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Claims for Patent: 6,555,554

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Claims 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)
Application Number:09/781,179
Patent 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.
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