Drug Development

Hematotoxicity Testing by Cell Clonogenic Assay in Drug Development and Preclinical Trials. A Pessina, I Malerba, L Gribaldo. Institute of Microbiology, Milan, Italy. Current Pharmaceutical Design, March; 11(8): 1055-65, 2005.

A predictive model of human myelotoxicity using five camptothecin derivatives and the in vitro colony-forming unit granulocyte/macrophage assay. N. Masubuchi, RD May, R Atsumi. Drug Metabolism and Physicochemical Property Research Laboratory, Daiichi Pharmaceutical Co., Tokyo, Japan.Clin Cancer Res, Oct 1; 10(19): 6722-31, 2004.

Application of the CFU-GM Assay to Predict Acute Drug-Induced Neutropenia: An International Blind Trial to Validate a Prediction Model for the Maximum Tolerated Dose (MTD) of Myelosuppressive Xenobiotics. A Pessina*,1, B Albella, M Bayo*, J Bueren, P Brantom, S Casati, C Croera*, G Gagliardi*, P Foti*, R. Parchment¶, D Parent-Massin|, G Schoeters||, Y Sibiril|, R Van Den Heuvel||, L Gribaldo. *Institute of Microbiology, Milan, Italy; CIEMAT, Madrid, Spain; BIBRA International, Carshalton, United Kingdom; ECVAM, Institute for Health and Consumer Protection, Joint Research Centre, European Commission, Ispra, Italy; ¶Wayne State University, Detroit, Michigan 48202; |ESMISAB, Plouzanè, France; and ||VITO, Mol, Belgium. Toxicology In Vitro June; 17(3): 271-7, 2003.

Use of CFU-GM Assay for Prediction of Human Maximum Tolerated Dose of a New Antitumoral Drug: Yondelis (ET-743). Gomez SG, Bueren JA, Faircloth G, Albella B. PharmaMar, S.A. Poligono Industrial La Mina, Avda de los Reyes, 1.28770 Colmenar Viejo, Madrid, Spain. Toxicology In Vitro Oct-Dec; 17(5-6): 671-4, 2003.

Lisofylline Inhibits Transforming Growth Factor Beta Release and Enhances Trilineage Hematopoietic Recovery after 5-fluorouracil Treatment in Mice. E Clarke, GC Rice, RS Weeks, N Jenkins, R Nelson, JA Bianco, JW Singer. Cell Therapeutics, Inc., Seattle, Washington, USA. Cancer Res Jan 1; 56(1): 105-12, 1996.

Hematologic toxicity of high-dose iodine-131-metaiodobenzylguanidine therapy for advanced neuroblastoma. DuBois SG, Messina J, Maris JM, Huberty J, Glidden DV, Veatch J, Charron M, Hawkins R, Matthay KK. Department of Pediatrics, University of California, San Francisco, CA 94143, USA. J Clin Oncol Jun 15; 22(12): 2452-60, 2004.

Myeloid Clonogenic Assays for Comparison of the In Vitro Toxicity of Alkylating Agents. DA Volpea, MK Warrenb,1. aCenter for Drug Evaluation and Research, Food and Drug Administration, Rockville, 5600 Fishers Lane, Rockville, MD 20857, USA; bPoietic Technologies, Inc., Gaithersburg, MD, USA. Toxicology in Vitro Feb; 17(1): 69-75, 2003.

Inhibition of CFU-E/BFU-E and CFU-GM Colony Growth by Cyclophosphamide, 5-Fluorouracil and Taxol: Development of a High-Throughput In Vitro Method. Malerba I, Casati S, Diodovich C, Parent-Massin D, Gribaldo L. Laboratory of Hematotoxicology, ECVAM, Institute for Health and Consumer Protection, J.R.C., Ispra, Italy. Toxicol In Vitro Jun; 18(3): 293-300, 2004.

In Vitro Toxicity of ET-743 and Aplidine, Two Marine-Derived Antineoplastics, on Human Bone Marrow Haematopoietic Progenitors: Comparison with the Clinical Results. B Albellaa,*, G Fairclothb, L López-Lázaroc, C Guzmánc, J Jimenoc, JA Buerena. aDepartment of Molecular and Cellular Biology, CIEMAT Madrid Spain, bPharmaMar, Inc., Cambridge MA USA, cPharmaMar, Clinical R&D, Tres Cantos, Madrid Spain. European Journal of Cancer 38: 1395-1404, 2002.

Refinement of the Colony-Forming Unit-Megakaryocyte (CFU–MK) Assay for its Application to Pharmaco-Toxicological Testing. S Casati a, A Collottab, R Clothierc, L Gribaldoa. aECVAM, European Centre for the Validation of Alternative Methods, Institute for Health and Consumer Protection, Joint Research Centre, Ispra, Italy; b IES, Institute for Environmental Sustainability, Joint Research Centre, Ispra, Italy; c FRAME Alternatives Laboratory, School of Biomedical Sciences, Medical School, Queen's Medical Centre, Nottingham NG7 2UH, UK. Toxicology in Vitro June; 16(3): 281-8, 2002.

Synergistic Bone Marrow Toxicity of Pyrimethamine and Zidovudine in Murine In Vivo and In Vitro models: Mechanism of Toxicity. YR Freund, J Dabbs, MR Creek, SJ Phillips, CA Tyson, JT MacGregor. SRI International, Menlo Park, California 94025-3493, USA. Toxicology and Applied Pharmacology May 15; 181(1): 16-26, 2002.

Rat Granulocyte Colony-Forming Unit (CFU-G) Assay for the Assessment of Drug-Induced Hematotoxicity. K Matsumura-Takedaa, K Kotosaia, A Ozakia, H Harab, S Yamashitaa. a Tokushima Research Institute, Otsuka Pharmaceutical Co. Ltd, Tokushima, Japan; b Department of Blood Transfusion, Hyogo College of Medicine, Nishinomiya, Japan. Toxicology in Vitro Aug-Oct; 15(4-5): 347-50, 2001.

Cytochrome P4502E1 is Present and Active in Human Hematopoietic Stem Cells. P Anzenbacher1, E Anzenbacherova2, L Kousalova1, J Vondrakova3, I Skoumalova3. 1Institute of Pharmacology and 2Institute of Medical Chemistry and Biochemistry, Faculty of Medicine, Palacky University, CZ-775 15 Olomouc, and 3Department of Hematology, University Hospital, CZ-775 20 Olomouc, Czech Republic. 10th International Congress of Toxicology, July 11-15, 2004, Tampere Finland.

Idarubicinol Myelotoxicity: A Comparison of In Vitro Data with Clinical Outcome in Patients Treated with High-Dose Idarubicin. C Corsini, M Ghielmini, P Mancuso, F Tealdo, M Paolucci, M Zucchetti, PF Ferrucci, E Cocorocchio, M Mezzetti, A Mori, M Riggi, M D'Incalci, G Martinelli. Hematology/Oncology Department, European Institute of Oncology, Milan, Italy. British J Cancer Feb; 82(3): 524-8, 2000.

Predicting Hematological Toxicity (Myelosuppression) of Cytotoxic Drug Therapy from In Vitro Tests. RE Parchment, M Gordon, CK Grieshaber, C Sessa, D Volpe, M Ghielmini. Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA. Ann Oncol Apr; 9(4): 357-64, 1998.

In Vivo and In Vitro Comparison of the Short-Term Hematopoietic Toxicity Between Hydroxyurea and Trimidox or Didox, Novel Ribonucleotide Reductase Inhibitors with Potential anti-HIV-1 Activity. CN Mayhew, JD Phillips, RN Greenberg, NJ Birch, HL Elford, VS Gallicchio. School of Health Sciences, University of Wolverhampton, United Kingdom. Stem Cells 17(6): 345-56, 1999.

Role of SR-4987 Stromal Cells in the Modulation of Doxorubicin Toxicity to In Vitro Granulocyte-Macrophage Progenitors (GM-CFU). A Pessina, M Piccirillo, E Mineo, P Catalani, L Gribaldo, E Marafante, MG Neri, A Raimondi. Cell Culture Laboratory, Institute of Medical Microbiology, University of Milan, Italy. Life Sci 65: 513-23, 1999.