Navigation Links
Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber

ANTONY, France, August 27 /PRNewswire-FirstCall/ --

- Oralair(R) Grasses 300IR Highly Positive Clinical Results in a Pharmacodynamic Study Conducted in an Allergen Challenge Chamber

Stallergenes S.A. announces the highly positive results of a new study conducted in an Allergen Challenge Chamber (ACC).

The study on Oralair(R) Grasses included 86 adult patients exposed to grass pollen challenge with different treatment durations: 1 week, 1 month, 2 and 4 months without a titration phase. Use of rescue medication was not allowed.
The outcomes of this trial in line with the objectives were:

- An onset of action starting on the seventh day

(statistically significant at one month)

- An efficacy plateau reached on challenge at the first month

- A highly statistically significant effect of Oralair(R)

Grasses versus placebo (p=0.0003) on the average symptom score (RTSS).

The magnitude of efficacy (34%)1 was similar to the findings of the

Previous studies VO34 (in adults) and VO52 (in a paediatric population)

- A Cohen score of 0.79 corresponding to a large effect size

Safety results, with only well-known local adverse events, and efficacy results were consistent with the findings of Oralair(R) Grasses studies previously conducted in adults (VO34) and children (VO52) in phase III trials.

"This study has demonstrated a clear consistency with the outcomes of previous pivotal studies. It opens the way for ACC as a new tool for phase II studies reducing the unpredictability of pollination. Moreover, it confirms the therapeutic effect of Oralair(R) Grasses and the very fast onset of action on the symptoms," said Olivier de Beaumont.

1 on median scores


This was a randomised, double-blind, parallel-group, placebo-controlled, single centre, phase I study to assess, subsequent to allergen challenge in an allergen exposition chamber, the efficacy and time course of sublingual immunotherapy (SLIT) administered as 300IR allergen-based tablets once daily to 86 adults suffering from grass pollen rhinoconjunctivitis. The main objectives of the study were to assess the efficacy of grass pollen extract SLIT tablets compared to placebo on the average Rhinoconjunctivitis Total Symptom Score (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes), to evaluate the onset of action after different treatment durations (1 week, 1 month, 2 and 4 months) through the challenge test, to identify immunological parameters as possible biomarkers for SLIT, and to assess safety. Since patients were not allowed to take any rescue medication, the symptom score was not impacted by its usage and the difference between the placebo and active group was due exclusively to the effect of the Oralair(R) Grasses tablet.


The Allergen Challenge Chamber is already recognized as a supportive study by the FDA and the European Medicines Agency (EMEA). The interest of ACC as an assessment tool for clinical development is confirmed. The Allergen Challenge Chamber (ACC) offsets the unpredictability of the pollen season, and thereby avoids the variable nature of pollens and patient exposure and facilitates follow up.

About oralair(R) Grasses

Oralair(R) Grasses is a fast-dissolving tablet that has demonstrated high efficacy in treating allergic rhinoconjunctivitis to grass pollen starting with the first season, lasting throughout the pollen season, and at the pollen peak, on:

- Poly- and mono-sensitised patients, as well as asthmatic


- Every individual symptom, and in particular on nasal

congestion and watery eyes.

Oralair(R) Grasses is a pre-seasonal treatment: it has to be started four months before the pollen season, be maintained throughout the season, and then stopped and restarted the following season.

Oralair(R) Grasses contains a mix of 5 standardised grass allergens: perennial rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum), as a daily dose of 300 IR, so as to mimic patients' natural exposure.

In June 2008, Stallergenes was granted a marketing authorisation for Oralair(R) Grasses in adults, by PEI (Paul Ehrlich Institute), the biological branch of the German health agency.

Based on the positive results of the paediatric pivotal study (VO52), Stallergenes has applied in July 2008 for the paediatric extension of the product's indications.

The clinical development programme has already enrolled around 1600 patients to date. A long term pivotal study is proceeding according to schedule, and is currently in its second year. The company plans to file two INDs for adult and paediatric trials with the FDA this year.

About Stallergenes

Stallergenes is a European biopharmaceutical company dedicated to desensitisation therapies for the prevention and treatment of allergy-related respiratory diseases, e.g. rhinoconjunctivitis and allergic asthma. A pioneer and leader in sublingual desensitisation treatments, Stallergenes devotes 16% of its turnover to Research and Development and is actively involved in the development of a new therapeutic class: sublingual desensitisation tablets.

In 2007, Stallergenes had a turnover of 147 million euros and provided desensitisation treatments to more than 500,000 patients.

Stallergenes is listed on Euronext Paris (Compartment B) and is part of the sample composing the SBF 120 index.
ISIN Code: FR0000065674

Reuters Code: GEN.PA

Bloomberg Code: GEN.FP

Additional information is available at

SOURCE Stallergenes
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing
2. Head-to-Head Study Showed Prasugrel Statistically Superior to Clopidogrel in Reducing Recurrent Cardiovascular Events
3. Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
4. BioVex Announces Regulatory Clearance to Commence a Clinical Study With ImmunoVEX HSV2; A Vaccine Candidate for Genital Herpes
5. febit and TGen Collaborate to Study New DNA Capture Method
6. Study Shows Benefits of a High Omega-3 Diet in Older Adults
7. NewCardio Announces Positive Results From Third Clinical Validation Study
8. M. D. Anderson to Initiate Clinical Validation Study on Rosetta Genomics MicroRNA-based Diagnostic Assay Identifying the Origin of Cancer Metastases
9. Emisphere Announces Recruitment of Novartis Phase III Study for Oral Osteoporosis Treatment
10. Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
11. Icon Bioscience Completes Enrollment in Phase I Study of Novel Ophthalmic Drug Candidate
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015  Enova Illumination is pleased to ... Helsinki, Finland to combine their world ... the cutting edge of medical visualization: Enova is the ... the United States and Novocam is the ... provide the world,s most powerful battery-operated LED headlight with ...
(Date:11/24/2015)... Nov. 24, 2015 Abaxis, Inc. (NasdaqGS: ... and consumables for the medical, research, and veterinary markets ... Financial Officer, will present at the 27 th ... 2015 at 11:30 a.m. ET. The conference will be ... New York City . Abaxis, ...
(Date:11/24/2015)...   Mast Therapeutics, Inc. (NYSE MKT: MSTX), ... sealant technology (MAST) platform to develop novel therapies for ... that the Company,s Chief Executive Officer, Brian M. ... th Annual Healthcare Conference on Tuesday, December 1, ... Palace hotel in New York City ...
Breaking Medicine Technology:
(Date:11/24/2015)... CA (PRWEB) , ... November 24, 2015 , ... ... sizes, has launched their Black Friday sale a week early, offering 40% off ... to transform the intimate apparel industry through both mobile fit technology and the ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Preparing for the ... – 3:00 p.m. EST, , FDA has long asserted that design ... apply to performing the tests and do not meet the device regulations. , Come ...
(Date:11/24/2015)... ... November 24, 2015 , ... United Benefit Advisors (UBA), ... & Company as its newest Partner Firm. Based in Jefferson City, Missouri, their ... trusted advisor regardless of whether that client is a business, a family, or ...
(Date:11/24/2015)... ... 2015 , ... With Thanksgiving right around the corner, holiday travel season is ... your family and vehicle. , According to the National Highway Traffic Safety Administration, 301 ... sharing the following safety tips from the NHTSA: , ...
(Date:11/24/2015)... ... November 24, 2015 , ... Dr. Rodney E. Willey , has answered a ... Koala Center for Sleep Disorders, provides treatment for snoring and sleep apnea through ... a Koala Center for Sleep Disorders in the US, one of four in the Illinois ...
Breaking Medicine News(10 mins):