Darryl C Baptiste1, Allyson Tighe, Michael G Fehlings. 1. University Health Network, Toronto Western Hospital, Toronto Western Research Institute, Krembil Neuroscience Centre, Toronto, Ontario, Canada. Darryl.Baptiste@uhnresearch.ca
Abstract
BACKGROUND: This review discusses the urgent need for improved therapeutic approaches aimed at restoring function following traumatic spinal cord injury (SCI). The focus of this paper is neuroregenerative approaches for SCI, with a highlighted comparison of recent advances in the field and comparisons to that made by Cethrin (Alseres Pharmaceuticals, Inc.), the leading nerve repair product. OBJECTIVE: This review first provides the reader with an understanding of SCI. The market for promising therapeutics that can either intervene in secondary etiological mechanisms or ameliorate symptoms associated with SCI are then discussed. The reader will also learn about Cethrin and its current status in clinical evaluation. METHODS: Review of the preclinical literature and clinical SCI trials relevant to the discovery and current development of Cethrin. RESULTS/ CONCLUSION: In a recently concluded Phase I/IIa clinical trial involving 37 patients with either cervical or thoracic SCIs, the evidence for Cethrin indicates that topical administration of either 0.3, 1, 3 or 6 mg of the recombinant rho inhibitor following surgical decompression is safe. Alseres has announced that planning is underway for a Phase IIB trial of Cethrin to include a placebo arm to assess better the drugs' clinical efficacy.
BACKGROUND: This review discusses the urgent need for improved therapeutic approaches aimed at restoring function following traumatic spinal cord injury (SCI). The focus of this paper is neuroregenerative approaches for SCI, with a highlighted comparison of recent advances in the field and comparisons to that made by Cethrin (Alseres Pharmaceuticals, Inc.), the leading nerve repair product. OBJECTIVE: This review first provides the reader with an understanding of SCI. The market for promising therapeutics that can either intervene in secondary etiological mechanisms or ameliorate symptoms associated with SCI are then discussed. The reader will also learn about Cethrin and its current status in clinical evaluation. METHODS: Review of the preclinical literature and clinical SCI trials relevant to the discovery and current development of Cethrin. RESULTS/ CONCLUSION: In a recently concluded Phase I/IIa clinical trial involving 37 patients with either cervical or thoracic SCIs, the evidence for Cethrin indicates that topical administration of either 0.3, 1, 3 or 6 mg of the recombinant rho inhibitor following surgical decompression is safe. Alseres has announced that planning is underway for a Phase IIB trial of Cethrin to include a placebo arm to assess better the drugs' clinical efficacy.
Authors: Sujata Saraswat Ohri; Melissa A Maddie; Yiping Zhang; Christopher B Shields; Michal Hetman; Scott R Whittemore Journal: J Neurotrauma Date: 2011-11-21 Impact factor: 5.269