Stallergenes: Staloral(R) Mites 300 Clinical Study in China: Efficacy is Demonstrated

June 21, 2010

ANTONY, France, June 21, 2010 /PRNewswire-FirstCall/ — 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 function.

“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.


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.


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).


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

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


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 immunotherapy products.

    Euronext Paris (Compartment B)
    SBF 120.

    ISIN code: FR0000065674
    Reuters code: GEN.PA
    Bloomberg code: GEN.FP

Additional information is available at http://www.stallergenes.com

(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 severe (4).

(2)IMS Health, Market Prognosis, March 2009 classification in constant US$

SOURCE Stallergenes

Source: newswire

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