Asubio Broadens Inclusion Criteria For Landmark Spinal Cord Injury Clinical Trial

Progress of ASCENT-ASCI Phase 2 Trial of SUN13837 Discussed at American Spinal Injury Association Symposium

PARAMUS, N.J. , July 8, 2013 /CNW/ - Asubio Pharmaceuticals, Inc. today announced the expansion of enrollment for its ASCENT-ASCI (Asubio Spinal Cord Early Neuro-recovery Treatment for Acute Spinal Cord Injury) trial to include AIS A, B and C injury to the cervical spine. ASCENT-ASCI is a Phase 2 clinical trial evaluating SUN13837, an investigational medication being developed to improve neurological function in patients with newly diagnosed acute spinal cord injury. Asubio recently discussed the expanded inclusion criteria and progress of the study at a peer-attended symposium at the American Spinal Injury Association ( ASIA ) 40th Anniversary annual meeting in Chicago , Illinois .

The company is currently working with 45 acute trauma centers throughout the United States and Canada and plans to increase that number to 55. Trauma centers must first sign up to participate in the clinical trial and then brief attending trauma physicians and nurses on how to rapidly identify eligible spinal cord injury patients when they first arrive at their facility. In addition to the 45 acute trauma centers, there are also 13 stand-alone rehabilitation centers participating in the study. Interested physicians or trauma/rehabilitation center representatives should contact Ben Levinson at blevinson@asubio.com for more information regarding ASCENT-ASCI trial participation, or visit ClinicalTrials.gov (NCT01502631).

"The recent adoption of a more inclusive Asubio trial protocol will meet the needs of a broader number of spinal cord injuries and enable a more sensitive and accurate determination of therapeutic benefit across a wider range of functional disability," said John Steeves , PhD, Peter Wall Distinguished Scholar in Residence, Professor and Founding Director of ICORD (International Collaboration On Repair Discoveries). "I encourage major trauma centers to consider participation and informing and enrolling appropriate patients."

"It takes a small community to pull off an acute spinal cord injury study, but with a bit of planning, it can be done," explained Laura Wollenweber , a clinical research coordinator at the Medical College of Wisconsin in Milwaukee , who spoke of her experience enrolling patients in the study. Dr. Levinson added: "Of course, cautious optimism is warranted, but we are hopeful that the broadened enrollment criteria will bring new hope for a wider range of patients suffering from this devastating, life-altering type of trauma."

About SUN13837

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.

"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."

About Asubio

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.

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Asubio Broadens Inclusion Criteria For Landmark Spinal Cord Injury Clinical Trial