Methods of optimizing drug therapeutic efficacy for...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

Reexamination Certificate

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C514S046000, C514S047000, C514S048000, C514S262100, C514S391000, C514S395000

Reexamination Certificate

active

06987097

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: 2001/0006970 (2001-07-01), Seidman et al.
patent: WO96/30021 (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 p. 328-330, 826-828 and 839-845 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 Treated with Azathioprine of 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).
El Gamel et al.,Transplantation Proceedings,30:1127-1129 (1998).
Giverhaug et al.,Biochem. Pharmacol.,55:1641-1646 (1998).
John M. Benassi (Paul Hastings): Letter Brief Regarding the Need for Fact Discovery; Dec. 3, 2004: submitted in Civil Action No. 04 CV 1200 JAH (RBB) titled Promeltheus Laboratories, Inc. v. Mayo Collaborative Service dba Mayo Medical Laboratories.
Juanita Brooks & Jonathan Singer (Fish & Richardson P.C.); Response to Plaintiff's Letter Brief Regarding the Need for Fact Discovery: Dec. 10, 2004; submitted in Civil Action No. 04 CV 1200 JAH (RBB) titled Prometheus Laboratories, Inc. v. Mayo Collaborative Services dba Mayo Medical Laboratories.
Aarbakke et al., “Thiopurine biology and pharmacology,”Trends Pharmacol. Sci.18:3-7 (1997).
Anderson et al., “Pharmacokinetics, dose adjustments, and 6-mercaptopurine/methotrexate drug interactions in two patients with thiopurine methyltransferase deficiency,”Acta Paediatr.,87:108-111 (1998).
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,92(10):3569-3577 (1998).
Bergan et al., “Monitored high-dose azathioprine treatment reduces acute rejection episodes after renal transplantation,”Transplantation,66(3):334-339 (1988).
Bergan et al., “Patterns of azathioprine metabolites in neutrophils, lymphocytes, retriculocytes, and erythrocytes: relevance to toxicity and monitoring in recipients of renal allografts,”Ther. Drug. Monitor.,19:502-509 (1997).
Black et al., “Thiopurine methyltransferase genotype predicts therapy-limiting severe toxicity from azathioprine,”Annals of Internal Medicine,129(9):716-718 (1998).
Bökkerink et al., “6-mercaptopurine: cytotoxicity and biochemical pharmacology in human malignant T-lymphoblasts,”Biochem. Pharm.,45(7):1455-1463 (1996).
Bostrom and Erdmann, “Cellular pharmacology of 6-mercaptopurine in acute lymphoblastic leukemia,”The American Journal of Pediatric Hematology/Oncology,15(1):80-86 (1993.
Candy et al., “A controlled double-blind study of azathioprine in the management of Crohn's disease,”Gut,37:674-678 (1995).
Cattan et al., “6-Mercaptopurine pharmacokinetics and blood lymphocyte subpopulations in patients with Crohn's disease treated with azathioprine,”Gastroenterol. Clin. Biol.,22:160-167 (1998).
Chan et al., “Azathioprine metabolism: pharmacokinetics of 6-mercaptopurine, 6-thiouric acid and 6-thioguanine nucleotides in renal transplant patients,”J. Clin. Pharmacol. ,30:358-363 (1990).
Chrzanowska and Krzymanski, “Determination of 6-thioguanine and 6-methylmercaptopurine metabolites in renal transplantation recipients and patients with glomerulonephritis treated with azathioprine,”Ther. Drug Monit.,21:231-237 (1999).
Colonna and Korelitz, “The role of leukopenia in the 6-mercaptopurine-induced remission of refractory Crohn's disease,”Amer. J. Gastroenterology,89:362-366 (1994).
Connell et al., “Bone marrow toxicity caused by azathioprine in inflammatory bowel disease,”Gut,34:1081-1085 (1993).
Coulthard et al., “The relationship between thiopurine-methyltransferase activity and genotype in blasts from patients with acute leukemia,”Blood,92(8):2856-2862 (1998).
Cuffari et al., “6-Mercaptopurine metabolism in Crohn's disease: correlation with efficacy and toxicity,”Gut,39:401-406 (1996).
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.,74:580-585 (1996).
Dervieux and Boulieu, “A HPLC method for the monitoring of human and red cell 6-thioguanine and methyl 6-mercaptopurine in a single run,”Purine and Pyrmidine Metabolism in Man IX,140:729-734 (1998).
Dervieux and Boulieu, “Simultaneous determination of 6-thioguanine and methyl 6-mercaptopurine nucleotides of azathioprine in red blood cells by HPLC,”Clin. Chem.,44(3):551-555 (1998).
Dubinsky et al., “6-MP metabolite levels predict clinical efficacy and drug toxicity in pediatric IBD,”J. Pediatr. Gastro. Nutr.,27:465 abstract 9 (1998).
Erb et al., “Pharmacokinetics and metabolism of thiopurines in children with acute lymphoblastic leukemia receiving 6-thioguanine versus 6-mecaptopurine,”Cancer Chemother. Pharmacol.,42:266-272 (1998).
Ganiere-Monteil et al., “Thiopurine methyl transferase activity: new extraction conditions for high-performance liquid chromatographic assay,”J. Chromatogr. B,727:235-239 (1999).
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,114(4):G4042 (1998).
Hawthorne et al., “Randomised controlled trial of azathioprine withdrawal in ulcerative colitis,”Br. Med. J.,305:20-22 (1992).
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.,38:1-8 (1994).
Kirschner B., “Safety of azathioprine and 6-mercaptopurine in pediatric patients with inflammatory bowel disease,”Gastroenterology,115:813-821 (1998).
Klemetsdal et al., “Identification of factors regulating thiopurine and methyltransferase activity in a Norwegian population,”Eur. J. Clin. Pharmacol.,44:147-152 (1993).
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, 142:741-745 (1998).
Krynetski and Evans, “Cancer genetics '98, pharmacogenetics of cance

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