Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2004-11-15
2009-11-24
Lewis, Patrick T (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S043000, C514S049000
Reexamination Certificate
active
07622458
ABSTRACT:
Methods of treating a human body for cancer are provided. In one aspect, a therapeutic amount of capecitabine is administered in combination with ET-743 in a dose range between 0.75 and 1.4 mg/m2for Et-743. In a related aspect, an effective therapeutic amount of ET-743 is administered in combination with capecitabine in a dose range between 1500 to 2500 mg/m/day for capecitabine.
REFERENCES:
patent: 5089273 (1992-02-01), Rinehart et al.
patent: 5149804 (1992-09-01), Rinehart et al.
patent: 5256663 (1993-10-01), Rinehart et al.
patent: 5472949 (1995-12-01), Arasaki et al.
patent: 5478932 (1995-12-01), Rinehart et al.
patent: 5552544 (1996-09-01), Fernandez et al.
patent: 5654426 (1997-08-01), Rinehart et al.
patent: 5721362 (1998-02-01), Corey et al.
patent: 5908835 (1999-06-01), Bissery
patent: 5985876 (1999-11-01), Rinehart et al.
patent: 6124293 (2000-09-01), Rinehart et al.
patent: 6153590 (2000-11-01), Andersen et al.
patent: 7241892 (2007-07-01), Cuevas et al.
patent: 2002/0137663 (2002-09-01), Forman et al.
patent: 2004/0002602 (2004-01-01), Francesch et al.
patent: 2004/0019027 (2004-01-01), Forman et al.
patent: 2004/0108086 (2004-06-01), Takahashi et al.
patent: 2006/0030571 (2006-02-01), Rinehart
patent: 2006/0094687 (2006-05-01), Beijnen
patent: 2007/0004691 (2007-01-01), Donald
patent: 2007/0082856 (2007-04-01), Gianni
patent: 2007/0128201 (2007-06-01), D'Incalci et al.
patent: WO 99/51238 (1999-10-01), None
patent: WO 99/58125 (1999-11-01), None
patent: WO 00/69441 (2000-11-01), None
patent: WO 00/69862 (2000-11-01), None
patent: WO 01/77115 (2001-10-01), None
patent: WO 01/87894 (2001-11-01), None
patent: WO 02/36135 (2002-05-01), None
patent: WO 02/064843 (2002-08-01), None
patent: WO 03/020259 (2003-03-01), None
patent: WO 03/039571 (2003-05-01), None
patent: WO 2005/049029 (2005-06-01), None
patent: WO 2005/049030 (2005-06-01), None
patent: WO 2005/049031 (2005-06-01), None
patent: WO 2006/035244 (2006-04-01), None
patent: WO 2006/046080 (2006-05-01), None
Ishikawa et al. Biochemical Pharmacology (1998), vol. 55, pp. 1091-1097.
Naoto Takahashi et al. “Sequence-dependent Synergistic Cytotoxicity of Ecteinascidin-743 and Paclitaxel in Human Breast Cancer Cell Lines in Vitro and in Vivo,”Cancer Research, No. 62, pp. 6909-6915 (Dec. 1, 2002).
U.S. Appl. No. 09/546,877, filed Apr. 10, 2000, Rinehart.
U.S. Appl. No. 09/787,461, filed Mar. 2, 2001, Cvitkovich et al.
U.S. Appl. No. 10/416,086, filed Sep. 17, 2003, Takahashi et al.
U.S. Appl. No. 10/492,320, filed Oct. 21, 2002, Jimeno et al.
U.S. Appl. No. 10/524,152, filed Aug. 13, 2003, Esteban et al.
U.S. Appl. No. 10/540,092, filed Dec. 18, 2003, Iglesias et al.
U.S. Appl. No. 10/558,133, filed Nov. 15, 2006, D'Incalci et al.
U.S. Appl. No. 10/575,132, filed Oct. 14, 2004, Donald et al.
U.S. Appl. No. 10/579,130, filed May 12, 2006, Rowinsky et al.
U.S. Appl. No. 10/579,251, filed Oct. 20, 2006, Gianni et al.
U.S. Appl. No. 11/132,466, filed May 18, 2005, Rinehart et al.
U.S. Appl. No. 11/261,876, filed Oct. 28, 2005, Beijnen et al.
U.S. Appl. No. 11/576,115, filed Sep. 28, 2005, Allavena et al.
U.S. Appl. No. 11/577,790, filed Apr. 23, 2007, Gilles et al.
U.S. Appl. No. 11/769,873, filed Jun. 28, 2007, Cvitkovich et al.
Akers, “Excipient -Drug Interactions in Parenteral Formulations,” Journal of Pharmaceutical Sciences, 91(11), pp. 2283-2300, Nov. 2002.
Barrera, H. et al., “Interaction of ET-743 and standard cytotoxic agents against a panel of human tumor cell lines,” Proceedings of the American Association for Cancer Research, vol. 40, p. 591, Abstract No. 3896, Mar. 1999.
Biroccio et al., “Telomere Dysfunction Increases Cisplatin and Ecteinascidin-743 Sensitivity of Melanoma Cells,” Molecular Pharmacology, 63:632-638 (2003).
Blay et al., “Combination of Trabectedin and Doxorubicin for the Treatment of Patients with Soft Tissue Sarcoma: Safety and Efficacy Analysis,” 43rdannual ASCO meeting, Jun. 1-5, 2007.
Bonfanti et al., “Effect ofEcteinascidin-743 on the Interaction Between DNA Binding Proteins and DNA.” Anticancer Drug Des. 14, 179-86, 1999.
Bowman, A. et al., “Phase I clinical and pharmacokinetic (PK) study of ecteinascidin-743 (ET-743) given as a one hour infusion every 21 days,”Annals Oncology, Abstract 452, 1998.
Brandon et al., In-vitro Cytotoxicity of ET-743 (Trabectedin, Yondelis), a Marine Anti-cancer Drug, in the Hep G2 Cell Line: Influence of Cytochrome P450 and Phase II Inhibition, and Cytochrome P450 Induction, Anti-cancer Drugs, 16:935-943 (2005).
Burstein et al., “Phase I study of Doxil and Vinorelbine in Metastatic Breast Cancer,” Annals of Oncology, vol. 10, pp. 1113-1116, 1999, XP8086751.
European Agency for the Evaluation of Medicinal Products, “Committee for Proprietary Medicinal Products Summary of Opinion for Yondelis”, Nov. 20, 2003.
Corey et al., “Enantioselective Total Synthesis of Ecteinascidin 743”, J. Am. Chem. Soc., 118, 9202-9203, 1996.
Cvitkovic, E. et al., “Final results of a phase I study of ecteinascidin-743 (ET-743) 24 hour (h) continuous infusion (CI) in advanced solid tumors (AST) patients (pts),” 1999 ASCO Annual Meeting Proceedings, Abstract No. 690, May 15-18, 1999.
Cvitkovic, E. et al., “Ecteinascidin-743 (ET-743) 24 hour continuous intravenous infusion (CI) phase I study in solid tumors (ST) patients,” Annals Oncology, Abstract 456, 1998.
Delaloge, S. et al., “Ecteinascidin-743: A Marine-Derived Compound in Advanced Pretreated Sarcoma Patients-Preliminary Evidence of Activity”, J. of Clinical Oncology, vol. 19, No. 5, pp. 1248-1255, 2001.
DeVita et al., “Combination Versus Single Agent Chemotherapy: A Review of the Basis for Selection of Drug Treatment of Cancer”, Cancer, vol. 35, pp. 98-110, 1975.
D'Incalci et al., “The Combination of ET-743 and Cisplatin (DDP): From a Molecular Pharmacology Study to a Phase I Clinical Trial,” from the AACR Annual Meeting of Apr. 6-10, 2002, Abstract 404.
D'Incalci et al., “Preclinical and Clinical Results with the Natural Marine Product ET-743,” Expert Opin. Investig. Drugs, 12(11):1843-1853 (2003).
D'Incalci et al., “In human tumor xenografts the resistance to ET-743 or to cisplatin can be overcome by giving the two drugs in combination,” European Journal of Cancer, 38, Suppl. 7, 34 (Nov. 2002).
D'Incalci et al., “The combination of yondelis and cisplatin is synergistic against human tumor xenografts,” European Journal of Cancer 39: 1920-1926 (2003).
Donald et al., “Complete Protection By High-Dose Dexamethasone Against The Hepatotoxicity of the Novel Antitumor Drug Yondelis (ET-743) in The Rat,” Cancer Research, vol. 63, p. 5902-5908, Sep. 2003.
Donald et al., “Dietary Agent Indole-3-Carbinol Protects Female Rats Against the Hepatotoxicity of the Antitumor Drug ET-743 (trabectidin) Without Compromising Efficacy in a Rat Mammary Carcinoma” International Journal Of Cancer,—vo1. 111, No. 6, p. 961-967, 2004.
Dorr and Van Hoff, “Doxorubicin,” Cancer Chemotherapy Handbook, 1994, pp. 395-416.
“Doxil (doxorubicin Hcl Liposome Injection) Product Information”, Oct. 10, 2004, pp. 1-16, XP002389462, <<web.archive.org/web/20041009180>>.
Drugs Fut., “Ecteinascidin-743” vol. 22, No. 11, p. 1279, 1997.
Eckhardt et al., “In vitro Studies of a Novel Marine Cytotoxic, Ecteinascidin (ET-743),” New Drugs and Pharmacology, Annals of Oncology, 7 (Suppl. 5), 131, Abstract 632P (1996).
Endo et al., “Total Synthesis of Ecteinascidin 743”, J. Am. Chem. Soc., 124, 6552-6554, 2002.
Erba et al., “Synergistic cytotoxic effect of ET-743 and cisplatin,” Clinical Cancer Research, vol. 6, Abstract 209 (Nov. 2000).
Erba et al., “Combination of yondelis (ET-743) and oxaliplatin in experimental ovarian cancer,” from the AACR-NCI-EORTC International Conference on Molec
King & Spalding LLP
Lewis Patrick T
Pharma Mar, S.A.U.
Sonnenfeld Kenneth H.
Willis Michael A.
LandOfFree
Combination of ET-743 and a 5-fluorouracil pro-drug for... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Combination of ET-743 and a 5-fluorouracil pro-drug for..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Combination of ET-743 and a 5-fluorouracil pro-drug for... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4117120