Navigation Links
STALLERGENES: Persistent Efficacy Demonstrated After a Year on Actair(R) Followed by a Second Treatment-Free Year

ANTONY, France, June 28, 2010 /PRNewswire-FirstCall/ -- After having announced positive results for the first year of its phase IIb/III clinical trial (VO 57.07) conducted on Actair(R) sublingual allergen immunotherapy tablets in allergic rhinitis triggered by house dust mites in April 2009, Stallergenes S.A. today announces the results of the second year of this study.

Following this first year which demonstrated positive results for both the dosages tested (300 IR[1] and 500 IR) and which is key for the marketing authorization application, the second year of the study involved an exploratory evaluation of the persistence of the therapeutic effect of Actair(R) in the following year. Out of the 509 patients originally included in the study, 397 participated until the end of the second year. The primary endpoint for this second year was the Average Adjusted Symptom Score (AAdSS)[2] measured one year after the end of treatment.

The results of this second year demonstrate not only that the efficacy of Actair(R) persists well beyond the first six months after treatment is stopped but also that the size effect is globally equivalent to that observed in the first year. Thus in the main assessment period for the efficacy endpoint (between 10 and 12 months after the discontinuation of treatment), both active groups demonstrated a persistent effect of the treatment, with a statistically significant difference for the AAdSS versus placebo [(p=0.0342) for the 300 IR dosage; (p=0.0229) for the 500 IR dosage], still with no difference between the two treated groups.

This study is a world first in that, for the first time, it indisputably demonstrates the persistence of the effect of sublingual allergen immunotherapy in perennial allergic rhinitis triggered by house dust mites, as well as the early onset of this effect, from the end of the first year. The duration and the dynamics of this effect will have to be explored.

"We're clearly delighted with these results. For the first time ever, the persistence of the therapeutic effect of allergen immunotherapy has been demonstrated after only a year. This is yet another illustration of the contribution that the large-scale studies conducted as part of the Stalair(R) clinical development program can make to our understanding of allergen immunotherapy", says Albert Saporta, Chairman and CEO of Stallergenes. "Like the trial conducted in asthma triggered by house dust mites with Staloral(R) 300 in China, this study will help us construct a development plan for Actair(R) that is ambitious in terms of the indications envisaged and realistic, proposing discontinuous protocols that meet the expectations of both patients and health system paying authorities."


In Europe, almost 40% of allergic respiratory diseases, on average, are triggered by house dust mites, making this the leading cause of respiratory allergy, ahead of grass pollens. Dust mites are responsible for allergic rhinitis that begins in early childhood, gradually worsens over time and naturally progresses to asthma. These conditions have marked symptoms that significantly impair patients' quality of life.


Stalair(R) is the name of the pharmaceutical and clinical development program for immunotherapy tablets being implemented by Stallergenes with a view to obtaining market authorizations for pharmaceutical products in Europe and in other strategic markets.

Oralair(R) is the first project resulting from this program. A Mutual Recognition Procedure has been completed in Europe. Having recently demonstrated its efficacy after 3 years of treatment (study VO53.06 conducted in Europe), Oralair(R) has been the subject of a positive phase III trial in adults in the United States (VO61.08).

The second project in the program is Actair(R), dust mite immunotherapy tablet. Following the results of the first year of the phase IIb/III study in allergic rhinitis in adults, a phase III pediatric study has been launched.

The Stalair(R) r Bet v 1 tablet (birch pollen recombinant allergen) has been the subject of a positive phase IIb/III clinical trial conducted in allergic rhinitis caused by birch pollen. A confirmatory phase III study is currently being prepared with a view to EMA registration.

The other allergens concerned by the program are ragweed pollen for the North American market and Japanese cedar pollen for the Japanese market. Altogether, the program covers 80% of the epidemiology for all markets.


Staloral(R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. It is indicated in the treatment of allergic rhinitis, rhinoconjunctivitis and seasonal or perennial mild to moderate allergic 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 by the use of symptomatic treatments.

In the context of a phase III clinical trial (VO55.06) conducted in China, Staloral(R) 300 has demonstrated its efficacy in the control of asthma triggered by house dust mites on the basis of "well-controlled asthma" and "total asthma control" criteria in adult GINA 3 patients (moderate asthma stabilized by inhaled corticosteroids).


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.

[1] Reactivity index for standardized extracts

[2] AAdSS: Average Adjusted Symptom Score taking into account the total daily rhinoconjunctivitis symptom score and recourse to authorized rescue treatments.

    Euronext Paris (Compartment B)
    SBF 120.

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

    Additional information is available at:

SOURCE Stallergenes
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Stallergenes: Oralair: Very Positive 3-Year Results of the Long-Term Study
2. STALLERGENES: Oralair(R) Grasses Obtains a Pediatric MA(1) in Germany
3. Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber
4. FDA Approves New Device for Adults with Severe and Persistent Asthma
5. Fovea Reports Positive Results with Prednisporin(TM) in Persistent Allergic Conjunctivitis
6. Study Shows Potential Benefits of Xolair(R) in Treating Children Suffering from Moderate or Severe Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
7. Study Analyzed SYMBICORT(R) in Children with Persistent Asthma
8. New Data Demonstrated Efficacy and Safety of Initial Combination Therapy with Welchol(R) (colesevelam HCl) and Metformin in Drug-Naive Adult Type 2 Diabetes Patients
9. New Data Demonstrate Safety, Efficacy of Stereotaxis for Patients with AFIB, VT and Congenital Defects
10. FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
11. The Lancet publishes new data demonstrating superior efficacy of Victoza(R) (liraglutide [rDNA] injection) compared to Januvia(R) (sitagliptin) in the treatment of type 2 diabetes
Post Your Comments:
(Date:11/24/2015)... Nueva York , 24 de noviembre de ... del Avery Breathing Pacemaker System, se complace anunciar ... Ph.D. como consultor clínico. ... Foto -   ... Jonzon es un fisiólogo y consultor en neonatología ...
(Date:11/24/2015)... NEWS, Va. , Nov. 24, 2015  DILON ... they have signed an agreement for DILON to distribute ... geographies across the globe. The signing of this distribution agreement ... Discovery NM750b Molecular Breast Imaging system and is considered ... to provide better healthcare solutions for clinicians and their ...
(Date:11/24/2015)... 24, 2015 Sectra (STO: SECT ... entered into a multi-year agreement to deploy Breast ... will provide the Breast Center a future-proof platform capable ... (STO: SECT B) announces that Breast Center of Acadiana ... Breast Imaging PACS in its two freestanding imaging centers. ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Castlewood Treatment Center for ... eating disorders as a result of the $20,000 raised at the center’s recent ... Run Golf Club in Eureka, will help individuals who otherwise might not seek ...
(Date:11/25/2015)... ... ... Many people know of the common symptoms of low thyroid hormone (also ... many people who find their cholesterol levels and weight are creeping up are more ... they don’t have any of the other symptoms. , Thyroid hormone plays a major ...
(Date:11/24/2015)... ... November 25, 2015 , ... Genesis Chiropractic Software helps practice ... an agreement between the practice owner and the patient that automatically manages all ... projections. Click here to learn more. , According to ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Charitable giving is ... donations are made in the last five weeks of the year totalling over $358 ... in 2012 to connect the nation’s charities with those individuals who want to “give ...
(Date:11/24/2015)... ... 2015 , ... The hospitals and health systems on this ... care. They have received recognition for excellence from various reputable organizations in areas ... Hospital Review selected hospitals for inclusion based on national rankings and awards from ...
Breaking Medicine News(10 mins):