attractive for partnering with a leading pharmaceutical company. QbG10 has
the prospect of becoming the first allergen-independent disease modifying
therapy for allergic diseases with the potential to address significant
unmet medical need in an indication which affects large portions of our
society'.
About CYT003-QbG10
CYT003-QbG10 is an immunotherapeutic product in development for the
treatment of allergy and asthma. It is based on Cytos Biotechnology's
modified Immunodrug(TM) platform, which applies immunostimulatory DNA
sequences to induce targeted T cell responses. The immunotherapeutic
encompasses the virus-like particle Qb, which is filled with the
immunostimulatory DNA sequence G10 - a synthetically produced stretch of
DNA originally derived from bacteria. This DNA sequence is recognized by so
called toll-like receptors, an evolutionary ancient class of receptors that
detect microbial patterns and serve as the first line of defense of the
immune system. CYT003-QbG10 aims to alter the immunological milieu and the
allergic immune cell responses to ameliorate disease symptoms. In contrast
to current marketed immunotherapy approaches, which are all based on
allergen components, CYT003-QbG10 is free of allergen and is thought 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.
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 feces, or food. Allergy is a very common chronic disease, and its
prevalence has increased dramatically within the last few decades. Today,
more than 20% of the world population suffers from allergic diseases (2),
and Europe alone has 80 million allergy sufferers (3). House dust mites and
cats represent the two 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 only offers 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, it is also inconvenient for the patient,
so that only few allergy sufferers take advantage of this therapy.
Conference call today at 3.00 pm (CET)
Cytos Biotechnology will host a conference call and Q&A session today,
Friday, July 31, 2009, at 3.00 pm (CET) to discuss the study findings.
To access the conference call, please dial the following numbers:
Europe +41 (0) 91 610 56 00
U.S. +1 (1) 866 291 41 66
U.K. +44 (0) 207 107 06 11
The conference call will also be accessible by webcast on the internet. You
may follow the call live or have it replayed later on demand. To access the
webcast and the presentation, please follow the link provided on the
company's home page www.cytos.com. The conference will be held in English
and the presentation slides will be available for download 30 minutes prior
to the conference.
Glossary
Allergen: a normally harmless substance that elicits a misdirected immune
response.
Allergic asthma: chronic inflammation and obstruction of the airways of the
lungs caused by exposure to allergens.
Conjunctival: relating to the conjunctiva, the mucous membrane that lines
the inner surface of the eyelid and the exposed surface of the eyeball.
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 an earlier regimen where QbG10 was combined to allergen extract
(i.e. CYT005-AllQbG10).
Placebo: dummy medical treatment.
QbG10: Cytos Biotechnology's Immunodrug(TM) Qb filled with the
immunostimulatory DNA sequence G10.
Rescue medication: during the study, patients are provided access to
specified medications to alleviate allergy symptoms if needed.
Rhinoconjunctivitis: combination of rhinitis (inflammation of the nasal
mucosa) and conjunctivitis (inflammation of the mucous membrane of the
eye).
Symptom and medication scores: Symptoms and concomitant medication use
during the study are recorded on individual diary cards during a defined
period of time.
References
(1) Recommendations for standardization of clinical trials with
allergen-specific immunotherapy for respiratory allergy. A statement of a
World Allergy Organization (WAO) taskforce; Allergy, 2007; 62:317, and
Assessment of combined symptom and medication scores for
rhinoconjunctivitis immunotherapy clinical trials; Allergy, 2007; 62:1023.
(2) World Health Organization; Prevention of Allergy and Allergic Asthma,
January 2002.
(3) GA2LEN - Global Allergy and Asthma European Network, 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(TM). Immunodrugs(TM)
are intended for use in the treatment and prevention of common chronic
diseases, which afflict millions of people worldwide. Immunodrugs(TM) 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(TM)
platform, Cytos Biotechnology has built a diversified pipeline of
Immunodrug(TM) candidates in various disease areas, of which six are
currently in clinical development. The Immunodrug(TM) 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 90 full-time employees.
Cytos Biotechnology Ltd is listed on the SIX Swiss Exchange (SIX:CYTN).
This foregoing press release may contain forward-looking statements that
include words or phrases such as ‘may', ‘will', ‘would', 'should', ‘can',
‘designed', ‘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
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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.