Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)
Announcement
Collapse
No announcement yet.
Dr. Wise what is SUN13837 Injection
Collapse
X
-
http://www.news-medical.net/news/201...rd-injury.aspx
Asubio commences SUN13837 Phase 2 clinical trial for acute spinal cord injury
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."
Continued on Next page >>
-
I am so happy that this is relevant to us chronics, there is much reason for us to be intrigued"That's not smog! It's SMUG!! " - randy marsh, southpark
"what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "
2010 SCINet Clinical Trial Support Squad Member
Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature
Comment
-
Originally posted by c473s View PostRecruiting opens this coming Tuesday at Emory/Grady in Atlanta
Here's the link at clinical trial .gov http://clinicaltrials.gov/ct2/show/NCT01502631
Comment
-
Originally posted by GRAMMY View PostThanks for letting us know about this acute injury trial c473s! Good news it is.
Here's the link at clinical trial .gov http://clinicaltrials.gov/ct2/show/NCT01502631
Comment
-
Originally posted by lunasicc42 View PostI am so happy that this is relevant to us chronics, there is much reason for us to be intrigued
well, good news for people that dont know it yet atleast. I would be happy to know that if my loved ones suffered a spinal cord injury that they will not have to go through what I am.
Comment
-
Originally posted by c473s View PostRumors are carrying more heat that Neural Stim is readying for chronic trials. Have to wait until the fire actually lights though.
Comment
-
Originally posted by Jawaid View PostWhat is Neural stim? Any one can tell?
http://www.neuralstem.com/cell-therapy-for-csci
Comment
-
Originally posted by GRAMMY View PostThanks for letting us know about this acute injury trial c473s! Good news it is.
Here's the link at clinical trial .gov http://clinicaltrials.gov/ct2/show/NCT01502631
Comment
-
Let us wait for some news for lumbosacral injuries from W2W otherwise there is nothing being done for lumbosacral injuries. Sorry to say. Wise is doing animal research but still away from human trials. Ch'ase will also take 2 to 3 years it looks so no real hope still in near future.
Comment
Comment