Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2005-12-27
2005-12-27
Jones, Dwayne (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S690000, C514S691000
Reexamination Certificate
active
06979688
ABSTRACT:
A method and composition is provided for organ rescue wherein a specific counter-measure is applied locally to a tissue at risk for or exhibiting an adverse side effect of a cancer treatment. More particularly, the method and composition is directed at controlling Hand-Foot Syndrome, a painful redness and cracking of the skin of the hands and feet which can occur with systemic treatment with 5-fluorouracil or a precursor thereof. Uracil ointment is applied to the skin of the hands and feet to prevent Hand-Foot Syndrome which can occur from systemic administration of 5-fluorouracil (or precursor thereof) as cancer treatment.
REFERENCES:
Cao, S. et al., “5-Fluorouracil Prodrug: Role of Anabolic and Catabolic Pathway Modulation in Therapy of Colorectal Cancer”, Clinical Cancer Research, vol. 1, pp. 839-845, Aug. 1995.
Goodman & Gilman's The Pharmacological Basis of Therapeutics, 9thEdition, 1996, pp. 1225-1229.
Stein, J. H., Editor-in-Chief, Internal Medicine, 4th Edition, Chapters 71 and 72, 1994.
Chua D. et al., Proc Am Soc Clin Oncol 22. “Efficacy of capecitabine monotherapy in patients with recurrent and metastatic nasopharyngeal carcinoma pretreated with platinum-based chemotherapy,” p. 511, 2003.
Childress J. et al., American Journal of Clinical Oncology, vol. 26, No. 5. “Cutaneous Hand and Foot Toxicity Associated with Cancer Chemotherapy,” pp. 435-436, Oct. 2003.
Powis, G., International Encyclopedia of Pharmacology and Therapeutics, Anticancer Drugs: Antimetabolite Metabolism and Natural Anticancer Agents, pp 42-50, 1994.
Elasmar, et al., Jpn J Clin Oncol 2001; 31(4)172-174. Case Report: Hand-Foot Syndrome Induced by Oral Fluoropyrimidine S-1.
Ehrlanger M. et al., Dermatologica 140, Suppl. I. “Cutaneous Absorption and Urinary Excretion of 6-14C-5-Fluorouracil Ointment Applicated in an Ointment to Healthy and Diseased Human Skin,” pp. 129-136, 1970.
Fischel J-L., et al., Proceedings of the American Association for Cancer Research, vol. 45. “Experimental arguments for a better understanding of hand-foot syndrome under capecitabine,” p. 487, Mar. 2004.
Findlay M. et al., Annals of Oncology 7:47-53. “Measurement of plasma 5-fluorouracil by high-performance liquid chromatography with comparison of results to tissue drug levels observed using in vivo 19F magnetic resonance spectroscopy in patients in protracted venous infusion with or without interferon-α,” pp. 111-117, 1996.
Fujii S. et al., Gann, 70. “Effect of Coadministration of Uracil or Cytosine on the Anti-Tumor Activity of Clinical Doses of 1-(2-Tetrahydrofuryl)-5-Fluorouracil and Level of 5-Fluorouracil in Rodents,” pp. 209-214, Apr., 1979.
Fukushima S, et al., Cancer Research 52. “Carcinogenicity of Uracil, a Nongenotoxic Chemical, in Rats and Mice and Rationale,” pp. 188-193, Apr. 1, 1992.
Gallo R, et al., The Journal of Clinical Investigation, vol. 48, “The Enzymatic Mechanisms for Deoxythymidine Synthesis in Human Leukocites,” pp. 82-93, 1969.
Hatfield D., et al., The Journal of Biological Chemistry. “Synthesis of (3-Ribosyluric Acid) 5′-Phosphate and (3-Ribosylxanthine) 5′-Phosphate by a Pyrimidine Ribonucleotide Pyrophosphorylase of Beef Erythrocytes,” pp. 60-66, Aug. 1964.
Paulo Hoff, Investigational New Drugs 18. “The tegafur-based dihydropyrimidine dehydrogenase inhibitory fluoropyrimidines, UFT/leucovorin (ORZEL™) and S-1:a review of their clinical development and therapeutic potential,” pp. 153-163, 2000.
Ichikawa W., et al., British Journal of Cancer (2003) 89. “Both gene expression for orotate phosphoribosyltransferase and its ratio to dihydropyrimidine dehydrogenase influence outcome following fluoropyrimidine-based chemotherapy for metastatic colorectal cancer,” 2003 Cancer Research UK.
Ikenaka K., et al., Gann, 70. “Effect of Uracil on Metabolism of 5-Fluorouracil in Vitro,” pp. 353-359, Jun., 1979.
Johnson M., et al., Clinical Cancer Research, vol. 5. “Life-Threatening Toxicity in a Dihydropyrimidine Dehydrogenase-Deficient Patient after Treatment with Topical 5-Fluorouracil,” pp. 141-146, Aug. 1999.
Kawaguchi Y., et al., Gann, 71. “Studies on the Metabolism of 1-(2-Tetrahydrofury)-5-Fluorouracil and Uracil Co-Adminstered Orally to Tumor-Bearing Rats,” pp. 889-899, Dec., 1980.
Largillier R., et al., General Poster Session. “Prospective Analysis of Dihydropyrimidine Dehydrogenase (Dpd) Activity for Predicting Capecitabin-Related Toxicities in Metastatic Breast Cancer Patients,” p. 39, Mon, 9:00 AM—1:00 PM, 2002.
Leo S., et al., Journal of Chemotherapy, vol. 6, n. 6 “Dermatological Toxicity from Chemotherapy Containing 5-Fluorouracil,” pp. 2-5, 1994.
Levy S., et al. Clinical Therapeutics/vol. 23, No. 6, “A Pharmacokinetic Evaluation of 0.5% and 5% Fluorouracil Topical Cream in Patients with Actinic Keratosis,” pp. 908-920, 2001.
Luccioni, et al., Int. J. Cancer: 58, “Pyrimidine Nucleotide Metabolism in HUman Colon Carcinomas: Comparison of Normal Tissues Primary Tumors and Xenografts,” pp. 32-37, 1994.
Mackean M., et al., Journal of Clinical Oncology, vol. 16, No. 9, “Phase I and Pharmacologic Study of Intermittent Twice-Daily Oral Therapy with Capecitabine in Patients with Advanced and/or Metastatic Cancer,” pp. 2977-2985, Sep., 1998.
Machara Y., et al., Oncology, vol. 11, No. 9, “Scientific Basis for the Combination of Tegafur with Uracil,” pp. 14-21, Supplement No. 10, 2001.
Malet-Martino M., et al., The Oncologist 2002, “Clinical Studies of Three Oral Prodrugs of 5-Fluorouracil (Capecitabine, UFT, S-1): A Review,” pp. 288-323.
Niedzwicki J., et al., Biochemical Pharmacology, vol. 32, No. 3, “Structure-Activity Relationship of LIgands of the Pyrimidine Nucleoside Phosphorylases,” pp. 399-415, 1983.
Niedzwicki J., et al., Biochemical Pharmacology, vol. 33, No. 15, “Structure-Activity Relationship of Pyrimidine Base Analogs as Ligands of Orotate Phosphoribosyltransferase,” pp. 2383-2395, 1984.
Naguib, et al., Cancer Research 45, “Enzymes of Uracil Catabolism in Normal and Neoplastic Human Tissues,” pp. 5405-5412, Nov. 1985.
Spicer E., et al., “Toxicity Study of Uracil in Dogs,” pp. 199-204, 2003.
Senff H., et al., British Journal of Dermatology 118, “Topical 5-Fulorouracil Solution in the Treatment of Warts—Clinical Experience and Percutaneous Absorption,” pp. 409-414, 1988.
Sawada N., et al., Clinical Cancer Research, vol. 4, “Induction of Thymidine Phosphorylase Activity and Enhancement of Capecitabine Efficacy by Taxol/Taxotere in Human Cancer Xenografts,” pp. 1013-1019, Apr. 1998.
Sludden J., et al., Pharmacology, “Liver Dihydropyrimidine Dehydrogenase Activity in Human, Cynomolgus Monkey, Rhesus Monkey, Dog, Rat and Mouse,” pp. 276-280, 1998.
Wang J., et al., Anticancer Research 24, “Oral 5-FU is a More Effective Antimetastatic Agent than UFT,” pp. 1353-1360 (2004).
Ichikawa W., et al., Gastrointestinal Cancer, “Polymorphisms of orotate phosphoribosyl transferase (OPRT) gene and thymidylate synthase tandem repeat (TSTR) predict adverse events (AE) in colorectal cancer (CRC) patients treated with 5-fluorouracil (FU) pluis leucovorin (LV),” p. 1063, 2003.
Schilsky R.L., et al., Food and Drug Administration Center for Drug Evaluation and Reseach, “Sixty-Third Meeting of the Oncologic Drug Advisory Committee”, Sep. 16, 1999.
Unknown, Oncology News International, “Lower Dose Capecitabine Is Active and Has Favorable Safety Profile in Elderly Patients With Advanced Breast Cancer,” p. 40, Aug. 2003.
Unknown, Roche Pharmaceuticals, “Xeloda (capecitabine) Tablets,” Apr. 2003.
Samid, D., Roche Laboratories Inc., “Important Information About Xeloda (capecitabine) Tablets,” Aug. 2003
Becker Daniel M.
Dechert LLP
Jones Dwayne
LandOfFree
Treatment method against side-effects of chemotherapy does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Treatment method against side-effects of chemotherapy, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Treatment method against side-effects of chemotherapy will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3514705