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

PARAMUS, N.J., April 23, 2012 /PRNewswire/ -- 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 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 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."

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.   

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).


'/>"/>
SOURCE Asubio
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
2. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
3. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
5. MedImmune Initiates Phase 2a Multi-Dose Study in Patients with Asthma
6. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
7. Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
8. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
9. Prolexys Pharmaceuticals Initiates Phase 1 Study
10. Isis Initiates Phase 1 Study of ISIS 325568 Targeting Glucagon Receptor to Treat Type 2 Diabetes
11. Lpath Demonstrates Preclinical Efficacy of Lpathomab(TM) and Initiates Humanization Process
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... On Thursday, Feb. 11, 2016, surgeons at ... North Austin Medical Center successfully completed the first robotic ... Surgical System with Trumpf Medical,s advanced operating table, ... , M.D., colorectal surgeon at the Texas Institute for ... Motion technology, which seamlessly combines the da Vinci Xi ...
(Date:2/12/2016)... 12, 2016  Eli Lilly and Company (NYSE: LLY ... Alimta® (pemetrexed disodium) vitamin regimen patent would not presently be ... France , Italy and ... product only with dextrose solution.  --> ... Court of Appeal held that Lilly,s patent would be indirectly ...
(Date:2/12/2016)... Ga. , Feb. 12 2016  OMS Supply, ... dental and medical practitioners, announced today the recent launching ... offers visitors a variety of features that enhance the ... oral surgery supplies. --> ... is a fairly new company that started in early ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, ... Parishes. The purpose of these scholarships is to encourage applicants to pursue a ... seek employment within these two parishes. , “We have available jobs in St. ...
(Date:2/12/2016)... ... 2016 , ... CDRH Enforcement Trends: , Back to the Future , Feb. 25, 2016 — ... Churchill said, “Those who don’t learn from history are doomed to repeat it.” , An ... knocking this year. But that takes time. , Take a close look at the ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... As a ... hectic schedule, a demanding job, and no time to decompress, Rabinowitz found herself drawn ... herself to meditation for its impact on her life, implementing a 20-minute-per-day meditation practice ...
(Date:2/12/2016)... ... February 12, 2016 , ... The ... Zuckerberg San Francisco General Hospital on April 5-7. The series is a multi-day, ... new habits. The workshops cover a broad range of topics, including coaching skills, ...
(Date:2/12/2016)... , ... February 12, 2016 , ... Fisher House Foundation ... Mayor John J. Lee, Nevada Military Support Alliance president Scott Bensing, and Peggy Kearns ... the VA Southern Nevada Healthcare System. This will be the first Fisher House ...
Breaking Medicine News(10 mins):