Claims for Patent: 7,842,691

Summary for Patent: 7,842,691

Title:	Method for the treatment of myelodysplastic syndromes using cyclopropanecarboxylic acid {2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-3-OXO-2,3-dihy- dro-1 H-isoindol-4-yl}-amide
Abstract:	Methods of treating, preventing and/or managing a myelodysplastic syndrome are disclosed. Specific methods encompass the administration of a selective cytokine inhibitory drug, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with a second active ingredient, and/or blood or cells for transplantation therapy. Specific second active ingredients are capable of affecting or improving blood cell production. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.
Inventor(s):	Zeldis; Jerome B. (Princeton, NJ)
Assignee:	Celgene Corporation (Summit, NJ)
Application Number:	10/531,552
Patent Claims:	1. A method of treating a myelodysplastic syndrome, which comprises administering to a patient having myelodysplastic syndrome a therapeutically effective amount of cyclopropanecarboxylic acid {2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-3-oxo-2,3-dihy- dro-1 H-isoindol-4-yl}-amide, or a pharmaceutically acceptable salt or stereoisomer thereof. 2. The method of claim 1 further comprising a therapeutically effective amount of at least one second active ingredient. 3. The method of claim 2, wherein the second active ingredient is capable of improving blood cell production. 4. The method of claim 2, wherein the second active ingredient is a cytokine, hematopoietic growth factor, anti-cancer agent, antibiotic, proteasome inhibitor, or immunosuppressive agent. 5. The method of claim 2, wherein the second active ingredient is etanercept, imatinib, anti-TNF-.alpha. antibodies, infliximab, G-CSF, GM-CSF, EPO, topotecan, pentoxifylline, ciprofloxacin, irinotecan, vinblastine, dexamethasone, IL2, IL8, IL18, Ara-C, vinorelbine, isotretinoin, 13-cis-retinoic acid, or a pharmacologically active mutant or derivative thereof. 6. The method of claim 1 or 2, wherein the myelodysplastic syndrome is refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or chronic myelomonocytic leukemia. 7. The method of claim 1 or 2, wherein the myelodysplastic syndrome is primary or secondary. 8. The method of claim 1 or 2, wherein the stereoisomer of cyclopropanecarboxylic acid {2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-3-oxo-2,3-dihy- dro-1H-isoindol-4-yl}-amide is S enantiomer. 9. The method of claim 1 or 2 wherein the stereoisomer of cyclopropanecarboxylic acid {2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-3-oxo-2,3-dihy- dro-1H-isoindol-4-yl}-amide is R enantiomer. 10. The method of claim 1, wherein the compound or a pharmaceutically acceptable salt or stereoisomer thereof is administered before, during or after transplanting umbilical cord blood, placental blood, peripheral blood stem cell, hematopoietic stem cell preparation or bone marrow in the patient. 11. The method of claim 2, wherein the second active ingredient is dexamethasone. 12. The method of claim 1, wherein the patient has not been previously treated for a myelodysplastic syndrome. 13. The method of claim 1, wherein the patient has been previously treated for a myelodysplastic syndrome. 14. The method of claim 1, wherein the compound or a pharmaceutically acceptable salt or stereoisomer thereof is administered orally. 15. The method of claim 1, wherein the compound or a pharmaceutically acceptable salt or stereoisomer thereof is administered in the form of a capsule or tablet. 16. The method of claim 1, wherein the compound or a pharmaceutically acceptable salt or stereoisomer thereof is administered cyclically. 17. The method of claim 16, wherein the compound or a pharmaceutically acceptable salt or stereoisomer thereof is administered on days 1-21 every 28 days. 18. The method of claim 16, wherein one cycle comprises the administration of the compound and at least one, two, or three weeks of rest. 19. The method of claim 18, wherein the number of cycles is from one to twelve cycles. 20. The method of claim 16, wherein the compound or a pharmaceutically acceptable salt or stereoisomer thereof is administered in an amount of from about 10 mg to about 2500 mg per day on days 1-21 every 28 days. 21. The method of claim 20, wherein the compound or a pharmaceutically acceptable salt or stereoisomer thereof is administered in an amount of from about 100 mg to about 800 mg per day on days 1-21 every 28 days.

Details for Patent 7,842,691

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2039-02-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2039-02-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2039-02-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2039-02-26
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2039-02-26