Methods and treatment for allergies and inflammation associated with gastrointestinal diseases

Inactive Publication Date: 2011-08-25
MASTCELL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010]There needs to be improved methods of preventing unintended development of new sensitization to allergen, as well as treating a

Problems solved by technology

Use of antacids to treat heart burn, for example, may promote the development of new allergy and delay the initiation of therapy appropriate for the underlying disease e.g., eosinophilic esophagitis.
Much data supporting pathogenic implications of IgE-mediated allergies for eosinphilic esophagitis has been demonstrated, but data f

Method used

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  • Methods and treatment for allergies and inflammation associated with gastrointestinal diseases
  • Methods and treatment for allergies and inflammation associated with gastrointestinal diseases
  • Methods and treatment for allergies and inflammation associated with gastrointestinal diseases

Examples

Experimental program
Comparison scheme
Effect test

example 1

Use of Ketotifen as a Prophylaxis in Patients at Risk of Sensitization to Hazelnut Allergen

[0783]Twenty-four patients with adverse food reaction are included in this study. As controls, twelve patients matched for age and gender and a history of GERD (Group A) and another twelve patients matched for age and gender and no history of any gastrointestinal disorder (Group B) are included. The history of use of antacids and satisfaction are recorded for both groups.

[0784]To analyze hypersensitivity to hazelnut, a double-blind, randomized, dose-ranging study is carried out with patients with a history of hazelnut allergy manifested by urticaria, angioedema, respiratory tract symptoms or hypotension generally using the methods described in Israel et al., Am. J. Respir. Crit. Care Med., (2000) 164:75-80. Eligible patients include those with serum total IgE level of 30-1000 IU / mL and / or a positive skin-prick test to hazelnut. Patients must have asthma condition under control with a forced ex...

example 2

Use of Ketotifen During Desensitization to Airborne Allergen

[0790]To evaluate the effectiveness of mast cell stabilizer, e.g., ketotifen, in desensitization or immunotherapy, particularly RUSH immunotherapy, a randomized, double-blind, placebo-controlled study is performed. Patients are randomly assigned to 4 treatment groups (1:1:1:1). Pretreatment with either ketotifen, 1 mg, b.i.d., or placebo, is carried out for nine weeks to protect, prevent, inhibit or ameliorate allergic reaction, particularly to prevent, normalize or ameliorate gastrointestinal symptoms. One-day rush immunotherapy (week 0) is completed at least 3 weeks before the start of the ragweed season. On the day of rush immunotherapy, the patients receive 6 injections of either placebo or aqueous short ragweed extract. Ragweed dosing starts with a diluted extract containing 0.012 μg of Amb a 1 (a major allergen in ragweed) over a 3-hour period, reaching a maximum of 1.2 μg of Amb a 1. Some subjects also receive 2 addi...

example 3

Use of Ketotifen During Desensitization to Oral Allergen

[0793]To evaluate the efficacy of ketotifen in desensitization process against oral allergen such as hazelnut, a similar study as described in Example 3 may be carried out except with the use of hazelnut extract rather than ragweed extract. The studies will show that patients who receive ketotifen plus immunotherapy have fewer adverse events of gastrointestinal disorders and significantly improved allergy severity scores compared to those receiving immunotherapy alone.

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Abstract

Methods of the prophylaxis of the development of allergy in a patient at risk of sensitization to an antigen(s) or allergen(s) due to impaired gastrointestinal functions include administering a mast cell inhibitor, e.g., ketotifen, e.g., ketotifen fumarate. Methods for prophylactically treating, reducing, delaying or controlling gastrointestinal disorders include administering a mast cell stabilizer, e.g., ketotifen to a patient in need thereof. Pharmaceutical preparation, composition for use in methods described, are also disclosed. Also disclosed are methods of prophylaxis or treating gastrointestinal and esophageal inflammation, and methods for the prophylaxis of the development of additional allergies to a newly introduced substance in a patient with a preexisting allergy. Such methods include delivery of a mast cell stabilizer, e.g., ketotifen. Oral and topical administration are contemplated within the scope of the methods.

Description

REFERENCE TO RELATED APPLICATIONS [0001]This application claims the benefit of PCT / US2009 / 003191, filed on May 22, 2009, and U.S. Provisional Application Ser. No. 61 / 055,964, filed May 23, 2008, the disclosure of each of which is hereby incorporated by reference in their entirety.FIELD OF THE INVENTION [0002]The present invention relates to methods for the prophylaxis of the development of allergy in a patient at risk of sensitization to an antigen(s) or allergen(s) due to impaired gastrointestinal functions comprising administering a mast cell inhibitor, e.g., ketotifen, e.g., ketotifen fumarate. The invention also provides methods for prophylactically treating, reducing, delaying or controlling symptoms of and inflammation associated with gastrointestinal disorders, e.g., due to exposure to allergen due to desensitization therapy and / or due to impaired gastrointestinal functions such as impaired gastrointestinal digestion and / or increased intestinal permeability, comprising admini...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K31/4535A61K31/60A61P37/08
CPCA61K31/381A61K31/445A61K39/35A61K45/06A61K39/0008A61K31/4535A61K2300/00A61P1/04A61P1/12A61P29/00A61P37/08
Inventor PENN, DENNIS
Owner MASTCELL PHARMA
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