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news.Alseres Pharmaceuticals has reported that an independent data safety monitoring board has unanimously authorized expanding its Phase I/IIa clinical trial in acute spinal cord injury to allow subjects with cervical SCI to be treated with a 9mg dose of Cethrin.
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This recommendation is based on the safety analyses of data from thoracic subjects who have been treated at the 9mg dosage level and overall evaluation of safety of the drug in this clinical trial to date.
Each dose level was first given to thoracic acute spinal cord injury (SCI) subjects and then, following review by the data safety monitoring board (DSMB), the dose level was extended to cervical subjects. Authorization to administer a 9mg dose was given by the FDA in June 2007 and earlier by Health Canada.
Dr Mark Hurtt, Alseres’ CMO, said: “The DSMB’s recommendation is an important step in the Cethrin clinical plan. The inclusion of 9mg cervical subjects will increase our understanding of the encouraging efficacy data for Cethrin at lower doses, and provide additional safety data to support the Phase IIb/III clinical study, expected to begin patient enrollment in early 2008.”