Antony, France, June 21, 2010 (ots/PRNewswire)
- Stallergenes S.A.
announces the results of a phase III clinical trial (VO55.06)
conducted in China aimed at assessing the efficacy and safety of
sublingual immunotherapy (Staloral(R) mites 300) in adult patients
suffering from asthma triggered by house dust mites.
Study VO55.06 is a phase III randomized, double-blind,
placebo-controlled study conducted over a period of 15 months in 14
centers located in China's main cities. After an observation period
of 3 months, 484 adult patients with mild to moderate asthma well
controlled under inhaled corticosteroid therapy were divided into two
groups, one treated with Staloral(R) 300 and one given a placebo for
a period of 12 months. Throughout the duration of the study, the
patients received inhaled corticosteroid therapy at gradually reduced
dosages. The patients were assessed on the basis of the level of
asthma control as defined by GINA(1).
Staloral(R) 300 demonstrated statistically significant efficacy
versus placebo for the control of asthma, on the basis of the
following criteria: "well-controlled asthma" and "totally controlled
asthma" in GINA 3 patients (moderate asthma stabilized with
corticosteroids by bronchial route). In this population, the
probability of a patient having his/her asthma well or totally
controlled is more than twice as high with Staloral(R) 300 as it is
in the placebo group (odds ratios and 95% confidence intervals of
2.10 [1.01; 4.36] and 2.43 [1.28; 4.61] respectively).
The treatment was well tolerated. There were no pulmonary side
effects related to worsening of asthma or deterioration in lung
"We are very pleased with the outstanding outcomes of this
large-scale study, conducted in China with a solid methodology. They
pave the way for better asthma management and improved quality of
life for patients", emphasizes Prof. YIN Jia, Principal Coordinator
and Head of the Allergy Department at the Peking Union Medical
College Hospital and President of the Chinese Allergology Society.
"For the first time, the efficacy of sublingual allergen
immunotherapy has been demonstrated in the stabilization of allergic
asthma due to mites in adults through a large-scale clinical trial.
This very good outcome will enable us to apply for registration of
Staloral(R) mites 300 in China in the near future. Obviously, these
results will lead the clinical development program for Actair(R), our
sublingual immunotherapy tablet for the treatment of allergic
rhinitis triggered by dust mites, to also focus on the treatment of
asthma in patients allergic to mites", adds Albert Saporta, Chairman
and CEO of Stallergenes.
ABOUT ALLERGIC ASTHMA
Asthma is a chronic inflammatory disease of the airways, very
often linked to allergic rhinitis: 80% of allergic asthma sufferers
also have allergic rhinitis and 40% of patients with untreated
rhinitis go on to develop asthma.
Particularly common in children, asthma is a major public health
problem. The frequency of the condition varies from one country to
another; in the great majority of developed countries, between 5 and
15% of the adult population and 3 to 7% of the pediatric population
are affected. The prevalence of asthma has been gradually increasing
over the last 20 years in industrialized countries, at a rate of
around 5% per year.
ABOUT RESPIRATORY ALLERGY IN CHINA
The prevalence of respiratory allergy in China ranges from 10 to
more than 20% of the population. The most commonly reported related
conditions are asthma (9.2%), rhinosinusitis (13.3%) and atopic
dermatitis (16.4%). In urban populations, 2 out of 3 allergic
rhinitis sufferers are consulting a physician, and 40% of these will
have allergen tests.
China is one of the countries offering the greatest potential for
economic growth globally in the medium term. It is among the top ten
pharmaceutical markets in the world and is well on the way to
entering the top 5 by 2011(1).
ABOUT STALORAL(R) 300
Staloral(R) 300 is a sublingual solution of allergen extracts for
allergen immunotherapy. It is indicated in the treatment of seasonal
or perennial allergic rhinitis, rhinoconjunctivitis and allergic mild
to moderate asthma in adults and children over the age of 5 years.
Prescribed by allergy specialists, Staloral(R) 300 is particularly
aimed at patients suffering from severe allergic diseases
inadequately controlled despite the use of symptomatic treatments.
The Actair(R) mites immunotherapy tablet is part of the
Stalair(R) sublingual immunotherapy tablet pharmaceutical and
clinical development program being implemented by Stallergenes with a
view to obtaining marketing authorizations for pharmaceutical
products in Europe and in other strategic markets.
Actairâ was the subject of a positive IIb/III trial in allergic
rhinitis in adults in the first half of 2009. A phase III pediatric
trial has been launched.
Stallergenes is a European biopharmaceutical company dedicated to
immunotherapy treatments for the prevention and treatment of
allergy-related respiratory diseases, such as allergic
rhinoconjunctivitis, rhinitis and asthma. Stallergenes is the
seventh-ranked French pharmaceutical company. A pioneer and leader in
sublingual immunotherapy treatments, Stallergenes devotes more than
20% of its turnover, in gross terms, to Research and Development and
is actively involved in the development of a new therapeutic class:
sublingual immunotherapy tablets.
In 2009, Stallergenes had a turnover of 193 million euros and
more than 500,000 patients were treated with Stallergenes
Euronext Paris (Compartment B)
ISIN code: FR0000065674
Reuters code: GEN.PA
Bloomberg code: GEN.FP
Additional information is available at
(1)GINA : Global Initiative on Asthma. GINA, in collaboration
with the National Heart, Lung, and Blood Institute, National
Institute of Health, USA, and the World Health Organization, is
elaborating and updating the worldwide consensus on asthma
management. GINA has defined 4 levels of asthma from mild (1) up to
(2)IMS Health, Market Prognosis, March 2009 classification in
ots Originaltext: Stallergenes
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