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Landmark Clinical Study in Spinal Cord Injury - Asubio


  • Published: 2012-04-23 (Revised/Updated 2012-09-19) : Author: Asubio
  • Synopsis: Phase 2 clinical trial of SUN13837 an investigational medication developed to improve neurological function in patients with newly diagnosed acute spinal cord injury.

Long-term commitment to evaluating the impact of SUN13837 on neurological function discussed at American Spinal Injury Association symposium.

Spinal Cord Injury - Spinal cord trauma is damage to the spinal cord. It may result from direct injury to the cord itself or indirectly from damage to surrounding bones, tissues, or blood vessels. When spinal cord injuries occur in the neck area, symptoms can affect the arms, legs, and middle of the body. The symptoms may occur on one or both sides of the body.

Today, Asubio announced the initiation of a landmark Phase 2 clinical trial of SUN13837, an investigational medication being developed to improve neurological function in patients with newly diagnosed acute spinal cord injury.

In accordance with its internal focus on scientific rigor, Asubio recently discussed its endpoint development activities at a peer-attended symposium at the American Spinal Injury Association (ASIA) annual meeting. The company also reinforced its long-term strategic and financial commitment to completing the clinical trial.

Asubio is working with 60 acute trauma centers throughout the United States and Canada to enroll 164 patients in the clinical trial.

Trauma centers must first sign on to participate in the study, and then attending trauma physicians and nurses will identify eligible patients when they arrive at a facility with a spinal cord injury. Physicians or trauma center representatives can write Ben Levinson at blevinson@asubio.com for more information about participation, or visit ClinicalTrials.gov (NCT01502631).

"Valid clinical trial programs, such as the acute spinal cord injury study being supported by Asubio provide an objective path to understanding and improving life after spinal cord injury," said John Steeves, PhD, Peter Wall Distinguished Scholar in Residence, Professor and Founding Director of ICORD (International Collaboration On Repair Discoveries). "I encourage all Level One Trauma Centers to consider informing and enrolling appropriate participants."

This randomized, placebo-controlled study will determine whether subjects receiving SUN13837 are more likely to improve by two or more motor levels from baseline on either their right or left side as determined using the International Standards for Neurological Classification of Spinal Cord Injury Scale. Patients will be selected 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 neuro-protection 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) neuro-protection by limiting the degree of primary mechanical damage at the injury site, 2) augmentation of axonal outgrowth in the otherwise unfavorable post-injury micro-environment, 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 publication by Kramer et al.[1.] The potential outcome of this trial may support greater independence for patients with spinal cord injury, and help reduce demands on healthcare resources," added Dr. Levinson. "Of course, cautious optimism is needed until this and other studies have been conducted. Nonetheless, we are hopeful that SUN13837 will offer a significant advance in the treatment of this devastating, life-altering type of trauma."

Asubio, a group company of Daiichi Sankyo, is committed to building a brighter, healthier tomorrow by developing ethical pharmaceuticals that improve the health and wellbeing of people with unmet medical needs around the world. Asubio Pharmaceuticals, located in Paramus, New Jersey, is the U.S. subsidiary of Asubio Pharma Company, Limited, which is based in Kobe, Japan. Asubio Pharmaceuticals, Inc. is a research-based pharmaceutical company involved in the development of drug compounds from Phase 1 clinical trials through Phase 2 proof of concept. In early 2012 Asubio initiated a new Phase 2 clinical study in patients with newly diagnosed acute spinal cord injury, to determine whether the investigative new drug SUN13837 improves neurological function in this catastrophic injury.

Reference:

[1.] Kramer, JLK, Lammertse, DP, Schubert, M, Curt, A, Steeves, JD. Relationship between motor recovery and independence after sensorimotor complete cervical spinal cord injury.Neurorehabilitation and Neural Repair (in press).

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