Scientific Publications

EGFRvIII

Sampson JH, Schmittling RJ, Archer GE, Congdon KL, Nair SK, et al. (2012) A Pilot Study of IL-2Rα Blockade during Lymphopenia Depletes Regulatory T-cells and Correlates with Enhanced Immunity in Patients with Glioblastoma. PLoS ONE 7(2): e31046. doi:10.1371/journal.pone.0031046

Li G, Mitra SS, Monje M, Henrich KN, Bangs CD, Nitta RT, Wong AJ. Expression of epidermal growth factor variant III (EGFRvIII) in pediatric diffuse intrinsic pontine gliomas. J Neurooncol. 2012 Mar 2 [Epub ahead of print]

SNO 2011 Presentation - Long-term Follow-up of ACT III: A Phase 2 Trial of Rindopepimut (CDX-110) in Newly Diagnosed Glioblastoma presented by lead investigator Rose K. Lai, M.D.

Cancer Immunotherapy Conference 2011 Presentation - Overview of Celldex’s Precision Targeted Immunotherapy Platform with a focus on rindopepimut (CDX-110) and critical factors in the validity of data for vaccines presented by Thomas Davis, M.D.

Lesniak MS. Immunotherapy for glioblastoma: the devil is in the details. J Clin Oncol. 2011 Aug 1;29(22):3105; author reply 3105-6. Epub 2011 Jun 27.

Sampson JH, Aldape KD, Archer GE, Coan A, Desjardins A, Friedman AH, Friedman HS, Gilbert MR, Herndon JE, McLendon RE, Mitchell DA, Reardon DA, Sawaya R, Schmittling R, Shi W, Vredenburgh JJ, Bigner DD, Heimberger AB. Greater chemotherapy-induced lymphopenia enhances tumor-specific immune responses that eliminate EGFRvIII-expressing tumor cells in patients with glioblastoma. Neuro Oncol. 2011 Mar;13(3):324-33. Epub 2010 Dec 10.

SNO 2010 Poster - Final Analysis of PFR in ACT III: A Phase 2 Trial of Rindopepimut (CDX-110) with Temozolomide in Patients with Newly Diagnosed GBM

Sampson JH, Heimberger AB, Archer GE, Aldape KD, Friedman AH, Friedman HS, Gilbert MR, Herndon JE 2nd, McLendon RE, Mitchell DA, Reardon DA, Sawaya R, Schmittling RJ, Shi W, Vredenburgh JJ, Bigner DD. Immunologic escape after prolonged progression-free survival with epidermal growth factor receptor variant III peptide vaccination in patients with newly diagnosed glioblastoma. J. Clin. Oncology. 2010 Nov 1;28(31):4722-9. Epub 2010 Oct 4.

Lowenstein PR. Cancer vaccines in glioma: how to balance the challenges of small trials, efficiency, and potential adverse events. J Clin Oncol. 2010 Nov 1;28(31):4670-3. Epub 2010 Oct 4.

ASCO 2010 Presentation - Interim Data for ACT III—Phase II Trial of Rindopepimut (PF-04948568, CDX-110) in Combination With Temozolomide (TMZ) in Patients (pts) With Glioblastoma (GBM)

ASCO 2010 Poster - Interim Data for ACT III—Phase II Trial of Rindopepimut (PF-04948568, CDX-110) in Combination With Temozolomide (TMZ) in Patients (pts) With Glioblastoma (GBM)

ASCO 2009 Poster - Epidermal growth factor receptor variant III-targeted vaccine in GBM

Bruce Goldman. An Injection of Hope, Journal of Life Sciences. 2007 1: 56-62.

ASCO 2007 Poster - Temozolomide as a Vaccine Adjuvant in GBM

Pelloski CE, Ballman KV, Furth AF, Zhang L, Lin E, Sulman EP, Bhat K, McDonald JM, Yung WK, Colman H, Woo SY, Heimberger AB, Suki D, Prados MD, Chang SM, Barker FG 2nd, Buckner JC, James CD, Aldape K. Epidermal growth factor receptor variant III status defines clinically distinct subtypes of glioblastoma. J. Clin. Oncology. 2007 Jun 1;25(16):2288-94.

Bruce Goldman. Taming a Mutinous Mutant: An Errant Receptor Becomes a Prime Cancer Target J. Natl. Cancer Inst. 2007 99: 504-505

Heimberger AB, Crotty LE, Archer GE, Hess KR, Wikstrand CJ, Friedman AH, Friedman HS, Bigner DD, Sampson JH. Epidermal growth factor receptor VIII peptide vaccination is efficacious against established intracerebral tumors. Clin. Cancer Res. 2003 9(11):4247-54.

Lorimer IA. Mutant epidermal growth factor receptors as targets for cancer therapy. Curr. Cancer Drug Targets. 2002 2(2):91-102

C-T Kuan, CJ Wikstrand and DD Bigner. EGF mutant receptor vIII as a molecular target in cancer therapy. Endocrine-Related Cancer. 2001 8:83-96.

Moscatello DK, Montgomery RB, Sundareshan P, McDanel H, Wong MY, Wong AJ. Transformational and altered signal transduction by a naturally occurring mutant EGF receptor. Oncogene. 1996 13(1):85-96.

Antibody-Drug Conjugate Programs

SABCS 2012 Poster - A Randomized Phase 2 Study of the Antibody-drug Conjugate CDX-011 in Advanced GPNMB Overexpressing Breast Cancer: The EMERGE study

ASCO 2010 Poster - Frequent Dosing and GPNMB Expression with CDX-011 (CR011-vcMMAE), an Antibody-Drug Conjugate (ADC), in Patients with Advanced Melanoma

ASCO 2010 Poster - Correlation of GPNMB Expression with Outcome in Breast Cancer (BC) Patients Treated with the Antibody-Drug Conjugate (ADC), CDX-011 (CR011-vcMMAE)

SABCS 2009 Poster - A Phase 1/2 Study of CR011-vcMMAE (CDX-011), an Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Breast Cancer

ASCO 2009 Poster - A Phase 1/2 Study of CDX-011, an Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Breast Cancer

ASCO 2009 Poster - Pharmacokinetics of CDX-011, an Antibody-Drug Conjugate, in a Phase 1 Study of Patients with Advanced Melanoma

ASCO 2009 Poster - A Phase 1/2 Study of CDX-011, an Antibody-Drug Conjugate Targeting Glycoprotein NMB in Patients with Advanced Melanoma

iSBTc 2008 Poster - Phase 1/2 Study of CDX-011, an Antibody-Drug Conjugate Targeting GPNMB, for the Treatment of Patients with Advanced Melanoma.

ASCO 2008 Poster - A Phase 1/2 Study of CDX-011, an Antibody-Drug Conjugate, in Patients with Unresectable Stage III or Stage IV Melanoma

AACR 2007 Poster - Phase 1 Pharmacokinetic Study of CDX-011, an Antibody Toxin Conjugate Drug, in Patients with Unresectable Stage III/IV Melanoma

Pollack VA, Alvarez E, Tse KF, Torgov MY, Xie S, Shenoy SG, MacDougall JR, Arrol S, Zhong H, Gerwien RW, Hahne WF, Senter PD, Jeffers ME, Lichenstein HS, LaRochelle WJ. Treatment parameters modulating regression of human melanoma xenografts by an antibody-drug conjugate (CR011-vcMMAE) targeting GPNMB. Cancer Chemother Pharmacol. 2007 Aug;60(3):423-35.

AACR 2006 Poster - CDX-014, a potent fully human monoclonal antibody-monomethylauristatin E-conjugated drug targeting ovarian and renal cell carcinoma

Mesri M, Smithson G, Ghatpande A, Chapoval A, Shenoy S, Boldog F, Hackett C, Pena CE, Burgess C, Bendele A, Shimkets RA, Starling GC. Inhibition of in vitro and in vivo T cell responses by recombinant human Tim-1 extracellular domain proteins. Int Immunol. 2006 Mar;18(3):473-84.

Tse KF, Jeffers M, Pollack VA, McCabe DA, Shadish ML, Khramtsov NV, Hackett CS, Shenoy SG, Kuang B, Boldog FL, MacDougall JR, Rastelli L, Herrmann J, Gallo M, Gazit-Bornstein G, Senter PD, Meyer DL, Lichenstein HS, LaRochelle WJ. CR011, a fully human monoclonal antibody-auristatin E conjugate, for the treatment of melanoma. Clin Cancer Res. 2006 Feb 15;12(4):1373-82.

APC Targeting Vaccine Reviews

Morse MA, Chapman R, Powderly J, Blackwell K, Keler T, Green J, Riggs R, He LZ, Ramakrishna V, Vitale L, Zhao B, Butler SA, Hobeika A, Osada T, Davis T, Clay T, Lyerly HK. Phase I study utilizing a novel antigen-presenting cell-targeted vaccine with Toll-like receptor stimulation to induce immunity to self-antigens in cancer patients.., Clin Cancer Res. 2011: Jul 15; 17(14): 4844-53.

Francisca A. Neethling, Venky Ramakrishna, Tibor Keler, Rico Buchli, Jon A. Weidanz; Assessing vaccine potency using TCRmimic Antibodies, Vaccine. vol. 26 (14) 2008

Keler T, He L, Ramakrishna V, Champion B., Antibody-targeted vaccines. Oncogene. 2007 May 28;26(25):3758-67.

APC Targeting: Mannose Receptor

Tsuji T, Matsuzaki J, Kelly MP, Ramakrishna V, Vitale L, He LZ, Keler T, Odunsi K, Old LJ, Ritter G, Gnjatic S. Antibody-targeted NY-ESO-1 to mannose receptor or DEC-205 in vitro elicits dual human CD8+ and CD4+ T cell responses with broad antigen specificity. J Immunol. 2011 Jan 15;186(2):1218-27.

ASCO 2010 Poster - A Randomized Phase II Study of a Novel Antigen-Presenting Cell-Targeted hCG-β Vaccine (The CDX-1307 Regimen) in Muscle-Invasive Bladder Cancer

iSBTc 2009 Poster - A Clinical Study Combining Multiple Immune Modulators and an APC-Targeted hCG-β Vaccine (CDX-1307)

ASCO 2009 Presentation – Phase 1 clinical results of an APC-targeted hCG-β vaccine (CDX-1307) with TLR agonists

iSBTc 2008 Poster - Phase 1 Clinical Results Comparing Local and Systemic Administration of an APC-Targeted Cancer Vaccine

ASCO 2007 Poster – APC-targeted hCG-β vaccine for Cancer Therapy

Venky Ramakrishna*, John P Vasilakos, Joseph D Tario Jr, Marc A Berger, Paul K Wallace and Tibor Keler. Toll-like receptor activation enhances cell-mediated immunity induced by an antibody vaccine targeting human dendritic cells. Journal of Translational Medicine. 2007, 5:5

Li-Zhen He, Andrea Crocker, Janine Lee, Jose Mendoza-Ramirez, Xi-Tao Wang, Laura A. Vitale, Thomas O’Neill, Chris Petromilli, Hui-Fen Zhang, Joe Lopez, Dan Rohrer, Tibor Keler, and Raphael Clynes. Antigenic Targeting of the Human Mannose Receptor Induces Tumor Immunity. The Journal of Immunology, 2007, 178: 6259 – 6267.

He L, Ramakrishna V, Connolly JE, Wang XT, Smith PA, Jones CL, Valkova-Vachnova M, Arunakumari A, Treml JF, Goldstein J, Wallace PK, Keler T and Endres MJ. A novel human cancer vaccine elicits cellular responses to the tumor-associated antigen, human chorionic gonadotropin γ. Clinical Cancer Research. 2004 10 (6).

Keler T, Ramakrishna V, Fanger MW. Mannose receptor-targeted vaccines. Expert Opin Biol Ther. 2004 4(12):1953-62.

Ramakrishna V, Treml JF, Vitale L, Connolly JE, O'Neill T, Smith P, Jones CL, He L, Goldstein J, Wallace PK, Keler T, and Endres MJ. Mannose receptor targeting of tumor antigen pmel17 to human dendritic cells directs anti-melanoma T cell responses via multiple HLA molecules. J. Immunol. 2004 172(5):2845-52.

Wallace P. K., K. Y. Tsang, J. Goldstein, P. Correale, T. M. Jarry, J. Schlom, P. M. Guyre, M. S. Ernstoff, and M. W. Fanger. Exogenous antigen targeted to FcγRI on myeloid cells is presented in association with MHC class I. J. Immunol. Methods. 2001 248:183.

Guyre CA, Keler T, Swink SL, Vitale LA, Graziano RF, Fanger MW. Receptor modulation by FcγRI-specific fusion proteins is dependent on receptor number and modified by IgG. J. Immunol. 2000 167:6303-11.

Keler T, Guyre PM, Vitale LA, Sundarapandiyan K, van de Winkel JGJ, Deo YM, et al. Targeting weak antigens to CD64 elicits potent humoral responses in human CD64 transgenic mice. J. Immunol. 2000 165(12):6738-42.

van Vugt MJ, Kleijmeer MJ, Keler T, Zeelenberg I, van Dijk MA, Geuze HJ, et al. The FcγRIa (CD64) ligand binding chain triggers MHC class II antigen presentation independently of its associated FcR γ-chain. Blood. 1999 94(2):808-17

Fanger, N. A., D. Voigtlaender, C. Liu, S. Swink, K. Wardwell, J. Fisher, R. F. Graziano, L. C. Pfefferkorn, and P. M. Guyre. Characterization of expression, cytokine regulation, and effector function of the high affinity IgG receptor FcγRI (CD64) expressed on human Blood DCs. J. Immunol. 1997 158:3090.

Wallace PK, Keler T, Guyre PM, Fanger MW. FcγRI blockade and modulation for immunotherapy. Cancer Immunol. Immunotherapy. 1997 45:137-141.

Heijnen, I. A., M. J. van Vugt, N. A. Fanger, R. F. Graziano, T. P. de Wit, F. M. Hofhuis, P. M. Guyre, P. J. Capel, J. S. Verbeek, and J. G. van de Winkel. Antigen targeting to myeloid-specific human FcγRI/CD64 triggers enhanced antibody responses in transgenic mice. J. Clin.Invest. 1996 97:331.

Liu, C., J. Goldstein, R. F. Graziano, J. He, J. K. O'Shea, Y. Deo, and P. M. Guyre. FcγRI-targeted fusion proteins result in efficient presentation by human monocytes of antigenic and antagonist T-cell epitopes. J. Clin. Invest. 1996 98:2001.

Graziano, R. F., P. R. Tempest, P. White, T. Keler, Y. Deo, H. Ghebremariam, K. Coleman, L. C. Pfefferkorn, M. W. Fanger, and P.M. Guyre. Construction and characterization of a humanized anti-γ-Ig receptor type I (FcγRI) monoclonal antibody. J. Immunol. 1995 155:4996.

Guyre, P. M., Graziano R.F., Vance B.A., P. M. Morganelli, and M. W. Fanger. Monoclonal antibodies that bind to distinct epitopes of FcγR are able to trigger receptor function. J. Immunol. 1989 143:1650.

Gosselin, E. J., K. Wardwell, D. R. Gosselin, N. Alter, J. L. Fisher, and P. M. Guyre. Enhanced antigen presentation using human Fcγ receptor (monocyte/macrophage)-specific immunogens. J. Immunol. 1982 149:3477.

APC Targeting: DEC-205

SITC 2012 Poster - A Phase 1 Trial of a Novel Vaccine Targeting NY-ESO-1 to the Dendritic Cell Receptor DEC-205 in Combination with Toll-like Receptor Agonists

Tsuji T, Matsuzaki J, Kelly MP, Ramakrishna V, Vitale L, He LZ, Keler T, Odunsi K, Old LJ, Ritter G, Gnjatic S. Antibody-targeted NY-ESO-1 to mannose receptor or DEC-205 in vitro elicits dual human CD8+ and CD4+ T cell responses with broad antigen specificity. J Immunol. 2011 Jan 15;186(2):1218-27.

iSBTc 2010 Poster - Early Development of CDX-1401, A Novel Vaccine Targeting NY-ESO-1 to the Dendritic Cell Receptor DEC-205, in Combination with Toll-like Receptor Agonists

Bozzacco L, Trumpfheller C, Huang Y, Longhi MP, Shimeliovich I, Schauer JD, Park CG, Steinman RM, HIV gag protein is efficiently cross-presented when targeted with an antibody towards the DEC-205 receptor in Flt3 ligand-mobilized murine DC. Eur J Immunol. 2010 Jan;40(1):36-46.

Ramakrishna V, Tsujit T, Cohen L, Vitale L, O’Neill, Sundarapandiyan K, Gnjatic S, Ritter G and Keler T. Cross presentation of NY-ESO-1 to T cells by professional and non-professional APCs via a common DEC-205 receptor. Cancer Immunology & Immunotherapy - Realizing the Promise; Sep. 11-12, 2008. NIH Bethesda MD.

Bozzacco L, Trumpfheller C, Siegal FP, Mehandru S, Markowitz M, Carrington M, Nussenzweig MC, Piperno AG, Steinman RM, DEC-205 receptor on dendritic cells mediates presentation of HIV gag protein to CD8+ T cells in a spectrum of human MHC I haplotypes. Proc Natl Acad Sci U S A. 2007 Jan 23;104(4):1289-94. Epub 2007 Jan 17.

Mahnke K, Qian Y, Fondel S, Brueck J, Becker C, Enk AH. Targeting of antigens to activated dendritic cells in vivo cures metastatic melanoma in mice. Cancer Res. 2005 65(15):7007-12.

Bonifaz LC, Bonnyay DP, Charalambous A, Darguste DI, Fujii S, Soares H, Brimnes MK, Moltedo B, Moran TM, Steinman RM: In vivo targeting of antigens to maturing dendritic cells via the DEC-205 receptor improves T cell vaccination. J. Exp. Med. 2004 199:815-824.

Bonifaz L, Bonnyay D, Mahnke K, Rivera M, Nussenzweig MC, Steinman RM: Efficient targeting of protein antigen to the dendritic cell receptor DEC-205 in the steady state leads to antigen presentation on major histocompatibility complex class I products and peripheral CD8+ T cell tolerance J. Exp. Med. 2002 196:1627-1638.

Hawiger D, Inaba K, Dorsett Y, Guo M, Mahnke K, Rivera M, Ravetch JV, Steinman RM, Nussenzweig MC: Dendritic cells induce peripheral T cell unresponsiveness under steady state conditions in vivo. J. Exp. Med. 2001 194:769-779.

Guo M, Gong S, Maric S, Misulovin Z, Pack M, Mahnke K, Nussenzweig MC, Steinman RM: A monoclonal antibody to the DEC-205 endocytosis receptor on human dendritic cells. Hum. Immunol. 2000 61:729-738.

Mahnke K, Guo M, Lee S, Sepulveda H, Swain SL, Nussenzweig M, Steinman RM: The dendritic cell receptor for endocytosis, DEC-205, can recycle and enhance antigen presentation via major histocompatibility complex class II-positive lysosomal compartments. J. Cell Biol. 2000 151:673-684.

Jiang, W., W.J. Swiggard, C. Heufler, M. Peng, A. Mirza, R.M. Steinman, and M.C. Nussenzweig. The receptor DEC-205 expressed by dendritic cells and thymic epithelial cells is involved in antigen processing. Nature. 1995 375:151-155.

Witmer-Pack, M.D., W.J. Swiggard, A. Mirza, K. Inaba, and R.M. Steinman. Tissue distribution of the DEC-205 protein that is detected by the monoclonal antibody NLDC-145. II. Expression in situ in lymphoid and nonlymphoid tissues. Cell. Immunol. 1995 163:157-162.

Human Monoclonal Antibody Programs: CD27

AACR 2013 Poster - Characterization of the Response of Human T cells to an Agonist Human Anti-CD27 mAb

Vitale LA, He LZ, Thomas LJ, Widger J, Weidlick J, Crocker A, O'Neill T, Storey J, Glennie MJ, Grote DM, Ansell SM, Marsh H, Keler T. Development of a Human Monoclonal Antibody for Potential Therapy of CD27-Expressing Lymphoma and Leukemia. Clin Cancer Res. 2012 Jun 21.; 1-10.

AACR 2012 Poster - Appropriate cross-linking is required for co-stimulatory activity of human anti-CD27 antibody in a transgenic mouse model

ASH 2011 Poster - Development of a Human Anti-CD27 Antibody with Efficacy in Lymphoma and Leukemia Models by Two Distinct Mechanisms

AACR 2011 Poster - Anti-Tumor Activity of a Fully Human anti-CD27 Monoclonal Antibody in a Transgenic Mouse Model

AACR 2010 Poster - Development of Novel Anti-CD27 Human Antibodies with Therapeutic Potential

Ramakrishna V., Vitale L, Sundarapandiyan K, Zhao B, Crocker A, Widger J. et al. In vitro characterization of novel anti-human CD27 (TNFRSF7) mAbs. 97th Annual Meeting AAI Immunology May 7-11, 2010, Baltimore MD.

French, R. R., V. Y. Taraban, G. R. Crowther, T. F. Rowley, J. C. Gray, P. W. Johnson, A. L. Tutt, A. Al-Shamkhani, and M. J. Glennie. 2007. Eradication of lymphoma by CD8 T cells following anti-CD40 monoclonal antibody therapy is critically dependent on CD27 costimulation. Blood 109:4810-4815.

Human Monoclonal Antibody Programs: CD89

Deo, Y. M., K. Sundarapandiyan, T. Keler, P. K. Wallace, and R. F. Graziano. 1998. Bispecific molecules directed to the Fc receptor for IgA (Fc alpha RI, CD89) and tumor antigens efficiently promote cell-mediated cytotoxicity of tumor targets in whole blood. J. Immunol. 160:1677-1686.

Kanamaru, Y., S. Pfirsch, M. Aloulou, F. Vrtovsnik, M. Essig, C. Loirat, G. Deschenes, C. Guerin-Marchand, U. Blank, and R. C. Monteiro. 2008. Inhibitory ITAM signaling by Fc alpha RI-FcR gamma chain controls multiple activating responses and prevents renal inflammation. J. Immunol. 180:2669-2678.

Immune Modulators (Flt3L)

ASH 2012 Poster - A Phase 1 Trial of the Hematopoietic Growth Factor CDX-301 (rhuFlt3L) in Healthy Volunteers

Maraskovsky, E., E. Daro, E. Roux, M. Teepe, C. R. Maliszewski, J. Hoek, D. Caron, M. E. Lebsack, and H. J. McKenna. 2000. In vivo generation of human dendritic cell subsets by Flt3 ligand. Blood 96:878-884.

Sitnicka, E., N. Buza-Vidas, S. Larsson, J. M. Nygren, K. Liuba, and S. E. Jacobsen. 2003. Human CD34+ hematopoietic stem cells capable of multilineage engrafting NOD/SCID mice express flt3: distinct flt3 and c-kit expression and response patterns on mouse and candidate human hematopoietic stem cells. Blood 102:881-886.

Higano, C. S., N. J. Vogelzang, J. A. Sosman, A. Feng, D. Caron, and E. J. Small. 2004. Safety and biological activity of repeated doses of recombinant human Flt3 ligand in patients with bone scan-negative hormone-refractory prostate cancer. Clin Cancer Res 10:1219-1225.

Fong, L., Y. Hou, A. Rivas, C. Benike, A. Yuen, G. A. Fisher, M. M. Davis, and E. G. Engleman. 2001. Altered peptide ligand vaccination with Flt3 ligand expanded dendritic cells for tumor immunotherapy. Proceedings of the National Academy of Sciences of the United States of America 98:8809-8814.

Bohannon, J., W. Cui, R. Cox, R. Przkora, E. Sherwood, and T. Toliver-Kinsky. 2008. Prophylactic treatment with fms-like tyrosine kinase-3 ligand after burn injury enhances global immune responses to infection. J Immunol 180:3038-3048.

Wodnar-Filipowicz, A. 2003. Flt3 ligand: role in control of hematopoietic and immune functions of the bone marrow. News Physiol Sci 18:247-251.

Complement Inhibitor (sCR1, CDX-1135, TP10)

Pierson, R. N., 3rd, Loyd, J. E., Goodwin, A., Majors, D., Dummer, J. S., Mohacsi, P., Wheeler, A., Bovin, N., Miller, G. G., Olson, S., Johnson, J., Rieben, R., and Azimzadeh, A. (2002) Successful management of an ABO-mismatched lung allograft using antigen-specific immunoadsorption, complement inhibition, and immunomodulatory therapy, Transplantation 74, 79-84.

Lazar HL, Bokesch PM, Van Lenta F, Fitzgerald C, Emmett C, Marsh HC, Jr., Ryan U. 2004. Soluble human complement receptor 1 limits ischemic damage in cardiac surgery patients at high risk requiring cardiopulmonary bypass. Circulation 110 (11 Suppl 1):II274-II279.

Lazar HL, Keilani T, Fitzgerald CA, et al. Beneficial effects of complement inhibition with soluble complement receptor 1 (TP10) during cardiac surgery: is there a gender difference? Circulation 2007; 116 (11 Suppl): I83.

Li JS, Jaggers J, Anderson PAW. 2006. The use of TP10, soluble complement receptor 1, in cardiopulmonary bypass. Expert Rev. Cardiovasc. Ther. 4(5):649-654.

Li JS, Sanders SP, Perry AE, Stinnett SS, Jaggers J, Bokesch P, Reynolds L, Nassar R, Anderson PA. 2004. Pharmacokinetics and safety of TP10, soluble complement receptor 1, in infants undergoing cardiopulmonary bypass. Am. Heart J. 147(1):173-80.

Keshavjee, S., Davis, R. D., Zamora, M. R., de Perrot, M., and Patterson, G. A. (2005) A randomized, placebo-controlled trial of complement inhibition in ischemia-reperfusion injury after lung transplantation in human beings, J. Thorac. Cardiovasc. Surg. 129, 423-428.

Couser WG, Johnson RJ, Young BA, Yeh CG, Toth CA, Rudolph AR. 1995. The effects of soluble recombinant complement receptor 1 on complement-mediated experimental glomerulonephritis. J. Amer. Soc. Nephrol. 5(11):1888-1894.

Kondo, C, Mizuno M, Nishikawa K, Yuzawa Y, Hotta N, Matsuo .S. 2001. The role of C5a in the development of thrombotic glomerulonephritis in rats. Clin. Exp. Immunol. 124:323-329.

Morita Y, Nomura A, Yuzawa Nishikawa K, Hotta N, Shimizu F, Matsuo S. 1997. The role of complement in the pathogenesis of tubulointerstitial lesions in rat mesangial proliferative glomerulonephritis. J. Am. Soc. Nephrol. 8: 1363-1372.

Mosley K, Waddington SN, Ebrahim H, Cook T, Cattell V. 1999. Inducible nitric oxide synthase induction in Thy 1 glomerulonephritis is complement and reactive oxygen species dependent. Exp. Nephrol. 7(1):26-34.

Notch Binding Proteins

Briend, E. Young LL, McKenzie GJ, Tugal T, Ragno S, & Champion BR. Modulation of the notch pathway for immunotherapy. Curr. Opin. Mol. Ther. 2005 7(1): 56-61.

Dallman, M.J., Smith E, Benson RA & Lamb JR. Notch: control of lymphocyte differentiation in the periphery. Curr. Opin. Immunol. 2005 17(3): 259-66.

McKenzie, G. J., M. Khan, Briend E, Stallwood Y & Champion B.R. Notch: a unique therapeutic target for immunomodulation. Expert Opin. Ther. Targets. 2005 9(2): 395-410.

Mckenzie GJ, Young LL, Briend E, Lamb JR, Dallman MJ, & Champion B.R. Notch signalling in the regulation of peripheral T cell function. Semin. Cell Dev. Biol. 2003 14(2):127-34.

Wong KK, Carpenter MJ, Young LL, Walker SJ, McKenzie G, Rust AJ, Ward G, Packwood L, Wahl K, Delriviere L, Hoyne G, Gibbs P, Champion BR, Lamb JR, Dallman MJ. Notch ligation by Delta1 inhibits peripheral immune responses to transplantation antigens by a CD8+ cell-dependent mechanism. J. Clin. Invest. 2003 112(11):1741-50.

Hoyne GF, Dallman MJ, Champion BR, & Lamb JR. Notch signalling in the regulation of peripheral immunity. Immunol. Rev. 2001 182:215-27.

Hoyne, Le Roux, Corsin-Jimenez, Tan, Dunne, Forsyth, Dallman, Owen, Ish-Horowicz, Lamb. Serrate1-induced notch signalling regulates the decision between immunity and tolerance made by peripheral CD4(+) T cells. Int. Immunol. 2000 12(2):177-85.