STALLERGENES: Immunotherapy Tablet Containing Recombinant Allergen (rBet v 1) of Birch Pollen: Positive Results for a Phase IIb/III Trial
has announced the first results of a new phase IIb/III clinical trial
(VO59.08) conducted in allergic rhinitis caused by birch pollen and
concerning the development of a sublingual immunotherapy tablet containing
the recombinant allergen of this pollen, rBet v 1.
This study is the first ever to use a recombinant allergen as an active
substance. To Stallergenes’ knowledge, the use of a recombinant protein in
dry form is also a world first.
The VO59.08 study, conducted during the 2009 pollen season, was a
randomized, double-blind, placebo-controlled trial. It included 483 adult
patients allergic to birch pollen and suffering from rhinoconjunctivitis
symptoms in 30 centers in 8 different countries. The patients were divided
into 4 groups: 3 groups treated with sublingual tablets containing 12.5
microg, 25 microg and 50 microg of rBet v 1, respectively, with no
dose-titration phase, and one group receiving placebo.
The primary endpoint for analysis of the results was the reduction in
average adjusted symptom score (AASS). The 3 treated groups demonstrated a
statistically significant reduction in AASS in comparison with placebo
(0.002<p<0.03) of approximately 25% over the season as a whole and
approximately 30% at its peak. The overall tolerance was very good, notably
for the 12.5 microg and 25 microg dosages.
“This study conducted by Stallergenes marks a very important milestone in
immunotherapy. It is the first time that clinical development with a
regulatory objective has been undertaken with a recombinant allergen.
Analysis of all the results should make it possible to select the optimum
dose and to define the conditions for the confirmatory phase III study that
will be conducted with a view to filing a centralized marketing authorization
application with the EMEA.
The rBet v 1 program, launched in 2003 with the signature of a licensing
agreement for rBet v 1 produced by Biomay has represented an unprecedented
pharmaceutical development effort, together with our manufacturing partner
CMC Biologics” says
“We are excited and proud to be part of the rBet v 1 innovative program.
As a partner to Stallergenes, CMC is committed to the challenge of producing
the world first major recombinant allergens on a large scale” says
ABOUT BIRCH POLLEN ALLERGY
Very common in
birch pollen exceeds 20% in some large cities.
The birch pollen season is short – lasting just 1 to 2 months – but
intense, and precedes the grass pollen season.
ABOUT THE STALAIR(R) PROGRAM
Stalair(R) is the pharmaceutical and clinical development program for
immunotherapy being implemented by Stallergenes with a view to obtaining
registrations for pharmaceutical products in
agreements, with strategic markets outside
The first tablet resulting from this program, Oralair(R) (grass pollen
immunotherapy tablet), is available in
tablet is currently being evaluated in other European countries.
The dust mite immunotherapy tablet, Actair(R) was the subject of a phase
IIb/III study in allergic rhinitis in adults during the first half of 2009. A
pediatric study has been launched.
Phase IIb/III of the rBet v 1 tablet program has just been completed
The other allergens concerned by the program are ragweed for the North
American market and Japanese cedar pollen for the Japanese market. All
together, the program covers 80% of the epidemiology for all markets.
Biomay has more than two decades of expertise in the expression,
purification and characterization of recombinant allergens. Biomay offers
these allergens off-the-shelf at two quality levels: research-grade and
GMP-grade for the production of therapies
Further information about Biomay is available online at:
ABOUT CMC BIOLOGICS
CMC Biologics is a leading player, in offering integrated services for
development and production of biopharmaceutical products. The Company
specializes in process development and large-scale manufacturing of
pharmaceutical proteins, in compliance with the most stringent cGMP
standards, for use in preclinical studies, clinical trials and large-scale
commercialization. CMC Biologics offers a broad range of services, including
the development of cell lines, development processes, formulations and
analytical tests. CMC Biologics has manufacturing sites in
Further information about CMC Biologics is available online at:
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. A pioneer and leader in sublingual immunotherapy treatments,
Stallergenes devotes 21% 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 2008, Stallergenes had a turnover of
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 ---------------------------------
 Bousquet J. et al. Geographical variation in the prevalence of
positive skin prick tests to environmental aeroallergens in the European
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