- ASTIN: a Bayesian adaptive dose-response trial in acute stroke
Andrew P Grieve
Statistical Research and Consulting Centre, Pfizer Global Research and Development, Sandwich, Kent, UK
Clin Trials 2:340-51; discussion 352-8, 364-78. 2005
..The design was deployed in ASTIN, a phase II proof-of-concept trial of the neuroprotectant, neutrophil inhibitory factor (NIF), in acute stroke. We discuss the learning from this trial...
- Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN): an adaptive dose-response study of UK-279,276 in acute ischemic stroke
Pfizer Global Research and Development, Sandwich, UK
Stroke 34:2543-8. 2003
..The prime objective was to determine the dose that gave a clinically relevant effect in patients...
- Role of mechanistically-based pharmacokinetic/pharmacodynamic models in drug development : a case study of a therapeutic protein
Department of Clinical Pharmacology, Pfizer Global Research and Development, Sandwich, UK
Clin Pharmacokinet 45:177-97. 2006
..UK-279,276 binds to the CD11b/CD18 (MAC-1) on neutrophils and was under development for the treatment of ischaemic stroke...
- UK-279,276, a neutrophil inhibitory glycoprotein, in acute stroke: tolerability and pharmacokinetics
Kennedy R Lees
University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary, Glasgow, G11 6NT, UK
Stroke 34:1704-9. 2003
..The purposes of this study were to evaluate the safety and tolerability of UK-279,276 and to examine its pharmacokinetics and pharmacodynamics (binding to neutrophil CD11b) in patients with acute stroke...
- A longitudinal model for non-monotonic clinical assessment scale data
Department of Pharmaceutical Biosciences Division of Pharmacokinetics and Drug Therapy, Uppsala University, Sweden
J Pharmacokinet Pharmacodyn 32:795-815. 2005
..We conclude that this approach has considerable potential for more efficient use of information in longitudinal modeling of non-monotonic clinical assessment scale data...
- Bridging the pharmacokinetics and pharmacodynamics of UK-279,276 across healthy volunteers and stroke patients using a mechanistically based model for target-mediated disposition
E Niclas Jonsson
Division of Pharmacokinetics and Drug Therapy, Department of Pharmaceutical Biosciences, Uppsala University, Box 591, SE 751 24, Uppsala, Sweden
Pharm Res 22:1236-46. 2005
..The aim of this current analysis was to develop a mechanistically based model to bridge the differences between healthy volunteers and patients...
- Effects of a selective CD11b/CD18 antagonist and recombinant human tissue plasminogen activator treatment alone and in combination in a rat embolic model of stroke
Department of Neurology, Henry Ford Health Sciences Center, Detroit, MI 48202, USA
Stroke 34:1790-5. 2003
..We evaluated the neuroprotective effect of UK-279,276 (also referred to as recombinant neutrophil inhibitory factor), a selective CD11b/CD18 antagonist, in combination with thrombolytic therapy on focal cerebral ischemia...
- Assessing combination treatments in acute stroke: preclinical experiences
Department of Biostatistics and Research Epidemiology, Henry Ford Health Sciences Center, One Ford Place 3E, Detroit, MI 48202, USA
Behav Brain Res 162:165-72. 2005
..Treatment success may require combining different therapeutic approaches. An obvious treatment combination in acute ischemic stroke is a thrombolytic therapy, adjuvant with a neuroprotective agent to have better stroke recovery...
- The past is the future: innovative designs in acute stroke therapy trials
Pfizer Global Research and Development, Groton, Conn, USA
Stroke 36:1341-7. 2005
- Missing steps in the STAIR case: a Translational Medicine perspective on the development of NXY-059 for treatment of acute ischemic stroke
Giora Z Feuerstein
Wyeth Research, Collegeville, Pennsylvania 19426, USA
J Cereb Blood Flow Metab 28:217-9. 2008
..Finally, rational patient selection and new outcome scales tailored in an adaptive design model must be evaluated...