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Last updated on April 23, 2014 at 21:24 EDT

Stallergenes: Positive Results for Oralair(R) Phase III Trial in the USA

April 19, 2010

ANTONY, France, April 19, 2010 /PRNewswire-FirstCall/ — Stallergenes
S.A. today announced the first results of a phase III clinical trial
(VO61.08) conducted in the USA on its sublingual grass pollen immunotherapy
tablet, Oralair(R).

This phase III study is the first clinical study in the USA to be
conducted by Stallergenes as part of the Oralair(R) clinical development
which already encompassed 4 phase III clinical trials conducted in Europe.
This development program has so far included over 2,300 patients. This study
is pivotal in the perspective of a market authorization application for
Oralair(R) in the USA with an adult indication (BLA[1]).

The VO61.08 study is a randomized, double-blind, placebo-controlled,
phase III trial. It included 473 adult patients, aged 18 to 65 years,
suffering from grass pollen-induced rhinoconjunctivitis, in 51 centers in the
United States
. The patients were divided into two arms: one group was treated
with Oralair(R) and the other with a placebo. The primary endpoint was the
reduction of the “combined score”, taking into account symptoms and rescue
drugs.

The study achieved its objective on the primary endpoint: the reduction
of the combined score obtained by Oralair(R) compared to the placebo is
statistically very significant and of a similar magnitude to the results of
European studies. The product was very well tolerated.

“We are proud to have conducted this study in the USA and very satisfied
with the results obtained which confirm the high level of evidence in support
of Oralair(R)” commented Albert Saporta, Chairman and CEO of Stallergenes.
“We have passed an important milestone in our strategy for the US market and
are actively preparing the registration file with a view to filing a Market
Authorization application in early 2011.”

About Oralair(R)

The Oralair(R) active substance consists of five purified and calibrated
pollen extracts corresponding to the epidemiological characteristics of
patient exposure in Europe: perennial rye grass (Lolium perenne), meadow
grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis
glomerata) and sweet vernal grass (Anthoxanthum odoratum).

From the outset, its clinical development has taken into account the
benefit to patients: proven efficacy, safety, ease of use, compliance, and
cost-containment through a pre- and coseasonal protocol (the treatment is
taken for four months prior to the pollen season and then throughout it, for
three consecutive seasons) rather than a perennial protocol.

The clinical development program for Oralair(R) is continuing.
Stallergenes has recently announced the positive 3-year results of a phase
III clinical trial (VO53.06) intended to assess the long-term or sustained
effect of Oralair(R) along with maintenance of the therapeutic benefit after
treatment discontinuation (disease-modifier effect). This study is the first
ever pivotal study designed to measure this dual effect from the outset. It
will continue for 2 years without treatment so that the disease-modifier
effect can be fully assessed.

About the Stalair(R) Program

Stalair(R) is 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.

A positive phase IIb/III study was completed for the dust mite
immunotherapy tablet, Actair(R) in allergic rhinitis in adults during the
first half of 2009. A pediatric phase III study has been launched.

The Bet v 1 tablet (birch pollen recombinant) 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 for the North
American market and Japanese cedar pollen for the Japanese market.
Altogether, the program covers 80% of the epidemiology for all markets.

About Stallergenes

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 over 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, the company had a turnover of 193
million euros
and more than 500,000 patients were treated with Stallergenes
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] BLA: Biologics License Application

SOURCE Stallergenes


Source: newswire