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Vaccine Abstracts

  1. Greene JM, Schneble EJ, Martin J, Flores M, Berry JS, Trappey AT, Vreeland TJ, Hale DF, Sears AK, Clifton GT, von Hofe E, Symanowski JT, Ardavanis A, Shumway NM, Ponniah S, Papamichail M, Perez SA, Peoples GE, Mittendorf EA. Final pre-specified analysis of the phase II trial of the AE37+GM-CSF vaccine in high risk breast cancer patients to prevent recurrence. J Clin Oncol 1015,33(suppl; abstr 622).
  2. Greene JM, Schneble EJ, Berry JS, Trappey AF, Vreeland TJ, Clifton GT, McGuire WP, Maxwell GL, Ponniah S, Peoples GE. Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine (E39+GM-CSF) in ovarian and endometrial cancer patients to prevent recurrence. J Clin Oncol 2015,33(suppl; abstr e14031).
  3. Greene JM, Schneble EJ, Berry IV JS, Trappey III AF , Vreeland TJ, Clifton GT, McGuire WP, Maxwell GL, Ponniah S, Peoples GE. Preliminary Results of the Phase I/IIa Dose Finding Trial of a Folate Binding Protein Vaccine (E39+GM-CSF) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence. J Clin Oncol 2015,33 (suppl; abstr e14031).
  4. Greene, JM, Schneble EJ, Litton JK, Martin J, Trappey AF, Berry JS, Vreeland TJ, Hale DF, Clifton GT, Ardavannis A, Papamichail M, Perez S, Ponniah S, Mittendorf EA, Peoples GE. Correlation of robust local reactions prompting GM-CSF dose reduction to clinical response in a phase II trial of the AE37+GM-CSF HER2 peptide vaccine. AACR 2015 Poster. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; 2015. Abstract nr CT209.
  5. Mittendorf EA, Schneble EJ, Ibrahim N, Greene J, Berry JS, Trappey AF, Clifton GT, Holmes JP, Ponniah S, Peoples GE . Combination immunotherapy with trastuzumab and the HER2 vaccine E75 (nelipepimut-S) in high-risk HER2+ breast cancer patients to prevent recurrence. Cancer Res 2015;75(9 Suppl),OT3-1-09
  6. Greene JM, Schneble EJ, Martin J, Flores M, Trappey AF, Berry JS, Vreeland TJ, Hale DF, Clifton GT, Papamichail M, Perez S, Peoples GE, Mittendorf EA, Ponniah S. Correlation of HER2/neu Antibody Response to Clinical Response in a Phase II Trial of the AE37+GM-CSF HER2 Peptide Vaccine. Journal for ImmunoTherapy of Cancer 2014, 2(suppl 3):P90.
  7. Greene JM, Schneble EJ, Berry JS, Trappey AF, Vreeland TJ, Clifton GT, McGuire WP, Maxwell GL, Ponniah S, and Peoples GE. Preliminary Results of the Phase IIa Trial of a Folate Binding Protein (FBP) Adjuvant Cancer Vaccine (E39+GM-CSF) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence.   Journal for ImmunoTherapy of Cancer 2014, 2(suppl 3):P74.
  8. Schneble EJ, Berry JS, Trappey AF, Vreeland TJ, Clifton GT, Ponniah S, Perez SA, Papamichail M, Peoples GE, Mittendorf EA. The clinical benefit and safety of boosting the HER2-peptide vaccine (AE37+GM-CSF) in the adjuvant setting to prevent breast cancer recurrence. J Am Coll Surg 2014; 219 (suppl e170).
  9. Schneble EJ, Berry JS, Trappey AF, Vreeland TJ, Clifton GT, von Hofe E, Ardavannis A, Shumway N, Ponniah S, Papamichail M, Perez S, Mittendorf EA, Peoples GE. Biomarker correlation to clinical response in a phase II trial of the HER2 peptide vaccine (AE37+GM-CSF). J Am Coll Surg 2014; 219:4 (suppl e47).
  10. Mittendorf EA, Schneble EJ, Perez S, Symanowski JT, Patil R, Vreeland TJ, Berry JS, Trappey AF, Hale DF, Sears AK, Clifton GT, von Hofe E, Ardavannis A, Ponniah S, Shumway N, Papamichail M, Peoples GE. Primary analysis of the prospective, randomized, single-blinded phase II trial of AE37 vaccine vs GM-CSF alone administered in the adjuvant setting to high risk breast cancer patients. J Clin Oncol 2014; 32:5s (suppl: abstr 638).
  11. Schneble EJ, Byrd KA, Vreeland T, Berry JS, Trappey AF, Clifton GT, Ponniah S, Mittendorf EA, McGuire WP, Conrads TP, Darcy KM, Maxwell GL, Hamilton CA, Elkas JC, Peoples GE. Comparison of recurrent and non-recurrent ovarian and uterine cancer patients undergoing adjuvant folate receptor vaccine therapy. J Clin Oncol 2014; 32:5s (suppl: abstr 5559).
  12. Schneble EJ, Perez S, Berry JS, Trappey AF, Vreeland TJ, Hale DF, Sears AK, Clifton GT, von Hofe E, Ardavannis A, Shumway N, Ponniah S, Papamichail M, Peoples GE, Mittendorf EA. Comparison of recurrent and non-recurrent breast cancer patients undergoing AE37 peptide vaccine therapy. J Clin Oncol 2014 (In Press).
  13. Schneble EJ, Trappey AF, Berry JS, Vreeland TJ, Hale DF, Sears AK, Clifton GT, Ponniah S, Mittendorf EA, Peoples GE. HLA-A2 and HER2 expression levels as clinical prognostic factors in breast cancer patients: Implications for peptide cancer vaccine trials. Cancer Res 2014; 74 (In Press).
  14. Schneble EJ, Trappey AF, Berry JS, Vreeland TJ, Hale DF, Sears AK, Clifton GT, Ponniah S, Mittendorf EA, Peoples GE. Immunologic effects of a HER2 peptide (GP2) vaccine booster in previously vaccinated breast cancer patients. Cancer Res 2014; 74 (Suppl 19; abst 2899).
  15. Schneble E, Berry JS, Trappey AF, Hale DF, Vreeland TJ, Sears A, Clifton GT, Ponniah S, Papamichail M, Perez S, Peoples GE, Mittendorf E. The clinical benefit and safety of boosting the HER2 peptide vaccine (GP2+GM-CSF) in the adjuvant setting to prevent breast cancer recurrence. Ann Surg Oncol 2014;21 (Suppl 1):S45, P6.
  16. Trappey A, Berry JS, Schneble E, Aden J, Vreeland TJ, Hale DF, Sears A, Brown R, Perez S, Clifton GT, Papamichail M, Ponniah S, Mittendorf E, Peoples GE. Induced immunity correlates with and may predict clinical benefit in the phase II clinical trial of the anti-HER2 (GP2) vaccine to prevent recurrence in high-risk breast cancer patients. Ann Surg Oncol 2014;21 (Suppl 1):S11, 16.
  17. Berry JS, Trappey AF, Vreeland TJ, Schneble EJ, Clifton GT, Hale DF, Sears AK, Ponniah S, Shumway NM, Mittendorf EA, Peoples GE. Preliminary results for the phase I trial of a dual HER2 peptide cancer vaccine in breast and ovarian cancer patients. Cancer Res 2013;73:P4-13-02.
  18. Trappey AF, Berry JS, Vreeland TJ, Guy CT, Diane HF, Alan SK, Erika SJ, Ferrise L, Shumway NM, Papamichail M, Perez SA, Ponniah S, Mittendorf EA, Peoples GE. HLA-A2 is not a prognostic indicator in breast cancer: Implications for cancer vaccine trials. Cancer Res 2013;73:P4-13-05.
  19. Schneble EJ, Berry JS, Trappey AF, Vreeland TJ, Hale DF, Sears AK, Clifton GT, Ponniah S, Shumway NM, Mittendorf EA, Peoples GE. Vaccine-specific T-cell proliferation in response to a dual peptide cancer vaccine in breast and ovarian cancer patients. J Immunother Cancer 2013;1 (Suppl 1):P236.
  20. Berry JS, Schneble EJ, Trappey AF, Vreeland TJ, Clifton GT, Hale DF, Sears AK, Ponniah S, Mittendorf EA, Peoples GE. Preliminary results for the phase I trial of a folate receptor alpha adjuvant cancer vaccine in ovarian and endometrial cancer patients. J Immunother Cancer 2013;1 (Suppl 1):P200.
  21. Trappey AF, Berry JS, Mursal M, Jama Y, Zacharia A, Pham R, Margulies E, Ponniah S, Mittendorf EA, Peoples GE. Identification of a regulatory T cell subset that correlates with in vivo and in vitro immune responses in breast cancer patients receiving a CD4-eliciting, HER2 peptide vaccine (AE37). J Am Coll Surg 2013;217(3)( Supplement September 2013):S134.
  22. Berry JS, Trappey AF, Sears AK, Vreeland TJ, Clifton GT, Hale DF, Patil R, Holmes JP, Ponniah S, Mittendorf EA, Peoples GE, Van Echo DC. Biomarker correlation to clinical response in phase I/II trials of the adjuvant breast cancer vaccine neuvax (nelipepimut-S or E75). J Clin Oncol 31(15)(May 20 Suppl);2013:TPS3126.
  23. Trappey F, Berry JS, Vreeland TJ, Hale DF, Sears AK, Ponniah S, Perez SA, Clifton GT, Papamichail M, Peoples GE, Mittendorf EA. Randomized phase II clinical trial of the anti-HER2 (GP2) vaccine to prevent recurrence in high-risk breast cancer patients: A planned interim analysis. J Clin Oncol 31(15)(May 20 Suppl);2013: 3005.
  24. Trappey AF, Berry JS, Vreeland TJ, Hale DF, Sears AK, Ponniah S, Perez SA, Clifton GT, Papamichail M, Shumway NM, Mittendorf EA, Peoples GE. Risk factors for development of delayed urticarial reactions in the phase II trial of HER2 peptide vaccines plus GM-CSF versus GM-CSF alone in high-risk breast cancer patients to prevent recurrence. J Clin Oncol 31(15)(May 20 Suppl);2013:3097.
  25. Patil R, Clifton GT, Litton JK, Shumway NM, Vreeland TJ, Berry JS, Trappey AF, Ponniah S, Peoples GE, Mittendorf EA. Safety and efficacy of the HER2-derived GP2 peptide vaccine in combination with trastuzumab for breast cancer patients in the adjuvant setting. J Clin Oncol 31(15)(May 20 Suppl);2013:3096
  26. Trappey AF, Berry JS, Vreeland TJ, Hale DF, Sears AK, Clifton G, Ponniah S, Papamichail M, Perez SA, Mittendorf E, Peoples GE. Delayed urticarial reactions in the phase II trial of HER2/neu peptide vaccines + GM-CSF vs. GM-CSF alone in high risk breast cancer patients. Cancer Res 2013;73:4670.
  27. Berry JS, Trappey AF, Vreeland TJ, Hale DF, Clifton GT, Sears AK, Shumway NM, Ponniah S, Holmes JP, Ioannides C, Mittendorf EA, Peoples GE. Use of an attenuated version of a strongly immunogenic, peptide-based vaccine to enhance an anti-cancer immune response against folate receptor-alpha. Cancer Res 2013;73:1251.
  28. Vreeland TJ, Berry JS, Trappey AF, Hale D, Clifton GT, Sears A, Shumway NM, Holmes JP, Ponniah S, Mittendorf EA, Ioannides CG, Peoples GE. Use of an attenuated version of a strongly immunogenic, peptide-based vaccine to enhance an anti-cancer immune response agains folate receptor-a (FRa). Ann Surg Oncol 2013;20 (Suppl 1):S59, P67.
  29. Berry J, Vreeland T, Hale D, Sears A, Dabney RS, Ponniah S, Perez SA, Clifton GT, Hintz C, Covelli JD, Papamichail M, Peoples GE, Mittendorf EA. Factors associated with recurrence in breast cancer patients vaccinated with the HER2-derived GP2 vaccine. Ann Surg Oncol 2013;20 (Suppl 1):S59, P66.
  30. Trappey AF, Vreeland T, Clifton G, Sears A, Clive K, Ferrise S, Saenger JS, Kirkpatrick AD, Lallemand M, Peoples GE. Pure flat epithelial atypia (PFEA): Excise or observe. Ann Surg Oncol 2013; 20 (Suppl 1):S4, P25.
  31. Hale DF, Vreeland TJ, Perez SA, Berry JS, Ardavanis A, Trappey AF, Tzonis P, Sears AK, Clifton GT, Shumway NM, Papamichail M, Ponniah S, Peoples GE, Mittendorf EA. The combination of trastuzumab and HER2-directed peptide vaccines is safe in HER2-expressing breast cancer patients. Cancer Res 2012;72(24 Suppl.) #P5-16-05.
  32. Vreeland TJ, Clifton GT, Hale DF, Sears AK, Patil R, Holmes JP, Ponniah S, Mittendorf EA, Peoples GE. Final results of the phase I/II trials of the E75 adjuvant breast cancer vaccine. Cancer Res 2012;72(24 Suppl.) #P5-16-02.
  33. Hale DF, Perez S, Vreeland TJ, Dabney R, Papamichail M, Clifton GT, Sears A, Ponniah S, Peoples GE, Mittendorf EA. Assessment of disease features and immune response in breast cancer patients with recurrence after receiving AE37, a HER2 peptide vaccine. J Am Coll Surg 2012 (In Press).
  34. Mittendorf EA, Perez SA, Hale DF, Vreeland TJ, Sears AK, Clifton GT, Ardavanis A, Shumway NM, Murray JL, Ponniah S, Papamichail M, Peoples GE. Early efficacy analysis of the AE37 vaccine in patients with HER2 low-expressing and triple-negative breast cancer. J Clin Oncol 30, 2012 (Suppl 27; abstr 109).
  35. Vreeland TJ, Hale DF, Sears AK, Clifton GT, Pappou E, Dabney RS, Ardavanis A, Patil R, Ponniah S, Anastasopoulou E, Perez SA, Papamichail M, Shumway NM, Peoples GE, Mittendorf EA. From bench to bedside: the use of the Ii-Key technology to improve helper peptides for clinical use in cancer vaccines. Journal of Clinical Oncology, 2012 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 30, No 15_suppl (May 20 Supplement), 2012: 2508
  36. Hale DF, Perez SA, Vreeland TJ, Trappey AF, Dabney RS, Berry JS, Ardavanis A, Sears AK, Papamichail M, Clifton GT, Pappou E, Patil R, Anastasopoulou E, Ponniah S, Shumway NM, Peoples GE, Mittendorf EA. An assessment of disease features and immune response in breast cancer patients that did not recur after receiving HER2 peptide, AE37 vaccine in a randomized phase II trial. Journal of Clinical Oncology, 2012 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 30, No 15_suppl (May 20 Supplement), 2012: 625
  37. Dabney RS, Hale DF, Vreeland TJ, Clifton GT, Sears AK, Patil R, Ponniah S, Shumway NM, Peoples GE, Mittendorf EA. Safety and long-term efficacy of booster inculcations with the E75 peptide vaccine in HER2/neu-expressing breast cancer patients. Journal of Clinical Oncology, 2012 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 30, No 15_suppl (May 20 Supplement), 2012: 2529
  38. Vreeland TJ, Dabney RS, Hale DF,  Sears AK, Clifton GT, Zacharia A, Jama Y, Chiplis A, Mursal M, Shumway NM, Patil R, Holmes JP, Peoples GE, Ponniah S, Mittendorf EA. Immune reconstitution after chemotherapy correlates with increased in vitro immune response in breast cancer patients undergoing peptide vaccine therapy. Proc Am Assoc Cancer Res 2012 #LB-130/6.
  39. Hale DF,  Vreeland TJ,  Dabney RS,  Clifton GT,  Sears AK, Pappou E, Anastasopoulou E, Ardavanis A, Ponniah S, Papamichail M, Perez S, Shumway N, Peoples GE, Mittendorf EA. Immune response assessment in a phase II trial of AE37 HER2 peptide vaccine. Proc Am Assoc Cancer Res 2012 #LB-218/3.
  40. Vreeland TJ, Hale DF, Clifton GT, Sears AK, Perez SA, Ardavanis A, Pistamaltzian N, Rellias G, Ponniah S, Papamichail M, Peoples GE, Mittendorf EA. Booster inoculations safely sustain the immune effects of a CD4-targeted peptide cancer vaccine. Ann Surg Oncol 2012;19:#P98.
  41. Sears AK, Clifton GT, Vreeland TJ, Hale DF, Ponniah S, Mittendorf EA, Peoples GE. Combination immunotherapy with trastuzumab and the HER2 vaccine E75 in low and intermediate HER2-expressing breast cancer patients to prevent recurrence. Cancer Res 2011 #OT3-01-18.
  42. Vreeland TJ, Clifton GT, Sears AK, Hale DF, Patil R, Clive KS, Holmes JP, Mittendorf EA, Ponniah S, Peoples GE. Long-term clinical benefit of adjuvant breast cancer vaccine: 5 year efficacy of E75 with multiple booster inoculations. Cancer Res 2011 #P1-13-02.
  43. Hale DF, Perez SA, Sears AK, Clifton GT, Vreeland TJ, Holmes JP, Ardavanis A, Pistamaltzian N, Rellias G, Ponniah S, Papamichail M, Peoples GE, Mittendorf EA. An update of a phase II trial of the HER2 peptide AE37 vaccine in breast cancer patients to prevent recurrence. Cancer Res 2011 #P1-13-01.
  44. Sears AK, Clifton GT, Vreeland TJ, Hale DF, Holmes JP, Patil R, Ponniah S, Mittendorf EA, Peoples GE. Vaccination with the HER2-derived E75 peptide vaccine in breast cancer patients may confer greater benefit to patients with less aggressive disease. J Immunother 2011;34(9), November-December 2011.
  45. Sears AK, Clifton GT, Benavides LC, Gates JD, Holmes JP, Perez S, Ponniah S, Papamichail M, Peoples GE, Mittendorf EA. The relationship between immunologic response and recurrence in a phase II trial evaluating the HER-2/neu peptide vaccines AE37 and GP2 in breast cancer patients in the adjuvant settings. J Am Coll Surg Vol 213, Issue 3, Supplement, September 2011, Page S138.
  46. Clifton GT, Sears AK, Patil R, Shumway NM, Carmichael MG, Van Echo DG, Holmes JP, McCall S, Merrill GA, Ponniah S, Peoples GE, Mittendorf EA. Monitoring of circulating tumor cell trends in a prospective, randomized, placebo-controlled HER-2/neu peptide vaccine trial. Journal of Clinical Oncology, 2011 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 29, No 15_suppl (May 20 Supplement), 2011:e11126.
  47. Sears AK, Clifton GT, Patil R, Shumway NM, Carmichael MG, Van Echo DG, Holmes JP, Ponniah S, Mittendorf EA, Peoples GE. Sequential administration of trastuzumab and a CD8 T cell-eliciting HER-2/neu peptide vaccine in breast cancer patients compared to trastuzumab alone. Sequential administration of trastuzumab and a CD8 T-cell-eliciting HER2/neu peptide vaccine in patients with breast cancer compared to trastuzumab alone.  Journal of Clinical Oncology, 2011 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 29, No 15_suppl (May 20 Supplement), 2011:564.Journal of Clinical Oncology, 2011 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 29, No 15_suppl (May 20 Supplement), 2011:564.
  48. Sears AK, Clifton GT, Van Echo DC, Holmes JP, Zacharia A, Jama Y, Mursal M, Chiplis A, Mittendorf EA, Peoples GE, Ponniah S. Circulating regulatory T cells (CD4+CD25highCD127low) decrease in breast cancer patients after vaccination with a modified HER-2/neu HLA class II peptide (AE37) vaccine. Proc Am Assoc Cancer Res 2011;LB-413/11.
  49. Sears AK, Clifton GT, Carmichael MG, Van Echo DC, Holmes JP, Zacharia A, Jama Y, Mursal M, Chiplis A, Mittendorf EA, Peoples GE, Ponniah S. Comparison of in vitro and in vivo immunologic responses in a prospective, randomized, single-blinded phase II trial evaluating the HER-2/neu peptide vaccines GP2 and AE37 in breast cancer patients. Proc Am Assoc Cancer Res 2011;LB-414/12.
  50. Clifton GT, Sears AK, Perez SA, Clive KS, Holmes JP, Georgakopoulou K, Papamichail M, Ponniah S, Peoples GE, Mittendorf EA. Vaccine-specific immunologic responses to the HER-2/neu peptide (GP2) vaccine in a prospective, randomized phase II clinical trial. Ann Surg Oncol 2011;18 (Suppl 1):P59.
  51. Sears AK, Clifton GT, Perez SA, Clive K, Holmes JP, Georgakopoulou K, Papamichail M, Ponniah S, Peoples GE, Mittendorf EA. Vaccine-specific immunologic responses to the novel Ii-Key hybrid HER-2/neu peptide (AE37) vaccine in a phase II clinical trial. Ann Surg Oncol 2011;18 (Suppl 1): P60.
  52. Mittendorf EA, Perez S, Tzonis P, Clifton GT, Ardavanis A, Holmes JP, Lekka E, Baxevanis C, Ponniah S, Peoples GE, Papamichail M. Combination immunotherapy for breast cancer patients: safety and immunologic data from a phase II trials administering a HER2/neu-derived peptide vaccine (AE37+GM-CSF) sequentially or concurrently with trastuzumab in the adjuvant setting. Br Cancer Res Treat 2010 #P2-20-03.
  53. Olson MD, Clifton GT, Mittendorf EA, Peoples GE, Ponniah S, Holmes JP. Increased prevalence of HLA-DR3 among breast cancer patients: implications for Her2/neu peptide vaccine trials. Br Cancer Res Treat 2010 #P2-20-02.
  54. Vreeland TJ, Clifton GT, Patil R, Clive KS, Sears AK, Holmes JP, Mittendorf EA, Ponniah S, Peoples GE. Safety and clinical efficacy of multiple booster inoculations with the E75 adjuvant breast cancer vaccine. Br Cancer Res Treat 2010 #P2-20-01.
  55. Clifton GT, Clive K, Holmes J, Patil R, Benavides L, Gates J, Mittendorf EA, Stojadinovic A, Ponniah S, Peoples GE. Cumulative findings from the E75 peptide vaccine adjuvant trials in breast cancer. J Clin Oncol 2010 (In Press).
  56. Clive KS, Summers T, Clifton GT, Patil R, Tyler J, Holmes JP, Mittendorf EA, Stojadinovic A, Ponniah S, Peoples GE. Assessment of circulating tumor cell (CTC) patterns among disease-free breast cancer patients vaccinated with adjuvant HER2/neu-based peptide vaccines. J Clin Oncol 2010;28:#2542.
  57. Clifton GT, Clive K, Patil R, Holmes J, Benavides LC, Gates JD, Tyler J, Mittendorf EA, Ponniah S, Peoples GE. Effect of a novel II-key hybrid HER2/neu peptide (AE37) vaccine with GM-CSF as compared to GM-CSF alone on levels of regulatory T-cell (Treg) populations. J Clin Oncol 2010;28:#2565.
  58. Clifton GT, Patil R, Clive K, Tyler J, Zacharia A, Jama Y, Mursal M, Ciano K, Holmes JP, Mittendorf EA, Peoples GE, Ponniah S. Defining Regulatory T-cells as CD4+CD25hiCD127- or as CD4+CD25hiFoxP3+ in immune monitoring of cancer vaccine clinical trials. Proc Am Assoc Cancer Res 2010;#LB-329.
  59. Patil R, Clifton GT, Clive K, Tyler J, Zacharia A, Jama Y, Mursal M, Ciano K, Holmes JP, Mittendorf EA, Peoples GE, Ponniah S. A modified HER2/neu peptide vaccine (2L9V-GP2) demonstrates enhanced CD8+ T cell recognition and stimulation in breast cancer patients at high risk for recurrence. Proc Am Assoc Cancer Res 2010;#LB-322.