Multiple lines of evidence have validated the Rho pathway as important in controlling the neuronal response to growth inhibitory proteins after central nervous system (CNS) injury. A drug called @entity70088 (trademarked as @entity70088 (  )) blocks activation of Rho and has shown promise in pre-clinical animal studies in being used to treat @entity1566 ( @entity1566 ). This is a report of a Phase I/IIa clinical study designed to test the safety and tolerability of the drug, and the neurological status of @entity1 following the administration of a single dose of @entity70088 applied during surgery following acute @entity1566 . @entity1 with @entity1514 (T2-T12) or cervical (C4-T1) @entity1566 were sequentially recruited for this dose-ranging (0.3   mg to 9   mg @entity70088 ), multi-center study of 48 @entity1 with complete American @entity3510 Association assessment (ASIA) A. Vital signs; clinical laboratory tests; computed tomography (CT) scans of the spine, head, and abdomen; magnetic resonance imaging (MRI) of the spine, and ASIA assessment were performed in the pre-study period and in follow-up periods out to 1 year after treatment. The treatment-emergent adverse events that were reported were typical for a population of acute @entity1566 @entity1 , and no serious adverse events were attributed to the drug. The pharmacokinetic analysis showed low levels of systemic exposure to the drug, and there was high inter- @entity1 variability. Changes in ASIA motor scores from baseline were low across all dose groups in @entity1514 @entity1 (1.8  5.1) and larger in cervical @entity1 (18.6  19.3). The largest change in motor score was observed in the cervical @entity1 treated with 3   mg of @entity70088 in whom a 27.3  13.3 point improvement in ASIA motor score at 12 months was observed. Approximately 6% of @entity1514 @entity1 converted from ASIA A to ASIA C or D compared to 31% of cervical @entity1 and 66% for the 3-mg cervical cohort. Although the @entity1 numbers are small, the observed motor recovery in this open-label trial suggests that @entity70088 may increase neurological recovery after complete @entity1566 . Further clinical trials with @entity70088 in @entity1566 @entity1 are planned, to establish evidence of efficacy.

A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity3510 :: ('MESH:D013124', 'Disease') :: ['Spinal Injury'] @entity1514 :: ('MESH:D013896', 'Disease') :: ['thoracic'] @entity1566 :: ('MESH:D013119', 'Disease') :: ['spinal cord injury', 'SCI'] @entity70088 :: ('MESH:C063007', 'Chemical') :: ['BA-210', 'Cethrin']
@entity1566 :: (MESH:D013119,Disease) :: ['spinal cord injury']
