Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2006-09-12
2006-09-12
Jiang, S. Anna (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S046000, C514S047000, C514S048000, C514S262100, C514S391000, C514S395000
Reexamination Certificate
active
07105497
ABSTRACT:
The present invention provides a method of optimizing therapeutic efficacy and reducing toxicity associated with 6-mercaptopurine drug treatment of an immune-mediated gastrointestinal disorder such as inflammatory bowel disease. The method of the invention includes the step of determining the level of one or more 6-mercaptopurine metabolites in the patient having an immune-mediated gastrointestinal disorder.
REFERENCES:
patent: 5733915 (1998-03-01), Sandborn
patent: 6355623 (2002-03-01), Seidman et al.
patent: 6680302 (2004-01-01), Seidman et al.
patent: 6987097 (2006-01-01), Seidman et al.
patent: 2001/0006970 (2001-07-01), Seidman et al.
patent: 2002/0082239 (2002-06-01), Seidman et al.
patent: WO 96/30021 (1996-03-01), None
Sandborn (II), “Azathioprine: State of the Art in Inflammatory Bowel Disease,” Scand. Journal Gastroenterology, 33(S225, Supplement 1), 92-99 (1998); Chemical Abstracts, 128(21), p. 8, Abstract No. 252417j (May 25, 1998).
Budavari et al.(eds.), The Merck Index, 11th Edition, Merck & Co., Rahway, NJ, 1989, only p. 916 supplied, see entry #918 (Azathioprine).
Berkow et al. (eds.), The Merck Manual of Diagnosis and Therapy, 16th Edition, Merck & Co., Rahway, NJ, 1992, only pp. 328-330, 826-828 and 830-845 supplied.
Sandborn et al., “Lack of Effect of Intravenous Administration on Time to Respond to Azathioprine for Steroid-Treated Crohn's Disease,” Gastroenterology, 117(3), 527-535 (Sep. 1999).
Belaiche et al., “Therapeutic Drug Monitoring of Azathioprine and 6-Mercaptopurine Metabolites in Crohn Disease,” Scandanavian Journal of Gastroenterology, 2001(1), 71-76.
Bouhnik et al., “Long-term Follow-up of Patients with Crohn's Disease Treated with Azathioprine or 6-Mercaptopurine,” The Lancet, 347, 215-219 (Jan. 27, 1996).
Keuzenkamp-Jansen et al., “Thioprine Methyltransferase: A Review and a Clinical Pilot Study,” Journal of Chromatography B, 678, 15-22 (1996).
Cuffari et al., “6-MP Metabolite Levels: A Potential Guide to Crohn's Disease Therapy,” Gastroenterology, 113(2), 690-692 (Aug. 1997).
Aarbakke et al. “Thiopurine biology and pharmacology.”Trends Pharmacol. Sci.(1997), 18:3-7.
Andersen et al. Pharmacokinetics, dose adjustments, and 6-mercaptopurine/methotrexate drug interactions in two patients with thiopurine methyltransferase deficiency.Acta Paediatr. (1998), 87:108-111.
Balis et al. “Pharmacokinetics and pharmacodynamics of oral methotrexate and mercaptopurine in children with lower risk acute lymphoblastic leukemia: a joint children's cancer group and pediatric oncology branch study.”Blood(1998), 92(10):3569-3577.
Bergan et al. “Monitored high-dose azathioprine treatment reduces acute rejection episodes after renal transplantation.”Transplantation(1998), 66(3):334-339.
Bergen et al. Patterns of azathioprine metabolites in neutrophils, lymphocytes, retriculocytes, and erythrocytes: relevance to toxicity and monitoring in recipients of renal allografts.Ther. Drug Monit.(1997), 19:502-509.
Black et al. “Thiopurine methyltransferase genotype predicts therapy-limiting severe toxicity from azathioprine.”Annals of Internal Medicine(1998), 129(9):716-718.
Bökkerink et al. “6-mercaptopurine: cytotoxicity and biochemical pharmacology in human malignant T-lymphoblasts.”Biochem. Pharm.(1996), 45(7):1455-1463.
Bostrom et al. “Cellular pharmacology of 6-mercaptopurine in acute lymphoblastic leukemia.”The American Journal of Pediatric Hematology/Oncology(1993), 15(1):80-86.
Candy et al. “A controlled double blind study of azathioprine in the management of Crohn's disease.”Gut(1995), 37:674-678.
Cattan et al. “6-Mercaptopurine pharmacokinetics and blood lymphocyte subpopulations in patients with Crohn's disease treated with azathioprine.”Gastroenterol. Clin. Biol.(1998), 22:160-167.
Chan et al. “Azathioprine metabolism: pharmacokinetics of 6-mercaptopurine, 6-thiouric acid and 6-thioguanine nucleotides in renal transplant patients.”J. Clin. Pharmacol.(1990), 30:358-363.
Chrzanowska et al. “Determination of 6-thioguanine and 6-methylmercaptopurine metabolites in renal transplantation recipients and patients with glomerulonephritis treated with azathiprine.”Ther. Drug Monit.(1999), 21:231-237.
Colonna et al. “The role of leukopenia in the 6-mercaptopurine-induced remission of refractory Crohn's disease.”Amer. J. Gastroenterology(1994), 89:362-366.
Connell et al. “Bone morrow toxicity caused by azathioprine in inflammatory bowel disease.”Gut(1993), 34:1081-1085.
Coulthard et al. “The relationship between thiopurine methyltransferase activity and genotype in blasts from patients with acute leukemia.”Blood(1998), 92(8):2856-2862.
Cuffari et al. “6-Mercaptopurine metabolism in Crohn's disease: correlation with efficacy and toxicity.”Gut(1996), 39:401-406.
Cuffari et al. “Quantitation of 6-thioguanine in peripheral blood leukocyte DNA in Crohn's disease patients on maintenance 6-mercaptopurine therapy.”Can. J. Physiol. Pharmacol.(1996), 74:580-585.
Dervieux et al. “A HPLC method for the monitoring of human red cell 6-thioguanine and methyl 6-mercaptopurine in a single run.”Purine and Pyrimidine Metabolism in Man IX(1998), 140:729-734.
Dervieux et al. “Simultaneous determination of 6-thioguanine and methyl 6-mercaptopurine nucleotides of azathioprine in red blood cells by HPLC.”Clin. Chem.(1998), 44(3):551-555.
Dubinsky et al. “6-MP metabolite levels predict clinical efficacy and drug toxicity in pediatric IBD.”J. Pediatr. Gastro. Nutr.(1998), 27(4):465, abstract 9.
El-Gamel et al. “Effect of allopurinol on the metabolism of azathioprine in heart transplant patients.”Transplantation Proceedings(1998), 30:1127-1129.
Erb et al. “Pharmacokinetics and metabolism of thiopurines in children with acute lymphoblastic receiving 6-thioguanine versus 6-mercaptopurine.”Cancer Chemother. Pharmacol.(1998), 42:266-272.
Ganiere-Monteil et al. “Thiopurine methyl transferase activity: new extraction conditions for high-performance liquid chromatographic assay.”J. Chromatogr. B(1999), 727:235-239.
Giverhaug et al. “Increased concentrations of methylated 6-mercaptopurine metabolites and 6-thioguanine nucleotides in human leukemic cells in vitro by methotrexate.”Biochem. Pharmacol.(1998), 55:1641-1646.
Goldstein et al. “Toxicities and Infections associated with chronic 6-mercaptopurine (6-MP) use in Crohn's disease (CD): Do we need to discontinue treatment?”Gastroenterology(1998), 114(4):G4042.
Hawthorne et al. “Randomized controlled trial of azathioprine withdrawal in ulcerative colitis.”Br. Med. J.(1992), 305:20-22.
Jacqz-Aigrain et al. “Thiopurine methyltransferase activity in a French population: h.p.l.c. assay conditions and effects of drugs and inhibitors.”Br. J. Clin. Pharmac.(1994), 38:1-8.
Kirschner B. “Safety of azathioprine and 6-mercaptopurine in pediatric patients with inflammatory bowel disease.”Gastroenterology(1998), 115(4):813-821.
Klemetsdal et al. “Identification of factors regulating thiopurine methyltransferase activity in a Norwegian population.”Eur. J. Clin. Pharmacol.(1993), 44:147-152.
Kröplin et al. “Determination of thiopurine methyltransferase activity in erythrocytes using 6-thioguanine as the substrate.”Purine and Pyrimidine Metabolism in Man IX, edited by Griesmacher et al., Plenum Press, New York (1998), 142:741-745.
Krynetski et al. “Cancer genetics '98, pharmacogenetics of cancer therapy: getting personal.”Am. J. Hum. Genet.(1998), 63:11-16.
Lennard et al. “Variable 6-mercaptopurine metabolism and treatment outcome in childhood lymphoblastic leukemia.”J. Clin. Oncol. (1989), 7(12):1816-1823.
Lennard et al. “Assay of 6-thioguanine nucleot
Seidman Ernest G.
Theoret Yves
Crane L. E.
Hopital Sainte-Justine
Jiang S. Anna
Townsend and Townsend / and Crew LLP
LandOfFree
Methods of optimizing drug therapeutic efficacy 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 Methods of optimizing drug therapeutic efficacy for..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods of optimizing drug therapeutic efficacy for... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3530053