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Polyphenon E

 Polyphenon E is a substance being studied in the prevention of cancer. It is made from decaffeinated green tea, and contains chemicals called catechins, which are antioxidants. Also called green tea extract.

defined green tea catechin extract is a defined, decaffeinated green tea extract, containing polyphenolic flavonol catechins, isolated from the plant Camellia sinensis with antiviral, antioxidant, and potential chemopreventive activities. The primary catechins found in green tea are epicatechin (EC), epigallocatechin (EGC), epicatechin-3 gallate (ECG), and epigallocatechin-3-gallate (EGCG), the most potent. As potential chemopreventive agents, catechins scavenge free radicals; inhibit enzymes involved in cell replication and DNA synthesis; interfere with cell-to-cell contact adhesion; and inhibit various intracellular communication pathways required for cell division. In addition, it has been postulated that EGCG may "trap" growth factors such platelet-derived growth factor (PDGF) on cell membranes, immobilizing growth factors on cell membranes and preventing ligand-receptor crosslinking and growth factor receptor activation. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus)

kunecatechins ointment is a topical ointment containing a green tea polyphenol mixture (kunecatechins) with potential antiviral, antibacterial, antioxidant, and chemopreventive activities. Kunecatechins is a partially purified fraction of the aqueous extract of green tea leaves from Camellia sinensis and contains catechins and other green tea components. Catechins, polyphenolic antioxidant plant metabolites or flavonoids, comprise most of the drug substance in kunecatechins with epigallocatechin gallate (EGCG) present as the primary catechin. Catechins may inhibit basic functions of human papillomavirus (HPV), counteract specific changes in tumor cells, affect cell signaling, and stimulate the immune system. Topical application of kunecatechins ointment has been reported to reduce HPV-induced genital and anal warts through a not yet fully understood mechanism, which may involve anti-oxidative activity. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus)

Current developer:    Polyphenon Pharma

 1: Brizuela L, Dayon A, Doumerc N, Ader I, Golzio M, Izard JC, Hara Y, Malavaud B, Cuvillier O. The sphingosine kinase-1 survival pathway is a molecular target for the tumor-suppressive tea and wine polyphenols in prostate cancer. FASEB J. 2010 Jun 14. [Epub ahead of print] PubMed PMID: 20522783.

2: Zhang Q, Fu H, Pan J, He J, Ryota S, Hara Y, Wang Y, Lubet RA, You M. Effect of dietary Polyphenon E and EGCG on lung tumorigenesis in A/J Mice. Pharm Res. 2010 Jun;27(6):1066-71. Epub 2010 Jan 29. PubMed PMID: 20112129.

3: Tatti S, Stockfleth E, Beutner KR, Tawfik H, Elsasser U, Weyrauch P, Mescheder A. Polyphenon E: a new treatment for external anogenital warts. Br J Dermatol. 2010 Jan;162(1):176-84. Epub 2009 Jul 27. PubMed PMID: 19709100.

4: McLarty J, Bigelow RL, Smith M, Elmajian D, Ankem M, Cardelli JA. Tea polyphenols decrease serum levels of prostate-specific antigen, hepatocyte growth factor, and vascular endothelial growth factor in prostate cancer patients and inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro. Cancer Prev Res (Phila Pa). 2009 Jul;2(7):673-82. Epub 2009 Jun 19. PubMed PMID: 19542190.

5: Shanafelt TD, Call TG, Zent CS, LaPlant B, Bowen DA, Roos M, Secreto CR, Ghosh AK, Kabat BF, Lee MJ, Yang CS, Jelinek DF, Erlichman C, Kay NE. Phase I trial of daily oral Polyphenon E in patients with asymptomatic Rai stage 0 to II chronic lymphocytic leukemia. J Clin Oncol. 2009 Aug 10;27(23):3808-14. Epub 2009 May 26. PubMed PMID: 19470922; PubMed Central PMCID: PMC2727287.

6: Bode AM, Dong Z. Epigallocatechin 3-gallate and green tea catechins: United they work, divided they fail. Cancer Prev Res (Phila Pa). 2009 Jun;2(6):514-7. Epub 2009 May 26. Review. PubMed PMID: 19470792; PubMed Central PMCID: PMC2822459.

7: Fu H, He J, Mei F, Zhang Q, Hara Y, Ryota S, Lubet RA, Chen R, Chen DR, You M. Lung cancer inhibitory effect of epigallocatechin-3-gallate is dependent on its presence in a complex mixture (polyphenon E). Cancer Prev Res (Phila Pa). 2009 Jun;2(6):531-7. Epub 2009 May 26. PubMed PMID: 19470785.

8: Graff S. Research probes anticancer mechanisms of Polyphenon E. J Natl Cancer Inst. 2009 May 6;101(9):627-8. Epub 2009 Apr 28. PubMed PMID: 19401557.

9: Song S, Krishnan K, Liu K, Bresalier RS. Polyphenon E inhibits the growth of human Barrett's and aerodigestive adenocarcinoma cells by suppressing cyclin D1 expression. Clin Cancer Res. 2009 Jan 15;15(2):622-31. PubMed PMID: 19147768.

10: Borgovan T, Bellistri JP, Slack KN, Kopelovich L, Desai M, Joe AK. Inhibition of BCL2 expression and activity increases H460 sensitivity to the growth inhibitory effects of polyphenon E. J Exp Ther Oncol. 2009;8(2):129-44. PubMed PMID: 20192119.

11: Leong H, Mathur PS, Greene GL. Green tea catechins inhibit angiogenesis through suppression of STAT3 activation. Breast Cancer Res Treat. 2009 Oct;117(3):505-15. Epub 2008 Sep 28. PubMed PMID: 18821062.

12: Lu G, Xiao H, You H, Lin Y, Jin H, Snagaski B, Yang CS. Synergistic inhibition of lung tumorigenesis by a combination of green tea polyphenols and atorvastatin. Clin Cancer Res. 2008 Aug 1;14(15):4981-8. PubMed PMID: 18676773.

13: Auger C, Mullen W, Hara Y, Crozier A. Bioavailability of polyphenon E flavan-3-ols in humans with an ileostomy. J Nutr. 2008 Aug;138(8):1535S-1542S. PubMed PMID: 18641203.

14: Anderson MW, Goodin C, Zhang Y, Kim S, Estensen RD, Wiedmann TS, Sekar P, Buncher CR, Khoury JC, Garbow JR, You M, Tichelaar JW. Effect of dietary green tea extract and aerosolized difluoromethylornithine during lung tumor progression in A/J strain mice. Carcinogenesis. 2008 Aug;29(8):1594-600. Epub 2008 May 29. PubMed PMID: 18515278; PubMed Central PMCID: PMC2516483.

15: Stockfleth E, Beti H, Orasan R, Grigorian F, Mescheder A, Tawfik H, Thielert C. Topical Polyphenon E in the treatment of external genital and perianal warts: a randomized controlled trial. Br J Dermatol. 2008 Jun;158(6):1329-38. Epub 2008 Mar 20. PubMed PMID: 18363746.

16: Haque AM, Hashimoto M, Katakura M, Hara Y, Shido O. Green tea catechins prevent cognitive deficits caused by Abeta1-40 in rats. J Nutr Biochem. 2008 Sep;19(9):619-26. Epub 2008 Feb 15. PubMed PMID: 18280729.

17: Gross G. [Polyphenon E. A new topical therapy for condylomata acuminata]. Hautarzt. 2008 Jan;59(1):31-5. Review. German. PubMed PMID: 18209999.

18: Foster DR, Sowinski KM, Chow HH, Overholser BR. Limited sampling strategies to estimate exposure to the green tea polyphenol, epigallocatechin gallate, in fasting and fed conditions. Ther Drug Monit. 2007 Dec;29(6):835-42. PubMed PMID: 18043484.

19: Gross G, Meyer KG, Pres H, Thielert C, Tawfik H, Mescheder A. A randomized, double-blind, four-arm parallel-group, placebo-controlled Phase II/III study to investigate the clinical efficacy of two galenic formulations of Polyphenon E in the treatment of external genital warts. J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1404-12. PubMed PMID: 17958849.

20: Hao X, Sun Y, Yang CS, Bose M, Lambert JD, Ju J, Lu G, Lee MJ, Park S, Husain A, Wang S. Inhibition of intestinal tumorigenesis in Apc(min/+) mice by green tea polyphenols (polyphenon E) and individual catechins. Nutr Cancer. 2007;59(1):62-9. PubMed PMID: 17927503.

21: Xiao H, Hao X, Simi B, Ju J, Jiang H, Reddy BS, Yang CS. Green tea polyphenols inhibit colorectal aberrant crypt foci (ACF) formation and prevent oncogenic changes in dysplastic ACF in azoxymethane-treated F344 rats. Carcinogenesis. 2008 Jan;29(1):113-9. Epub 2007 Sep 24. PubMed PMID: 17893236.

22: Chow HH, Hakim IA, Vining DR, Crowell JA, Tome ME, Ranger-Moore J, Cordova CA, Mikhael DM, Briehl MM, Alberts DS. Modulation of human glutathione s-transferases by polyphenon e intervention. Cancer Epidemiol Biomarkers Prev. 2007 Aug;16(8):1662-6. PubMed PMID: 17684143.

23: Lubet RA, Yang CS, Lee MJ, Hara Y, Kapetanovic IM, Crowell JA, Steele VE, Juliana MM, Grubbs CJ. Preventive effects of polyphenon E on urinary bladder and mammary cancers in rats and correlations with serum and urine levels of tea polyphenols. Mol Cancer Ther. 2007 Jul;6(7):2022-8. PubMed PMID: 17620432.

24: Adachi S, Nagao T, Ingolfsson HI, Maxfield FR, Andersen OS, Kopelovich L, Weinstein IB. The inhibitory effect of (-)-epigallocatechin gallate on activation of the epidermal growth factor receptor is associated with altered lipid order in HT29 colon cancer cells. Cancer Res. 2007 Jul 1;67(13):6493-501. PubMed PMID: 17616711.

25: Yan Y, Cook J, McQuillan J, Zhang G, Hitzman CJ, Wang Y, Wiedmann TS, You M. Chemopreventive effect of aerosolized polyphenon E on lung tumorigenesis in A/J mice. Neoplasia. 2007 May;9(5):401-5. PubMed PMID: 17534445; PubMed Central PMCID: PMC1877981.

26: Leong H, Mathur PS, Greene GL. Inhibition of mammary tumorigenesis in the C3(1)/SV40 mouse model by green tea. Breast Cancer Res Treat. 2008 Feb;107(3):359-69. Epub 2007 May 5. PubMed PMID: 17484049.

27: Hede K. Imprinting may provide cancer prevention tools. J Natl Cancer Inst. 2007 Mar 21;99(6):424-6. PubMed PMID: 17374829.

28: Ikeda M, Suzuki C, Umegaki K, Saito K, Tabuchi M, Tomita T. Preventive effects of green tea catechins on spontaneous stroke in rats. Med Sci Monit. 2007 Feb;13(2):BR40-5. PubMed PMID: 17261979.

29: Mohan KV, Gunasekaran P, Varalakshmi E, Hara Y, Nagini S. In vitro evaluation of the anticancer effect of lactoferrin and tea polyphenol combination on oral carcinoma cells. Cell Biol Int. 2007 Jun;31(6):599-608. Epub 2006 Dec 5. PubMed PMID: 17258915.

30: Elmore E, Jain A, Siddiqui S, Tohidian N, Meyskens FL, Steele VE, Redpath JL. Development and characteristics of a human cell assay for screening agents for melanoma prevention. Melanoma Res. 2007 Feb;17(1):42-50. PubMed PMID: 17235241.

31: Lu G, Liao J, Yang G, Reuhl KR, Hao X, Yang CS. Inhibition of adenoma progression to adenocarcinoma in a 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone-induced lung tumorigenesis model in A/J mice by tea polyphenols and caffeine. Cancer Res. 2006 Dec 1;66(23):11494-501. PubMed PMID: 17145898.

32: Chandra Mohan KV, Subapriya R, Hara Y, Nagini S. Enhancement of erythrocyte antioxidants by green and black tea polyphenols during 7,12-dimethylbenz[a]anthracene-induced hamster buccal pouch carcinogenesis. J Med Food. 2006 Fall;9(3):373-7. PubMed PMID: 17004901.

33: Haque AM, Hashimoto M, Katakura M, Tanabe Y, Hara Y, Shido O. Long-term administration of green tea catechins improves spatial cognition learning ability in rats. J Nutr. 2006 Apr;136(4):1043-7. PubMed PMID: 16549472.

34: Bayés M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods Find Exp Clin Pharmacol. 2006 Jan-Feb;28(1):31-63. PubMed PMID: 16541195.

35: Yan Y, Wang Y, Tan Q, Hara Y, Yun TK, Lubet RA, You M. Efficacy of polyphenon E, red ginseng, and rapamycin on benzo(a)pyrene-induced lung tumorigenesis in A/J mice. Neoplasia. 2006 Jan;8(1):52-8. PubMed PMID: 16533426; PubMed Central PMCID: PMC1584290.

36: Lu Y, Yao R, Yan Y, Wang Y, Hara Y, Lubet RA, You M. A gene expression signature that can predict green tea exposure and chemopreventive efficacy of lung cancer in mice. Cancer Res. 2006 Feb 15;66(4):1956-63. PubMed PMID: 16488994.

37: Chandra Mohan KV, Hara Y, Abraham SK, Nagini S. Comparative evaluation of the chemopreventive efficacy of green and black tea polyphenols in the hamster buccal pouch carcinogenesis model. Clin Biochem. 2005 Oct;38(10):879-86. PubMed PMID: 16098960.

38: Henning SM, Niu Y, Liu Y, Lee NH, Hara Y, Thames GD, Minutti RR, Carpenter CL, Wang H, Heber D. Bioavailability and antioxidant effect of epigallocatechin gallate administered in purified form versus as green tea extract in healthy individuals. J Nutr Biochem. 2005 Oct;16(10):610-6. PubMed PMID: 16081270.

39: Chow HH, Hakim IA, Vining DR, Crowell JA, Ranger-Moore J, Chew WM, Celaya CA, Rodney SR, Hara Y, Alberts DS. Effects of dosing condition on the oral bioavailability of green tea catechins after single-dose administration of Polyphenon E in healthy individuals. Clin Cancer Res. 2005 Jun 15;11(12):4627-33. PubMed PMID: 15958649.

40: Shimizu M, Deguchi A, Lim JT, Moriwaki H, Kopelovich L, Weinstein IB. (-)-Epigallocatechin gallate and polyphenon E inhibit growth and activation of the epidermal growth factor receptor and human epidermal growth factor receptor-2 signaling pathways in human colon cancer cells. Clin Cancer Res. 2005 Apr 1;11(7):2735-46. PubMed PMID: 15814656.

41: Elmore E, Siddiqui S, Navidi M, Steele VE, Redpath JL. Correlation of in vitro chemopreventive efficacy data from the human epidermal cell assay with animal efficacy data and clinical trial plasma levels. J Cell Biochem. 2005 Jun 1;95(3):571-88. PubMed PMID: 15786488.

42: Bayés M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods Find Exp Clin Pharmacol. 2004 Apr;26(3):211-44. PubMed PMID: 15148527.

43: Ahn WS, Yoo J, Huh SW, Kim CK, Lee JM, Namkoong SE, Bae SM, Lee IP. Protective effects of green tea extracts (polyphenon E and EGCG) on human cervical lesions. Eur J Cancer Prev. 2003 Oct;12(5):383-90. PubMed PMID: 14512803.

44: Chow HH, Cai Y, Hakim IA, Crowell JA, Shahi F, Brooks CA, Dorr RT, Hara Y, Alberts DS. Pharmacokinetics and safety of green tea polyphenols after multiple-dose administration of epigallocatechin gallate and polyphenon E in healthy individuals. Clin Cancer Res. 2003 Aug 15;9(9):3312-9. PubMed PMID: 12960117.

45: Bayés M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods Find Exp Clin Pharmacol. 2003 Jul-Aug;25(6):483-506. PubMed PMID: 12949633.

46: Hisano M, Yamaguchi K, Inoue Y, Ikeda Y, Iijima M, Adachi M, Shimamura T. Inhibitory effect of catechin against the superantigen staphylococcal enterotoxin B (SEB). Arch Dermatol Res. 2003 Sep;295(5):183-9. Epub 2003 Jul 17. PubMed PMID: 12883826.

47: Chang PY, Mirsalis J, Riccio ES, Bakke JP, Lee PS, Shimon J, Phillips S, Fairchild D, Hara Y, Crowell JA. Genotoxicity and toxicity of the potential cancer-preventive agent polyphenon E. Environ Mol Mutagen. 2003;41(1):43-54. PubMed PMID: 12552591.

48: Chow HH, Cai Y, Alberts DS, Hakim I, Dorr R, Shahi F, Crowell JA, Yang CS, Hara Y. Phase I pharmacokinetic study of tea polyphenols following single-dose administration of epigallocatechin gallate and polyphenon E. Cancer Epidemiol Biomarkers Prev. 2001 Jan;10(1):53-8. PubMed PMID: 11205489.

49: Hirose M, Mizoguchi Y, Yaono M, Tanaka H, Yamaguchi T, Shirai T. Effects of green tea catechins on the progression or late promotion stage of mammary gland carcinogenesis in female Sprague-Dawley rats pretreated with 7,12-dimethylbenz(a)anthracene. Cancer Lett. 1997 Jan 30;112(2):141-7. PubMed PMID: 9066720.