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Patent
Stallergenes | Date: 2016-08-18

The invention relates to an immunogenic composition far sublingual, perlingual or oral administration, comprising at least an antigen and at least an adjuvant that is a bacterium selected from a Bifidobacterium and a lactic acid bacterium, and or a combination of a corticosteroid with vitamin D3 or any metabolite or analog of the latter, in a pharmaceutically acceptable carrier that is suitable tor sublingual, perlingual, or oral administration. Such compositions allow to elicit antigen-specific immune tolerance.


The invention relates to grass pollen extracts containing reduced amount of flavonoid glycosides in order to minimize the risks of genotoxicity of the grass pollen extracts. The invention also relates to a method of preparing grass pollen extracts containing reduced amount of flavonoid glycosides by ultrafiltration. Flavonoid glycosides are naturally present in grass pollen extracts and they have been identified as being responsible for the formation of flavonoid aglycones, which are genotoxic in vitro, under the influence of enzymes contained in the grass pollen extracts.


Frati F.,Stallergenes | Incorvaia C.,ICP Hospital | Lombardi C.,SantOrsola Hospital | Senna G.,University of Verona
European Annals of Allergy and Clinical Immunology | Year: 2012

Allergen immunotherapy (AIT) is the only treatment able to act on the causes and not merely on the symptoms of allergy. AIT was introduced 100 years ago but remained an empirical treatment for more than 40 years, when the first controlled trial in 1954 opened the era of scientific evidence. A major advance was the introduction of venom immunotherapy to prevent anaphylaxis from insect stings in 1978. Concerning inhalant allergens, currently AIT may be administered in two forms, subcutaneous (SCIT), and sublingual immunotherapy (SLIT). A large number of trials, globally analyzed in a number of meta-analyses, gave sound evidence to the efficacy and safety of SCIT and SLIT in allergic rhinitis and asthma. Adverse systemic reactions are still a drawback for SCIT, while safety and tolerability of SLIT are very good, provided recommended doses and schedules of administration are used. A significant advance for SLIT development was the registration in Europe of the standardized quality tablets. New applications, such as food allergy and atopic dermatitis, as well as new routes of administration, are currently under evaluation. After 100 years of use, AIT has a central role in the management of allergy and the ongoing improvement seems able to warrant to AIT an even brighter future.


Frati F.,Stallergenes | Dell'Albani I.,Stallergenes | Incorvaia C.,ICP Hospital
Immunotherapy | Year: 2013

Evaluation of: Stelmach I, Sobocinska A, Majak P, Smejda C, Jerzynska J, Stelmach W. Comparison of the long-term efficacy of 3- and 5-year house dust mite allergen immunotherapy. Ann. Allergy Asthma Immunol. 109, 274-278 (2012). Allergen-specific immunotherapy (SIT) is the only treatment of allergic diseases able to maintain its efficacy after discontinuation of treatment. The available literature suggests that a 3-year duration of treatment maintains the efficacy on allergic symptoms for at least an equivalent period of time. The current paper compares the 3- and 5-year duration in children with dust mite-induced asthma, and confirms that 3 years of SIT maintains its effectiveness for a further 3 years after stopping, with no significant difference compared with 5 years. Thus, 3 years is likely to be an adequate duration of SIT; however, studies with more prolonged follow-up periods are needed to investigate the persistence of the clinical benefit over time. © 2013 Future Medicine Ltd.


Baron-Bodo V.,Stallergenes
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology | Year: 2013

During allergen-specific sublingual immunotherapy (SLIT), the relevance of changes in specific IgE and IgG antibody titres to treatment efficacy remains to be evaluated at an individual patient level. To investigate whether antibody responses can be used as biomarkers for SLIT efficacy. Comprehensive quantitative, qualitative and functional analyses of allergen-specific IgA, IgE, IgG1-4 and IgM responses were performed using purified Phl p 1 to 12 allergens in sera, saliva and nasal secretions from 82 grass pollen allergic patients. These patients were enrolled in a randomized, double-blind placebo-controlled study and assessed in an allergen challenge chamber (ClinicalTrials.gov NCT00619827). Antibody responses were monitored in parallel to clinical responses before and after daily sublingual treatment for 4 months with either a grass pollen or a placebo tablet. A significant mean improvement (i.e. 33-40.6%) in rhinoconjunctivitis total symptom scores was observed in SLIT recipients, irrespective of their baseline patterns of IgE sensitization (i.e. narrow, intermediate, broad) to grass pollen allergens. SLIT did not induce any de novo IgE sensitization. Clinical responders encompassed both immunoreactive patients who exhibited strong increases in titres, affinity and/or blocking activity of grass-pollen-specific IgGs (representing 17% of treated patients), as well as patients with no detectable antibody responses distinguishing them from the placebo group. No significant changes were detected in antibody titres in saliva and nasal washes, even in clinical responders. Sublingual immunotherapy with a grass pollen tablet is efficacious irrespective of the patients' baseline sensitization to either single or multiple grass pollen allergens. Seric IgG responses may contribute to SLIT-induced clinical tolerance in a fraction (i.e. 17%) of patients, but additional immune mechanisms are involved in most patients. Consequently, antibody responses cannot be used as a marker of SLIT efficacy at an individual patient level. © 2013 John Wiley & Sons Ltd.


Didier A.,Rangueil Larrey Hospital | Bons B.,Stallergenes
Expert Opinion on Drug Safety | Year: 2015

Introduction: The 5-grass pollen tablet (Oralair®, Stallergenes, Antony, France) is a once-daily preseasonal and coseasonal sublingual immunotherapy (SLIT) that is effective in controlling the symptoms of allergic rhinoconjunctivitis and in reducing the need for symptomatic medication.Areas covered: The body of safety data gathered from the 5-grass pollen tablet clinical development program, post-approval studies, and more than 6 years of real-life experience demonstrates the safety and tolerability profile of the 5-grass pollen tablet across all age groups. Adverse events (AEs) are generally mild or moderate in severity, and rarely lead to treatment discontinuation. AEs also tend to decline in frequency and severity over time and with repeated treatment. The most frequent treatment-emergent AEs are local-site oropharyngeal reactions (e.g., oral pruritus, throat irritation, tongue pruritus, mouth edema, ear pruritus), which are consistent with the sublingual route of administration.Expert opinion: The first dose of the 5-grass pollen tablet should be administered under the supervision of an experienced physician, to allow for optimal monitoring and timely management of AEs, should they occur. The 5-grass pollen tablet can be administered at home after the first dose, and patients and carers should be educated on how to manage adverse reactions, unplanned treatment interruptions and situations in which SLIT should be withheld. © 2015 Informa UK, Ltd.


Zimmer A.,Stallergenes | Bouley J.,Stallergenes | Le Mignon M.,Stallergenes | Pliquet E.,Stallergenes | And 9 more authors.
Journal of Allergy and Clinical Immunology | Year: 2012

Background: Given their pivotal role in the polarization of T-cell responses, molecular changes at the level of dendritic cells (DCs) could represent an early signature indicative of the subsequent orientation of adaptive immune responses during immunotherapy. Objective: We sought to investigate whether markers of effector and regulatory DCs are affected during allergen immunotherapy in relationship with clinical benefit. Methods: Differential gel electrophoresis and label-free mass spectrometry approaches were used to compare whole proteomes from human monocyte-derived DCs differentiated toward either regulatory or effector functions. The expression of those markers was assessed by using quantitative PCR in PBMCs from 79 patients with grass pollen allergy enrolled in a double-blind, placebo-controlled clinical study evaluating the efficacy of sublingual tablets in an allergen exposure chamber over a 4-month period. Results: We identified several markers associated with DC1 and/or DC17 effector DCs, including CD71, FSCN1, IRF4, NMES1, MX1, TRAF1. A substantial phenotypic heterogeneity was observed among various types of tolerogenic DCs, with ANXA1, Complement component 1 (C1Q), CATC, GILZ, F13A, FKBP5, Stabilin-1 (STAB1), and TPP1 molecules established as shared or restricted regulatory DC markers. The expression of 2 of those DCs markers, C1Q and STAB1, was increased in PBMCs from clinical responders in contrast to that seen in nonresponders or placebo-treated patients. Conclusion: C1Q and STAB1 represent candidate biomarkers of early efficacy of allergen immunotherapy as the hallmark of a regulatory innate immune response predictive of clinical tolerance. © 2012 American Academy of Allergy, Asthma & Immunology.


Trademark
Stallergenes | Date: 2016-07-08

Pharmaceutical preparations for the treatment of allergies; medicines in the form of tablets for the treatment of allergies.


Patent
Stallergenes | Date: 2014-07-02

The present invention concerns C1q for use for treating allergy and/or asthma. The invention also relates to a pharmaceutical composition comprising C1q and at least one allergen and to products comprising C1q and at least one allergen as a combined preparation for use for treating allergy and/or asthma.


The present invention concerns allergen extracts, in particular ragweed (Ambrosia) pollen allergen extracts, containing reduced amounts of copper-binding-like proteins in order to minimize the risk of toxicity, including induction of angioedema, of those allergen extracts. The invention also relates to methods of preparing allergen extracts containing reduced amounts of copper-binding-like proteins.

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