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Asubio Initiates Landmark Clinical Study in Spinal Cord Injury
Date:4/23/2012

d based on their baseline cervical motor level of sensori motor complete spinal cord injury (ASIA Impairment Scale A, with a C4 to C7 level of cord injury) and will be stratified according to the baseline cervical motor level.

"SUN13837 is expected to provide neuroprotection from glutamate excito-toxicity and promote axonal outgrowth, which is often inhibited after spinal cord injury," said Benjamin Levinson, M.D., Senior Director of Medical and Scientific Affairs at Asubio. "It is similar in mechanism to basic fibroblast growth factor (bFGF) but without the troublesome complication of stimulating cell proliferation. Like bFGF, SUN13837 is thought to bind with FGF receptors to induce the intracellular signaling events providing its positive properties.  Unlike bFGF (a large protein), SUN13837 is a highly lipid soluble small molecule that can be easily and reliably administered through peripheral intravenous injection."

SUN13837 has been without significant side effects in Phase 1 studies in healthy subjects. Experimental evidence has shown SUN13837 to have both neuroprotective and axonal outgrowth properties using both invitro studies and animal models of spinal cord injury.  In these models, SUN13837 administration improved corticospinal neuron survival and axonal regrowth, resulting in statistically significant functional recovery relative to placebo.  The preclinical evidence supports the concept that potential drug benefits will be due to 1) neuroprotection by limiting the degree of primary mechanical damage at the injury site, 2) augmentation of axonal outgrowth in the otherwise unfavorable post-injury microenvironment, and 3) facilitation of functional neural plasticity within surviving and newly formed neural circuits.

"A two motor-level improvement in a mid-cervical injury can have a significant impact for improving a patient's activities of daily living, including self-care and mobility according to a recent publ
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