Details for Patent: 6,555,554

Title:	Isoindolines, method of use, and pharmaceutical compositions
Abstract:	Substituted 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines are useful in reducing undesirable levels of TNF.alpha. in a mammal. Typical embodiments are pharmaceutical compositions containing 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline and 1-oxo-2-(2,6-dioxo-3-methylpiperidin-3-yl)-4-aminoisoindoline.
Inventor(s):	Muller; George W. (Bridgewater, NJ), Stirling; David I. (Branchburg, NJ), Chen; Roger Shen-Chu (Edison, NJ)
Assignee:	Celgene Corporation (Warren, NJ)
Filing Date:	Feb 12, 2001
Application Number:	09/781,179
Claims:	1. A pharmaceutical composition comprising, in combination with a pharmaceutically and physiologically suitable carrier, a compound of the formula: ##STR7## or a physiologically acceptable non-toxic acid addition salt thereof, in a quantity sufficient upon administration in a single or multiple dose regimen to a mammal to produce at least one of the effects of reducing the level of TNF.alpha., improving an oncogenic or cancerous condition, reducing inflammation, or improving autoimmune disease. 2. A pharmaceutical composition according to claim 1 in which said compound has the R-configuration. 3. A pharmaceutical composition according to claim 1 in which said compound has the S-configuration. 4. A pharmaceutical composition according to claim 1 containing from 1 to 100 mg. of said compound. 5. The pharmaceutical composition according to claim 1 in which said dosage form is a powder, tablet, or capsule. 6. The pharmaceutical composition according to claim 1 in which said dosage form is an injectable composition. 7. The pharmaceutical composition according to claim 1 which is administered in combination with a therapeutic agent. 8. The pharmaceutical composition according to claim 1 wherein said therapeutic agent is a steroid, neoplastic agent or antibiotic. 9. The pharmaceutical composition according to claim 5 wherein said composition contains from 1 to 100 mg. of said compound and is in a form suitable for administration in a single or multiple dosage regimen. 10. A method of reducing undesirable levels of TNF.alpha. in a mammal which comprises administering thereto an effective amount of a compound of the formula: ##STR8## or a physiologically acceptable non-toxic acid addition salt thereof, in which R.sup.6 is hydrogen or methyl. 11. The method according to claim 10 in which said compound has the formula: ##STR9## 12. The method according to claim 11 wherein said compound is administered orally or parenterally. 13. The method according to claim 11 in which said compound is administered in combination with a therapeutic agent. 14. The method according to claim 11 in which said compound has the R-configuration. 15. The method according to claim 11 in which said compound has the S-configuration. 16. The method according to claim 11 in which said compound is administered in a single or multiple dosage regimen as a pharmaceutical composition containing from 1 to 100 mg. of said compound. 17. The method according to claim 11 in which said compound is administered in the form of a physiologically acceptable non-toxic acid addition salt.