Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Patent
1996-12-30
2000-12-26
Jarvis, William R. A.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
A61K 31195
Patent
active
061660795
ABSTRACT:
Methods for treating, preventing, controlling the growth of and/or reducing the risk of developing cervical cancer, particularly in patients with cervical intraepithelial neoplasia are provided employing pharmaceutically acceptable preparations of DFMO. Methods for treating a patient having cervical intraepithelial neoplasia, which methods comprise administering DFMO alone or in combination with a cytotoxic or cytostatic agent, are also provided.
REFERENCES:
Mitchell, et al., "Decreased PCNA Expression in Cervical Premalignant Lesions After Chemoprevention by .alpha.-Difluoromethylornithine (DFMO)," Proc. Annu. Meet. Am. Assoc. Cancer Res., 37:185, Mar. 1996.
Kelloff, et al., "Strategies for Phase II Cancer Chemoprevention Trials: Cervis, Endometrium and Ovary," J. Cell. Biochem. Suppl., 23:1-9, 1995.
Moon, et al., "Chemoprevention of OH-BBN-Induced Bladder Cancer in Mice by Oltipraz, Alone and in Combination with 4-HPR and DFMO," Anticancer Research, 14(1a):5-11, 1994.
Moon, et al., "Chemoprevention of OH-BBN-Induced Bladder Cancer in Mice by Piroxicam," Carcinogensis, 14:1487-1489, 1993.
Mitchell, et al., "The Natural History of Cervical Intraepithelial Neolasia: An Argument fo Intermediate Endpoint Biomarkers," Cancer Epidemiology, Biomarkers & Prevention, 3:619-626, Oct./Nov. 1994.
"Infection Management, The Risk for Cervical Disease in HIV-Infected Women," A Report from the CDC on Four Studies in New York City, Primary Care & Cancer, Oct. 1991.
Creaven, et al., "Evaluation of .alpha.-Difluoromethylornithine as a Potential Chemopreventive Agent: Tolerance to Daily Oral Administration in Humans," Cancer Epidemiology, Biomarkers & Prevention, 2:243-247, May/Jun. 1993.
Griffin, et al., "Phase I Trial and Pharmacokinetic Study of Intravenous and Oral .alpha.-Difluoromethylornithine," Investigational New Drugs, 5:177-186, 1987.
Carbone, et al., "Phase I and Pharmacokinetics Study of Difluoromethylornithine (DFMO), a Potential Chemopreventive," Proceedings of the American Association for Cancer Research, vol. 32, Mar. 1991.
Croghan, et al., Dose-Related .alpha.-Difluoromethylornithine Ototxicity, Am. J. Clin Oncol CCT) 14(4):331-335, 1991.
Griffin, et al., "Phase I Trial & Pharmacokinetic Study of IV & High Dose Oral .alpha.-Difluoromethylornithine (DFMO)," Proceedings of the American Society of Clinical Oncology Twentieth Annual Meeting, May 6-8, Toronto, Ontario, Canada, 1984.
Horn, et al., "Phase I-II Clinical Trial with Alpha-Difluoromethylornitine--An Inhibitor of Polyamine Biosynthesis," Eur. J. Cancer Clin Oncol., 23(8):1103-1107, 1987.
Kelloff, et al., "Surrogate Endpoint Biomarkers for Phase I Cancer Chemoprevention Trials," Journal of Cellular Biochemistry, Supplement, 19:1-9, 1994.
Kuman, et al., "Interim Guidelines for Management of Abnormal Cervical Cytology," JAMA, 271(23):1866-1869, Jun. 1994.
Mamont, et al., "Anti-Proliferative Properties of DL-.alpha.-Difluoromethylornithine in Cultured Cells A Consequence of he Irreversible Inhibition of Ornithine Decarboxylase," Biochemical and Biophysical Research Communucations, 81(1):58-66, Mar. 1978.
Meyskens, Jr., et al., "Enhancement of Regression of Cervical Intraepithlial Neoplasia I (Moderate Dysplasia) with Topically Applied All-trans-Retinoic Acid: A Randomized Trial," Journal of the National Cancer Institute, 86(7):539-543, Apr. 1994.
Wagner, et al., "Resolution of the Enantiomers of Varous .alpha.-Substituted Ornithne and Lysine Analogs by High-Performance Liquid Chromatography with Chiral Eluant and by Gas Chromatography on Chirasil-Val," Analytical Biochemistry, 164:102-116, 1987.
Creaven, et al., "Phase I Study of Difluoromethylornithine (DFMO) as a Chemopreventive Agent," Proceedings of ASCO, vol. 11, Mar. 1992.
Love, et al., "Randomized Phse I Chemoprevention Dose-Seeking Study of .alpha.-Difluoromethylornithine," Journal of the National Cancer Institute, 85(9):732-737, May 1993.
Garewal, et al., "Low Dose Difluoromethylornithine (DFMO) Produces Significant Changes in Polyamine Content of Upper GI Mucosa in Patients with Barrett's Esophagus," Digestive Disease Week and the 92.sup.nd Annual Meeting of The American Gastroenterological Assocation, New Orleans, LA, May 19-22, 1991.
Nishioka, et al., "Polyamines as Biomarkers of Cervical Intraepithelial Neoplasia," Journal of Cellular Biochemistry, Supplement, 23:87-95, 1995.
Pendyala, et al., "Urinary and Erythrocyte Polyamines During the Evaluation of Oral .alpha.-Difluoromethylornithine in a Phase I Chemoprevention Clinical Trial," Cancer Epidemiology, Biomarkers & Prevention, 2:235-241, May/Jun., 1993.
Crowell, et al., "Chronic Toxicity Studies of the Potential Cancer Preventive 2-(Difluoromethyl)-dl-Ornithine," Fundamental and Applied Toxicology, 22:341-354, 1994.
Mitchell, et al., "Chemoprevention Trials and Surrogate End Point Biomarkers in the Cervix," Cancer Supplement, 76(10)1956-1977, Nov. 1995.
Mitchell, et al., "Chemoprevention Trials in the Cervix: Design, Feasibiliy, and Recruitment," Journal of Cellular Biochemistry, Supplement, 23:104-1112, 1995.
Search Report, Aug. 6, 1996.
Search Report, Aug. 9, 1996.
Follen Michele
Hittelman Walter
Hong Wuan K.
Lotan Reuben
Nishioka Kenji
Board of Regents , The University of Texas System
Jarvis William R. A.
LandOfFree
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