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Items: 1 to 50 of 66

1.

Nonclinical assessments of the potential biosimilar PF-06439535 and bevacizumab.

Peraza MA, Rule KE, Shiue MHI, Finch GL, Thibault S, Brown PR, Clarke DW, Leach MW.

Regul Toxicol Pharmacol. 2018 Jun;95:236-243. doi: 10.1016/j.yrtph.2018.03.020. Epub 2018 Mar 21.

2.

Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab).

Derzi M, Johnson TR, Shoieb AM, Conlon HD, Sharpe P, Saati A, Koob S, Bolt MW, Lorello LG, McNally J, Kirchhoff CF, Smolarek TA, Leach MW.

Adv Ther. 2016 Nov;33(11):1964-1982. Epub 2016 Sep 1.

3.

A Synopsis of the "Influence of Epigenetics, Genetics, and Immunology" Session Part A at the 35th Annual Society of Toxicologic Pathology Symposium.

Harrill AH, Moggs JG, Adkins KK, Augustin HG, Johnson RC, Leach MW.

Toxicol Pathol. 2017 Jan;45(1):114-118. doi: 10.1177/0192623316670781. Epub 2016 Oct 5. Review.

PMID:
27708198
4.

The Down Syndrome Information Act: Balancing the Advances of Prenatal Testing Through Public Policy.

Leach MW.

Intellect Dev Disabil. 2016 Apr;54(2):84-93. doi: 10.1352/1934-9556-54.2.84. Review.

PMID:
27028250
5.

Nonproliferative and Proliferative Lesions of the Gastrointestinal Tract, Pancreas and Salivary Glands of the Rat and Mouse.

Nolte T, Brander-Weber P, Dangler C, Deschl U, Elwell MR, Greaves P, Hailey R, Leach MW, Pandiri AR, Rogers A, Shackelford CC, Spencer A, Tanaka T, Ward JM.

J Toxicol Pathol. 2016;29(1 Suppl):1S-125S. doi: 10.1293/tox.29.1S. Epub 2016 Feb 13. Review.

6.

Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges.

Chapman K, Adjei A, Baldrick P, da Silva A, De Smet K, DiCicco R, Hong SS, Jones D, Leach MW, McBlane J, Ragan I, Reddy P, Stewart DI, Suitters A, Sims J.

MAbs. 2016;8(3):427-35. doi: 10.1080/19420862.2016.1145331. Review.

7.

Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics.

Frazier KS, Engelhardt JA, Fant P, Guionaud S, Henry SP, Leach MW, Louden C, Scicchitano MS, Weaver JL, Zabka TS; Society of Toxicologic Pathology Vascular Injury Working Group.

Toxicol Pathol. 2015 Oct;43(7):915-34. doi: 10.1177/0192623315570340. Epub 2015 Feb 26. Review.

PMID:
25722122
8.

Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides.

Engelhardt JA, Fant P, Guionaud S, Henry SP, Leach MW, Louden C, Scicchitano MS, Weaver JL, Zabka TS, Frazier KS; Society of Toxicologic Pathology Vascular Injury Working Group.

Toxicol Pathol. 2015 Oct;43(7):935-44. doi: 10.1177/0192623315570341. Epub 2015 Feb 24. Review.

PMID:
25717082
9.

Comparative nonclinical assessments of the proposed biosimilar PF-05280014 and trastuzumab (Herceptin(®)).

Hurst S, Ryan AM, Ng CK, McNally JM, Lorello LG, Finch GL, Leach MW, Ploch SA, Fohey JA, Smolarek TA.

BioDrugs. 2014 Oct;28(5):451-9. doi: 10.1007/s40259-014-0103-4.

10.

Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®).

Ryan AM, Sokolowski SA, Ng CK, Shirai N, Collinge M, Shen AC, Arrington J, Radi Z, Cummings TR, Ploch SA, Stephenson SA, Tripathi NK, Hurst SI, Finch GL, Leach MW.

Toxicol Pathol. 2014 Oct;42(7):1069-81. doi: 10.1177/0192623313520351. Epub 2014 Mar 6.

PMID:
24604381
11.

Immunogenicity/hypersensitivity of biologics.

Leach MW, Rottman JB, Hock MB, Finco D, Rojko JL, Beyer JC.

Toxicol Pathol. 2014 Jan;42(1):293-300. doi: 10.1177/0192623313510987. Epub 2013 Nov 14.

PMID:
24240973
12.

"Candidatus Mycoplasma haemomacaque" and Bartonella quintana bacteremia in cynomolgus monkeys.

Maggi RG, Mascarelli PE, Balakrishnan N, Rohde CM, Kelly CM, Ramaiah L, Leach MW, Breitschwerdt EB.

J Clin Microbiol. 2013 May;51(5):1408-11. doi: 10.1128/JCM.03019-12. Epub 2013 Feb 13.

13.

Reproductive performance and early postnatal development in interleukin (IL)-13-deficient mice.

Wright DJ, Adkins KK, Minck DR, Bailey S, Warner G, Leach MW.

Birth Defects Res B Dev Reprod Toxicol. 2012 Oct;95(5):346-53. doi: 10.1002/bdrb.21023. Epub 2012 Aug 28.

PMID:
22930549
14.
15.

Pharmacokinetics and toxicology of therapeutic proteins: Advances and challenges.

Vugmeyster Y, Xu X, Theil FP, Khawli LA, Leach MW.

World J Biol Chem. 2012 Apr 26;3(4):73-92. doi: 10.4331/wjbc.v3.i4.73.

16.

Hepatocellular proliferation and hepatocarcinogen bioactivation in mice with diet-induced fatty liver and obesity.

Iatropoulos MJ, Duan JD, Jeffrey AM, Leach MW, Hayes AN, Stedman NL, Williams GM.

Exp Toxicol Pathol. 2013 May;65(4):451-6. doi: 10.1016/j.etp.2012.01.003. Epub 2012 Mar 28.

PMID:
22459205
17.

Resources available for informed prenatal decisions.

Leach MW, Skotko BG.

Genet Med. 2012 Mar;14(3):348-9. doi: 10.1038/gim.2011.58. No abstract available.

PMID:
22391781
18.

Appropriate use of recovery groups in nonclinical toxicity studies: value in a science-driven case-by-case approach.

Pandher K, Leach MW, Burns-Naas LA.

Vet Pathol. 2012 Mar;49(2):357-61. doi: 10.1177/0300985811415701. Epub 2011 Aug 1.

PMID:
21810619
19.

Cytosolic phospholipase A2α blockade abrogates disease during the tissue-damage effector phase of experimental autoimmune encephalomyelitis by its action on APCs.

Thakker P, Marusic S, Stedman NL, Lee KL, McKew JC, Wood A, Goldman SJ, Leach MW, Collins M, Kuchroo VK, Wolf SF, Clark JD, Hassan-Zahraee M.

J Immunol. 2011 Aug 15;187(4):1986-97. doi: 10.4049/jimmunol.1002789. Epub 2011 Jul 11.

20.

Effects of an antagonist of neurokinin receptors 1, 2 and 3 on reproductive hormones in male beagle dogs.

Enright BP, Leach MW, Pelletier G, LaBrie F, McIntyre BS, Losco PE.

Birth Defects Res B Dev Reprod Toxicol. 2010 Dec;89(6):517-25. doi: 10.1002/bdrb.20274.

PMID:
21086439
21.

Survey results on the use of the tissue cross-reactivity immunohistochemistry assay.

Bussiere JL, Leach MW, Price KD, Mounho BJ, Lightfoot-Dunn R.

Regul Toxicol Pharmacol. 2011 Apr;59(3):493-502. doi: 10.1016/j.yrtph.2010.09.017. Epub 2010 Oct 14.

PMID:
20951178
22.

Use of tissue cross-reactivity studies in the development of antibody-based biopharmaceuticals: history, experience, methodology, and future directions.

Leach MW, Halpern WG, Johnson CW, Rojko JL, MacLachlan TK, Chan CM, Galbreath EJ, Ndifor AM, Blanset DL, Polack E, Cavagnaro JA.

Toxicol Pathol. 2010 Dec;38(7):1138-66. doi: 10.1177/0192623310382559. Epub 2010 Oct 6.

PMID:
20926828
23.

Correlation of pharmacodynamic activity, pharmacokinetics, and anti-product antibody responses to anti-IL-21R antibody therapeutics following IV administration to cynomolgus monkeys.

Vugmeyster Y, Allen S, Szklut P, Bree A, Ryan M, Ma M, Spaulding V, Young D, Guay H, Bloom L, Leach MW, O'Toole M, Adkins K.

J Transl Med. 2010 Apr 26;8:41. doi: 10.1186/1479-5876-8-41.

24.

Begacestat (GSI-953): a novel, selective thiophene sulfonamide inhibitor of amyloid precursor protein gamma-secretase for the treatment of Alzheimer's disease.

Martone RL, Zhou H, Atchison K, Comery T, Xu JZ, Huang X, Gong X, Jin M, Kreft A, Harrison B, Mayer SC, Aschmies S, Gonzales C, Zaleska MM, Riddell DR, Wagner E, Lu P, Sun SC, Sonnenberg-Reines J, Oganesian A, Adkins K, Leach MW, Clarke DW, Huryn D, Abou-Gharbia M, Magolda R, Bard J, Frick G, Raje S, Forlow SB, Balliet C, Burczynski ME, Reinhart PH, Wan HI, Pangalos MN, Jacobsen JS.

J Pharmacol Exp Ther. 2009 Nov;331(2):598-608. doi: 10.1124/jpet.109.152975. Epub 2009 Aug 11.

PMID:
19671883
25.

Blockade of cytosolic phospholipase A2 alpha prevents experimental autoimmune encephalomyelitis and diminishes development of Th1 and Th17 responses.

Marusic S, Thakker P, Pelker JW, Stedman NL, Lee KL, McKew JC, Han L, Xu X, Wolf SF, Borey AJ, Cui J, Shen MW, Donahue F, Hassan-Zahraee M, Leach MW, Shimizu T, Clark JD.

J Neuroimmunol. 2008 Nov 15;204(1-2):29-37. doi: 10.1016/j.jneuroim.2008.08.012.

PMID:
18829119
26.

Administration of an antagonist of neurokinin receptors 1, 2, and 3 results in reproductive tract changes in beagle dogs, but not rats.

Losco PE, Leach MW, Sinha D, Davis P, Schmahai TJ, Nomier A, Kakkar T, Reyderman L, Lynch ME.

Toxicol Pathol. 2007 Feb;35(2):310-22.

PMID:
17366326
27.

IL-23 is critical in the induction but not in the effector phase of experimental autoimmune encephalomyelitis.

Thakker P, Leach MW, Kuang W, Benoit SE, Leonard JP, Marusic S.

J Immunol. 2007 Feb 15;178(4):2589-98.

28.

PD-1/PD-L1, but not PD-1/PD-L2, interactions regulate the severity of experimental autoimmune encephalomyelitis.

Carter LL, Leach MW, Azoitei ML, Cui J, Pelker JW, Jussif J, Benoit S, Ireland G, Luxenberg D, Askew GR, Milarski KL, Groves C, Brown T, Carito BA, Percival K, Carreno BM, Collins M, Marusic S.

J Neuroimmunol. 2007 Jan;182(1-2):124-34. Epub 2006 Dec 19.

PMID:
17182110
29.

Cytosolic phospholipase A2 alpha-deficient mice are resistant to experimental autoimmune encephalomyelitis.

Marusic S, Leach MW, Pelker JW, Azoitei ML, Uozumi N, Cui J, Shen MW, DeClercq CM, Miyashiro JS, Carito BA, Thakker P, Simmons DL, Leonard JP, Shimizu T, Clark JD.

J Exp Med. 2005 Sep 19;202(6):841-51.

30.

Central nervous system inflammation and neurological disease in transgenic mice expressing the CC chemokine CCL21 in oligodendrocytes.

Chen SC, Leach MW, Chen Y, Cai XY, Sullivan L, Wiekowski M, Dovey-Hartman BJ, Zlotnik A, Lira SA.

J Immunol. 2002 Feb 1;168(3):1009-17.

31.

IL-25 induces IL-4, IL-5, and IL-13 and Th2-associated pathologies in vivo.

Fort MM, Cheung J, Yen D, Li J, Zurawski SM, Lo S, Menon S, Clifford T, Hunte B, Lesley R, Muchamuel T, Hurst SD, Zurawski G, Leach MW, Gorman DM, Rennick DM.

Immunity. 2001 Dec;15(6):985-95.

33.

Ubiquitous transgenic expression of the IL-23 subunit p19 induces multiorgan inflammation, runting, infertility, and premature death.

Wiekowski MT, Leach MW, Evans EW, Sullivan L, Chen SC, Vassileva G, Bazan JF, Gorman DM, Kastelein RA, Narula S, Lira SA.

J Immunol. 2001 Jun 15;166(12):7563-70.

34.

Regulatory effects of interleukin-4 and interleukin-10 on human neutrophil function ex vivo and on neutrophil influx in a rat model of arthritis.

Bober LA, Rojas-Triana A, Jackson JV, Leach MW, Manfra D, Narula SK, Grace MJ.

Arthritis Rheum. 2000 Dec;43(12):2660-7.

35.

Chronic colitis in IL-10-/- mice: insufficient counter regulation of a Th1 response.

Davidson NJ, Fort MM, Müller W, Leach MW, Rennick DM.

Int Rev Immunol. 2000;19(1):91-121. Review.

PMID:
10723680
36.

Transgenic expression of the chemokine receptor encoded by human herpesvirus 8 induces an angioproliferative disease resembling Kaposi's sarcoma.

Yang TY, Chen SC, Leach MW, Manfra D, Homey B, Wiekowski M, Sullivan L, Jenh CH, Narula SK, Chensue SW, Lira SA.

J Exp Med. 2000 Feb 7;191(3):445-54.

37.

An essential role for interleukin 10 in the function of regulatory T cells that inhibit intestinal inflammation.

Asseman C, Mauze S, Leach MW, Coffman RL, Powrie F.

J Exp Med. 1999 Oct 4;190(7):995-1004.

38.

The role of IL-10 in inflammatory bowel disease: "of mice and men".

Leach MW, Davidson NJ, Fort MM, Powrie F, Rennick DM.

Toxicol Pathol. 1999 Jan-Feb;27(1):123-33. Review.

PMID:
10367687
39.

Renal changes associated with naproxen sodium administration in cynomolgus monkeys.

Leach MW, Frank DW, Berardi MR, Evans EW, Johnson RC, Schuessler DG, Radwanski E, Cartwright ME.

Toxicol Pathol. 1999 May-Jun;27(3):295-306.

PMID:
10356706
40.

Vacuolation in renal tubular epithelium of Cd-1 mice: an incidental finding.

Johnson RC, Dovey-Hartman BJ, Syed J, Leach MW, Frank DW, Sinha DP, Mirro EJ, Little JM, Halliwell WH.

Toxicol Pathol. 1998 Nov-Dec;26(6):789-92.

PMID:
9864096
41.

A role for NK cells as regulators of CD4+ T cells in a transfer model of colitis.

Fort MM, Leach MW, Rennick DM.

J Immunol. 1998 Oct 1;161(7):3256-61.

42.

IL-12, but not IFN-gamma, plays a major role in sustaining the chronic phase of colitis in IL-10-deficient mice.

Davidson NJ, Hudak SA, Lesley RE, Menon S, Leach MW, Rennick DM.

J Immunol. 1998 Sep 15;161(6):3143-9.

43.

Radioprotective effects of flk2/flt3 ligand.

Hudak S, Leach MW, Xu Y, Menon S, Rennick D.

Exp Hematol. 1998 Jun;26(6):515-22.

PMID:
9620285
44.

Safety evaluation of recombinant human interleukin-4. II. Clinical studies.

Leach MW, Rybak ME, Rosenblum IY.

Clin Immunol Immunopathol. 1997 Apr;83(1):12-4.

PMID:
9073527
45.

Safety evaluation of recombinant human interleukin-4. I. Preclinical studies.

Leach MW, Snyder EA, Sinha DP, Rosenblum IY.

Clin Immunol Immunopathol. 1997 Apr;83(1):8-11. Review.

PMID:
9073526
46.

Interleukin-10 is a natural suppressor of cytokine production and inflammation in a murine model of allergic bronchopulmonary aspergillosis.

Grünig G, Corry DB, Leach MW, Seymour BW, Kurup VP, Rennick DM.

J Exp Med. 1997 Mar 17;185(6):1089-99.

47.

Enterocolitis and colon cancer in interleukin-10-deficient mice are associated with aberrant cytokine production and CD4(+) TH1-like responses.

Berg DJ, Davidson N, Kühn R, Müller W, Menon S, Holland G, Thompson-Snipes L, Leach MW, Rennick D.

J Clin Invest. 1996 Aug 15;98(4):1010-20.

48.

T helper cell 1-type CD4+ T cells, but not B cells, mediate colitis in interleukin 10-deficient mice.

Davidson NJ, Leach MW, Fort MM, Thompson-Snipes L, Kühn R, Müller W, Berg DJ, Rennick DM.

J Exp Med. 1996 Jul 1;184(1):241-51.

49.

Evaluation of the disodium salt of 4,4'-diamino-2,2'-stilbene disulfonic acid for estrogenic activity.

Hostetler KA, Leach MW, Hyde TE, Wei LL.

J Toxicol Environ Health. 1996 Jun 7;48(2):141-9.

PMID:
8642622

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