Cyclooxygenase-2 inhibitor/histone deacetylase inhibitor combination

Abstract

The invention relates to a combination which comprises (a) a cyclooxygenase-2 inhibitor (“COX-2 inhibitor”) and (b) a histone deacetylase inhibitor (“HDAI”) for simultaneous, concurrent, separate or sequential use, especially for use in the treatment of pre-malignant colon lesions or a colon cancer or other malignancies in a mammal, particularly a human. The invention also relates to pharmaceutical compositions comprising such a combination and to a method of treating pre-malignant colon lesions (e.g. polyps) and colon cancer, as well as other malignancies, in a mammal, particularly a human, with such a combination. The present invention further also relates to a commercial package or product comprising such a combination.

1 - 33 . (canceled) 
     
     
         34 . A commercial package or product comprising (a) 5-methyl-2-(2′-chloro-6′-fluoro-anilino)-phenyl acetic acid, or a pharmaceutically acceptable salt thereof, and (b) N-hydroxy-3-[4-[[(2-hydroxyethyl)[2-(1H-indol-3-yl)ethyl]-amino]methyl]phenyl]-2E-2-propenamide or a pharmaceutically acceptable salt thereof, together with instructions for simultaneous, concurrent, separate or sequential use thereof in the treatment of a disease in a mammal. 
     
     
         35 . (canceled) 
     
     
         36 . A commercial package or product comprising a COX-2 inhibitor or a pharmaceutically acceptable salt thereof, together with instructions for use in combination with a histone deacetylase inhibitor, or a pharmaceutically acceptable salt thereof, for the treatment of a disease in a mammal, or
 a commercial package or product comprising a histone deacetylase inhibitor, or a pharmaceutically acceptable salt thereof, together with instructions for use in combination with a COX-2 inhibitor, or a pharmaceutically acceptable salt thereof, for the treatment of a disease in a mammal.   
     
     
         37 . (canceled) 
     
     
         38 . The commercial package or product of  claim 34  comprising instructions for use in the treatment of pre-malignant colon lesions or a colon cancer or other malignancies in a mammal. 
     
     
         39 - 44 . (canceled) 
     
     
         45 . The commercial package or product of  claim 38  where said other malignancies are selected from the group consisting of breast cancer, lung cancer, ovarian cancer, lymphoma, head and neck cancer and cancer of the esophagus, stomach, bladder, prostrate, uterus and cervix. 
     
     
         46 . The commercial package or product of  claim 36  comprising instructions for use in the treatment of pre-malignant colon lesions or a colon cancer or other malignancies in a mammal. 
     
     
         47 . The commercial package or product of  claim 46  where said other malignancies are selected from the group consisting of breast cancer, lung cancer, ovarian cancer, lymphoma, head and neck cancer and cancer of the esophagus, stomach, bladder, prostrate, uterus and cervix.