PUBLICATIONS
Alfano, R.W., Leppla, S.H., Liu, S., Bugge, T., Meininger, C.J., Lairmore, T.C., Mulne, A.F., Davis, S.H., Duesbery, N.S., Frankel, A.E., Matrix metalloproteinase-activated anthrax lethal toxin inhibits endothelial invasion and neovasculature formation during in vitro morphogenesis. In review.
Liu, S., Wang, H., Currie, B.M., Molinolo, A., Leung, H.J., Moayeri, M., Basile, J.R., Alfano, R.W., Gutkind, J.S., Frankel, A.E., Bugge, T.H., Leppla, S.H.. Matrix metalloproteinase-activated anthrax lethal toxin demonstrates high potency in targeting tumor vasculature. J Biol Chem 2008; 283(1):529-40.
Alfano, R.W., Leppla, S.H., Liu, S., Bugge, T.H., Duesbery, N.S., Frankel, A.E., Potent inhibition of tumor angiogenesis by the matrix metalloproteinase-activated anthrax lethal toxin: implications for broad anti-tumor efficacy. Cell Cycle 2008; 7(6):745-9.
Alfano, R.W., Leppla, S.H., Liu, S., Bugge, T.H., Herlyn, M., Smalley, K.S., Bromberg-White, J.L., Duesbery, N.S., Frankel, A.E., Cytotoxicity of the matrix metalloproteinase-activated anthrax lethal toxin is dependent on gelatinase expression and B-RAF status in human melanoma cells. Mol Cancer Ther 2008; 7(5):1218-26.
Woo, J.H., Liu, J., Kang, S.H., Singh, R., Park, S.K., Su, Y., Ortiz, J., Neville Jr., D.M., Willingham, M.C. and Frankel, A. E., 2008. GMP production and characterization of the bivalent anti-human T cell immunotoxin, AdmDT390-bisFv(UCHT1) for phase I/II clinical trials. Protein Expr. Purif. 58(1):1-11.
Woo, J. H., Bour, S., Dang, T., Lee, Y., Park, S.K., Andreas, E., Kang, S. H., Liu, J., Neville Jr., D.M. and Frankel, A.E., 2008. Preclinical studies in rats and squirrel monkeys for safety evaluation of the bivalent anti-human T cell immunotoxin, A-dmDT390- bisFv(UCHT1). Cancer Immunol. Immunother. 57(8):1225-1239.
Awasthi, S., Singhal, S.S., Awasthi, Y.C., Martin, B., Awasthi, S., Woo, J.H., Cunningham, C.C. and Frankel, A.E., 2008. RLIP76 and cancer. Clin. Cancer Res. 14(14):4372-4377.
Kuo, S.R., Bour, S.H., Andreas, E.A., Park, S.K., Jackson, C., Duesbery, N., Leppla, S.H., Tang, W.J., Frankel, A.E., Anthrax toxin-induced shock in rats is associated with pulmonary edema and hemorrhage. Microbial Pathog 44: 467-472, 2008.
Frankel, A.E., Liu, J.S., Rizzieri, D.A. and Hogge, D.E. (2008) Phase I clinical study of diphtheria toxin-interleukin 3 fusion protein in patients with acute myeloid leukemia and myelodysplasia. Leukemia & Lymphoma 49:543-553
Liu Y, Dolence J, Ren J, Rao M. N.A, Sreejayan N (2008) Inhibitory effect of dehydrozingerone on vascular smooth muscle cell function. Journal of Cardiovascular Pharmacology. 52:422-9.
Wang, Z., Kim, G.B., Woo, J.H., Liu, Y.Y., Mathias, A., Stavrou, S. and Neville, Jr., D. M., 2007. Improvement of a recombinant anti-monkey anti-CD3 diphtheria toxin based immunotoxin by yeast display affinity maturation of the scFv. Bioconjugate Chemistry 18(3):947-955.
Woo, J.H., Liu, J. S., Kang, S.H., Singh, R., Park, S.K., Su, Y., Ortiz, J., Neville, D.M., Willingham, M.C., Frankel, A.E., GMP production and characterization of the bivalent antihuman T cell immunotoxin, AdmDT390- bisFv(UCHT1) for phase I/II clinical trials. Protein Expr Purif 2007; Nov 22, Epub.
Su,Y., Vanderlaag, K., Ireland, C., Ortiz, J., Grage, H., Safe, S. and Frankel, A.E., 2006. 1, 1-bis(3’- indolyl)-1-(p-biphenyl)methane inhibits basal-like breast cancer growth in athymic nude mice. Breast Cancer Res. 2007 Aug 31;9(4):R56 Epub.
Vanderlaag, K., Su,Y., Frankel, A.E., Grage, H., Smith R. 3rd, Khan, S., Safe, S. 1,1-Bis(3’-indolyl)-1 (psubstituted phenyl) methanes inhibit proliferation of estrogen receptornegative breast cancer cells by activation of multiple pathways. Breast Cancer Research and Treatment. 2007 Jul 12, Epub.
Su Y, Ortiz, J., Singh, R., Liu, S., Bugge, T.H., Leppla, S.H. and Frankel, A.E., 2006. Systematic urokinase-activated anthrax toxin therapy produces regressions of subcutaneous human non-small cell lung tumor in athymic nude mice. Cancer Research. 2007 April 67, 3329-3336.
Combs DJ, Nagel RJ, Ares M Jr, and Stevens SW. (2006) Prp43p Is a DEAH-Box Spliceosome Disassembly Factor Essential for Ribosome Biogenesis Mol Cell Biol. 26(2):523-34.
Li S-Y, Yang X, Ceylan-Isik AF, Du M, Ren BH, Sreejayan N, Ren J. 2006. Cardiace contracticle dysfunction in ob/ob obesity is accompanied with oxidative modification of sarco(endo)plasmic reticulum Ca2_-ATPase and myosin heavy chain isozyme switch. Diabetologia. 49:1434-46.
Yang, X, Li S-Y, Dong F, Ren J, Sreejayan N. 2006. Insulin-sensitizing and cholesterol-lowering effects of chromium (d-Pheylalanine)(3). J Inorg Biochem. 100:1187-93.
Li S-Y, Li Q, Shen JJ, Dong F, Sigmon VK, Liu Y, Ren J. 2006. Attenuation of acetaldehyde-induced cell injury by overexpression of aldehyde dehydrogenase-2 (ALDH2) transgene in human cardiac myoctes: role of MAP kinase signaling. J. Mol. Cell Cardiol. 40:283-294.
Xu P. Li S-Y, Li Q, Ren J, Van Kirk EA, Murdoch WJ, Radosz M, Shen Y. 2006. Biodegradable cationic polyester as an efficient carrier for gene delivery to neonatal cardiomyocytes. Biotecnology and Bioengineering 95:893-903.
Li SY, Li Q, Shen JJ, Dong F, Sigmon VK, Liu Y, Ren J. (2006) Attenuation of acetaldehyde-induced cell injury by overexpression of aldehyde dehydrogenase-2 (ALDH2) transgene in human cardiac myocytes: role of MAP kinase signaling. J Mol Cell Cardiol. 40:283-94.
Li SY, Liu Y, Sigmon VK, McCort A, Ren J. (2005) High-fat diet enhances visceral advanced glycation end products, nuclear O-Glc-Nac modification, p38 mitogen-activated protein kinase activation and apoptosis. Diabetes Obes Metab. 7:448-54.
RELEVANT FDA REGULATIONS
Also available at www.fda.gov
21 CFR Part 11 Electronic Records; Electronic Signatures
21 CFR Part 50 Protection of Human Subjects
21 CFR Part 54 Financial Disclosure by Clinical Investigators
21 CFR Part 56 Institutional Review Boards
21 CFR Part 58 Good Laboratory Practice
21 CFR Part 210-211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 312 Investigational New Drug Application
21 CFR Part 600 Biological Products
21 CFR Part 610 General Biological Standards
Guidance for Industry- CGMP for Phase 1 Investigation Drugs
Guidance for Industry- Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
RELEVANT INDA SUBMISSIONS
INDA: 11314: Therapy Targeting the Interleukin-3 Receptor (IL3R) for Patients with Relapsed or Refractory and Elderly or Poor-Risk Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome with DT388IL3 (IND# 11314): a Phase I/II Clinical Trial
INDA: 100712: A Phase I/II Study of A-dmDT390-bisFv (UCHT1) Fusion Protein in Patients with surface CD3+ malignant T cell disease
INDA: 100780: A Phase I Study of DT2219ARL (IND# 100780), A Bispecific Single Chain Immunotoxin for the Treatment of CD19(+), CD22(+) B-Lineage Acute Lymphoblastic Leukemia
INDA: 12866 : A Phase 1 Trial of PSAActivated PSA-PAH1 Therapy for Locally Recurrent Prostate Cancer Without Metastases After Primary Radiation Therapy