Asthma/Allergy Therapy that Targets T-lymphoctyes and/or Eosinophils

Abstract

A pharmaceutical composition for the treatment and/or prophylaxis of diseases caused by type I hypersensitivity reactions consisting essentially of Glicophosphopeptical, or pure Nigella Sativa seeds, in a concentration which stimulate Th1 lymphocytes and selectively switch-off the eosinophilic airway inflammation A method of treatment of allergy using Th1 stimulating agents, to be administered to a mammal such as human in need of such treatment in a shot of 5 days only, resulted in significant decrease in symptom score started day 3, and in sputum eosinophils by day 14, followed by long-term clinical remission of a mean of 6 months. The BCG-like Th1 stimulation is also used in treating diseases in which the body defensive mechanism is a Cell Mediated Immunity, including viral infections, as but not limited to influenza and common cold, Chronic and recurrent urinary tract infection, pelvic inflammatory diseases as neuroimmune appendicitis, cancer, crohns disease and facial palsy.

1 . Use of glycophosphopeptical for the treatment and/or prophylaxis of allergy/asthma for administration to a mammal such as a human in need of such treatment. 
     
     
         2 . Use of glycophosphopeptical for the preparation of an asthma/allergy drug, such as extrinsic, intrinsic or mixed asthma, allergic and perennial rhinitis, allergic conjunctivitis, chronic urticaria, atopic dermatitis, and/or laryngeal oedema, to be administered to a mammal such as human in need of such treatment. 
     
     
         3 . A Pharmaceutical composition comprises glycophosphopeptical, in any pharmacologically active form at a concentration of the extract which is effective as a Th1 stimulating agent. 
     
     
         4 . A Pharmaceutical composition as claimed in  claim 3  further comprising an excipient. 
     
     
         5 . A method of treatment of diseases caused by type I IgE-mediated hypersensitivity reaction comprising the administration to a mammal such as a human in need of such treatment, of an effective dose of glycophosphopeptical. 
     
     
         6 . The  claim 4  including a dosage regimen as a characterizing feature, administering to a patient suffering from a chronic disease a short-term therapy of 5-20 days, preferably 5 days, of a Th1 stimulating agent, to get a long-term clinical remission of months as a result of selective switching-off of the eosinophilic inflammation. 
     
     
         7 . The use of the pure seeds of Nigella sativa for the preparation of an asthma and allergy agent in a concentration which was found to perform substantially the same function in substantially the same way to obtain substantially the same results as with glycophosphopeptical. 
     
     
         8 . A Pharmaceutical composition as claimed in  claim 6  further comprising an excipient. 
     
     
         9 . A medicament as claimed in any preceding claim, which is adapted and/or packaged for periodic administration to said mammal in doses over a period of 5-20 days, preferably 5 days in doses at least once daily up to ten times/day. 
     
     
         10 . A medicament as claimed in  claim 9 , characterized in that each one of said doses comprises up to 2000 mgs of said active agent, preferably about 200-1000 mgs, of said active agent, adapted for oral administration to said mammal in capsules, or tablets, or lozenges, or as a powder, or a suspension, or a syrup 
     
     
         11 . A medicament as claimed in any of  claims 2 ,  3 , and  7 , which is adapted for topical administration to said mammal such as a human, in the form of eye or nasal drops or ointment, also skin or vaginal cream or ointment. 
     
     
         12 . A kit comprising a medicament as claimed in  claim 10  and  11  packaged in separate doses for periodic administration to said mammal such as a human, contains written or printed instructions. 
     
     
         13 . The method of  claim 5  and  7  is dependent on the fact that interferon is an in vivo Eosinophilic Chemotactic Factor, and that serum interferon and Th1 lymphocytes are controlling the pre-inflammatory phase of allergic reaction. 
     
     
         14 . The manufacture of a diagnostic kit to diagnose allergy and asthma and to assess the severity Of the disease, using of a quantitative serum interferon concentration measurement. 
     
     
         15 . The method of  claim 5  and  7  wherein the recommended dose of Th1 lymphocytes stimulating agent is sufficient to selectively switch-off the eosinophilic inflammation in the patient's airway. 
     
     
         16 . The method of  claim 5  and  6  wherein Th1 lymphocytes stimulating agents, are capable of stimulating T lymphocytes in culture, comparable to Purified Protein Derivative of BCG, as a classical Cell Mediated Immunity stimulating agent. 
     
     
         17 . Use of Th1 stimulating agents for the preparation of an agent for the treatment and/or prophylaxis of diseases characterized by a body immune defensive mechanism is Cell Mediated Immunity as viral respiratory tract infections such as, but not limited to influenza and common cold, other viral infections. 
     
     
         18 . A method of treatment of viral respiratory tract infections such as, but not limited to influenza and common cold, other viral infections comprising the administration to a mammal such as a human in need of such treatment, of an effective dose of Th1 stimulating agents. 
     
     
         19 . Use of Th1 stimulating agents for the preparation of an agent, for the treatment and/or prophylaxis of diseases characterized by a body immune defensive mechanism is Cell Mediated Immunity as acute and recurrent urinary tract infection, pelvic inflammatory diseases such as but not limited to neuroimmune appendicitis, and cancer. 
     
     
         20 . A method of treatment of as acute and recurrent urinary tract infection, pelvic inflammatory diseases such as but not limited to neuroimmune appendicitis, and cancer comprising the administration to a mammal such as a human in need of such treatment, of an effective dose of Th1 stimulating agents. 
     
     
         21 . A method of treatment of crohns disease comprising the administration to a mammal such as a human in need of such treatment, of an effective dose of Th1 stimulating agents in order to stimulate Cell Mediated Immunity. 
     
     
         22 . Use of Th1 stimulating agent, for the treatment of crohns disease to be administered to a mammal such as a human in need of such treatment. 
     
     
         23 . A method of treatment of facial palsy comprising the administration to a mammal such as a human in need of such treatment, of an effective dose of Th1 stimulating agents. 
     
     
         24 . Use of Th1 stimulating agent, for the treatment of facial palsy to be administered to a mammal such as a human in need of such therapy.