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Items: 19

1.

Safety of biologics, lessons learnt from TGN1412.

Stebbings R, Poole S, Thorpe R.

Curr Opin Biotechnol. 2009 Dec;20(6):673-7. doi: 10.1016/j.copbio.2009.10.002. Epub 2009 Nov 4. Review.

PMID:
19892543
2.

The TeGenero incident and the Duff Report conclusions: a series of unfortunate events or an avoidable event?

Horvath CJ, Milton MN.

Toxicol Pathol. 2009 Apr;37(3):372-83. doi: 10.1177/0192623309332986. Epub 2009 Feb 24. No abstract available.

PMID:
19244218
3.

CD28 superagonists: what makes the difference in humans?

Schraven B, Kalinke U.

Immunity. 2008 May;28(5):591-5. doi: 10.1016/j.immuni.2008.04.003.

4.

Preparing for first-in-man studies: the challenges for translational immunology post-TGN1412.

Dayan CM, Wraith DC.

Clin Exp Immunol. 2008 Feb;151(2):231-4. doi: 10.1111/j.1365-2249.2007.03559.x. Review.

5.
6.

Ethical flaws in the TeGenero trial.

Shamoo A, Woeckner E.

Am J Bioeth. 2007 Feb;7(2):90-2. No abstract available.

PMID:
17366211
7.

Lessons from TGN1412.

Hanke T.

Lancet. 2006 Nov 4;368(9547):1569-70; author reply 1570. No abstract available.

PMID:
17084746
8.

Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412.

Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, Panoskaltsis N.

N Engl J Med. 2006 Sep 7;355(10):1018-28. Epub 2006 Aug 14.

9.

Further lessons from the TGN1412 tragedy.

Goodyear MD.

BMJ. 2006 Aug 5;333(7562):270-1. No abstract available.

10.

Phase I antibody risks, trial safety examined.

Tuma RS.

J Natl Cancer Inst. 2006 Jul 19;98(14):956-8. No abstract available.

PMID:
16849675
11.

TGN1412: scrutinizing preclinical trials of antibody-based medicines.

Hansen S, Leslie RG.

Nature. 2006 May 18;441(7091):282. No abstract available.

PMID:
16710395
12.

Allergy test might have avoided drug-trial disaster.

Weis JH.

Nature. 2006 May 11;441(7090):150. No abstract available.

PMID:
16688147
13.

Expansion of functional endogenous antigen-specific CD4+CD25+ regulatory T cells from nonobese diabetic mice.

Masteller EL, Warner MR, Tang Q, Tarbell KV, McDevitt H, Bluestone JA.

J Immunol. 2005 Sep 1;175(5):3053-9.

14.

Topological requirements and signaling properties of T cell-activating, anti-CD28 antibody superagonists.

Lühder F, Huang Y, Dennehy KM, Guntermann C, Müller I, Winkler E, Kerkau T, Ikemizu S, Davis SJ, Hanke T, Hünig T.

J Exp Med. 2003 Apr 21;197(8):955-66.

15.

Mitochondrial injury. Lessons from the fialuridine trial.

Honkoop P, Scholte HR, de Man RA, Schalm SW.

Drug Saf. 1997 Jul;17(1):1-7. Review.

PMID:
9258627
16.

Depletion of mitochondrial DNA, destruction of mitochondria, and accumulation of lipid droplets result from fialuridine treatment in woodchucks (Marmota monax).

Lewis W, Griniuviene B, Tankersley KO, Levine ES, Montione R, Engelman L, de Courten-Myers G, Ascenzi MA, Hornbuckle WE, Gerin JL, Tennant BC.

Lab Invest. 1997 Jan;76(1):77-87.

PMID:
9010451
17.

Fialuridine accumulates in DNA of dogs, monkeys, and rats following long-term oral administration.

Richardson FC, Engelhardt JA, Bowsher RR.

Proc Natl Acad Sci U S A. 1994 Dec 6;91(25):12003-7.

18.

Mitochondrial toxicity--new adverse drug effects.

Swartz MN.

N Engl J Med. 1995 Oct 26;333(17):1146-8. No abstract available.

PMID:
7565955
19.

Hepatic failure and lactic acidosis due to fialuridine (FIAU), an investigational nucleoside analogue for chronic hepatitis B.

McKenzie R, Fried MW, Sallie R, Conjeevaram H, Di Bisceglie AM, Park Y, Savarese B, Kleiner D, Tsokos M, Luciano C, et al.

N Engl J Med. 1995 Oct 26;333(17):1099-105.

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