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Preparing for First-in-Man studies is an exciting phase of a project. It is a huge value inflection point and bring the reality of the creation of a new medicine so much closer. CBV has experience in achieving this important project milestones & can provide the guidance you may need.
Clinical evaluation of BB-10010, an engineered chemokine
To transition into clinical evaluation with aggressive timelines & budget
Identify gobal opinion leaders, to meet and to select key clinical partners to lead centres through Phase I and Phase II international studies.
Marshall E., Lord BI., Howell AH., Powles R., Hunter MG., Edwards M, Wood LM., Czaplewski LG., Puttick R., Warington S., Boyce M., Testa N., Dexter TM., Lord BI., Millar A. Clinical effects of human MIP�1alpha (LD78) administration to humans: A phase I study in cancer patients and normal healthy volunteers with the genetically engineered variant BB-10010. European Journal of Cancer 34(7), 1023-1029, 1998.
Czaplewski LG., McCourt M., Hunter MG., Lord BI., Millar A., Wood LM. Engineering, biology and clinical development of hMIP-1 alpha in Chemokines in Human Disease (Hebert C., ed.) Humana Press Inc, Totowa NJ. 1998.
Clemons MJ., Marshall E., Durig J., Watanabe K., Howell A., Miles D., Earl H., Kiernan J., Griffiths A., Towlson K., DeTakats P., Testa NG., Dougal M., Hunter MG., Wood LM., Czaplewski LG., Millar A., Dexter TM., Lord BI. A randomised phase-II study of BB-10010 (Macrophage inflammatory protein-1 alpha with advanced breats cancer receiving 5-FU, adriamycin and cyclophosphamide (FAC) chemotherapy. Blood 92, 1532-1540, 1998.