US2003195260A1PendingUtilityA1

Methods and pharmaceutical compositions employing S(+)-desmethylselegiline to treat neoplastic diseases or conditions

Priority: Jan 13, 1995Filed: Jan 28, 2003Published: Oct 16, 2003
Est. expiryJan 13, 2015(expired)· nominal 20-yr term from priority
Inventors:Anthony Disanto
C07C 211/27A61K 31/135A61K 31/137A61K 45/06Y02A50/30
50
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Claims

Abstract

The application is directed to the treatment of neoplastic diseases or conditions by administering R(−) desmethylselegiline, S(+) desmethylselegiline, or a combination of the two. Neoplastic diseases and conditions responsive to R(−) desmethylselegiline and/or S(+) desmethylselegiline include both malignant and benign neoplasms.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A method for obtaining a selegiline therapeutic effect in a patient with a neoplastic disease or condition, comprising administering to the patient R(−)DMS in a dosage regimen effective to inhibit, in whole or in part, occurrence or progression of the neoplastic disease or condition.  
     
     
         2 . The method of  claim 1 , wherein the R(−)DMS is in a substantially enantiomerically pure form.  
     
     
         3 . The method of  claim 1 , wherein the R(−)DMS is administered as the free base.  
     
     
         4 . The method of  claim 1 , wherein the R(−)DMS is administered as an acid addition salt.  
     
     
         5 . The method of  claim 4 , wherein the acid addition salt is hydrochloride salt.  
     
     
         6 . The method of  claim 1 , wherein the neoplastic disease or condition is a mammary tumor or a pituitary tumor.  
     
     
         7 . The method of  claim 1 , wherein the R(−)DMS is administered at a daily dose of between about 0.02 mg/kg and about 5.0 mg/kg, calculated on the basis of the free secondary amine.  
     
     
         8 . The method of  claim 1 , wherein the R(−)DMS is administered at a daily dose of between about 0.6 mg/kg and about 0.8 mg/kg, calculated on the basis of the free secondary amine.  
     
     
         9 . The method of  claim 1 , wherein the R(−)DMS is administered by an oral route of administration.  
     
     
         10 . The method of  claim 1 , wherein the R(−)DMS is administered by a non-oral route of administration.  
     
     
         11 . The method of  claim 1 , wherein the R(−)DMS is administered sublingually, buccally, or parenterally.  
     
     
         12 . The method of  claim 1 , wherein the R(−)DMS is administered by a transdermal patch.  
     
     
         13 . The method of  claim 1 , wherein the patient is a human.  
     
     
         14 . A pharmaceutical composition, comprising: 
 a) R(−)DMS; and    b) a second therapeutic agent useful in the treatment of a neoplastic disease or condition.    
     
     
         15 . The composition of  claim 14 , wherein the second therapeutic agent is an anti-neoplastic agent.  
     
     
         16 . The composition of  claim 15 , wherein the anti-neoplastic agent is tamoxifen, cisplatin, paclitaxel, or methotrexate.  
     
     
         17 . The composition of  claim 14 , wherein the second therapeutic agent is a radiation implant.  
     
     
         18 . The composition of  claim 14 , wherein between about 0.02 and about 5.0 mg/kg of R(−)DMS, calculated on the basis of the free secondary amine, is in a unit dose of the composition.  
     
     
         19 . The composition of  claim 14 , wherein between about 0.6 and about 0.8 mg/kg of R(−)DMS, calculated on the basis of the free secondary amine, is in a unit dose of the composition.  
     
     
         20 . The composition of  claim 14 , wherein between about 1.0 mg and about 100.0 mg of R(−)DMS is in a unit dose of the composition.  
     
     
         21 . The composition of  claim 14 , wherein between about 5.0 mg and about 10.0 mg of R(−)DMS is in a unit dose of the composition.  
     
     
         22 . The composition of  claim 14 , for oral administration.  
     
     
         23 . The composition of  claim 14 , for non-oral administration.  
     
     
         24 . The composition of  claim 14 , for transdermal administration.  
     
     
         25 . The composition of  claim 14 , wherein the composition is a transdermal patch.  
     
     
         26 . A method for obtaining a selegiline therapeutic effect in a patient with a neoplastic disease or condition, comprising administering to the patient a pharmaceutical composition comprising: 
 a) R(−)DMS; and    b) a second therapeutic agent useful in the treatment of a neoplastic disease or condition;    wherein one or more unit doses of the composition are effective to inhibit, in whole or in part, occurrence or progression of the neoplastic disease or condition.    
     
     
         27 . A method for obtaining a selegiline therapeutic effect in a patient with a neoplastic disease or condition, comprising administering to the patient S(+)DMS in a dosage regimen effective to s inhibit, in whole or in part, occurrence or progression of the neoplastic disease or condition.  
     
     
         28 . A pharmaceutical composition, comprising: 
 a) S(+)DMS; and    b) a second therapeutic agent useful in the treatment of a neoplastic disease or condition.    
     
     
         29 . A method for obtaining a selegiline therapeutic effect in a patient with a neoplastic disease or condition, comprising administering to the patient a mixture of R(−)DMS and S(+)DMS in a dosage regimen effective to inhibit, in whole or in part, occurrence or progression of the neoplastic disease or condition.  
     
     
         30 . A pharmaceutical composition, comprising: 
 a) a mixture of R(−)DMS and S(+)DMS; and    b) a second therapeutic agent useful in the treatment of a neoplastic disease or condition.

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