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An escalating dose of Cethrin(R) (0.3, 1.0, 3.0, or 6 mg.) was administered to the injured spinal cord during surgical decompression/reconstruction. This occurred within five days of the SCI incident, with the average time being 53 hours. All adverse events were recorded and neurological outcomes were assessed using ASIA standards at 0, 1.5, 3, 6 and 12 months. The following outcomes were noted:
-- There were no serious adverse effects related to Cethrin(R).
-- The complete 6-month patient data showed, 28 percent of patients (10 of
36) improved by one or more ASIA grades as compared to reported
literature results of 6.7% (Burns, J.Neurotrauma, 2003).
-- Five patients improved to ASIA C and two patients improved to ASIA D.
One patient with a thoracic SCI died from acute respiratory distress
syndrome (ARDS).
About Cethrin
Cethrin is a recombinant protein drug intended to facilitate the re-growth of axons during the critical period immediately after a major injury to the spinal cord. Following an SCI, about two-thirds of patients undergo decompression/stabilization surgery. In this surgery, Cethrin is delivered in a single dose directly onto the injured region of the spinal cord without the need for further invasive procedures. Cethrin has been designated an Orphan Drug.
About Boston Life Sciences
Boston Life Sciences, Inc. (BLSI) is engaged in the research and
clinical development of diagnostic and therapeutic products for
central nervous system (CNS) disorders. Cethrin(R), a
recombinant-protein-based drug designed to promote n
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