MONTREAL, Nov. 27 /PRNewswire/ - BioAxone Therapeutic announced today positive interim results on its Phase I/IIa North American dose escalation clinical trial on Cethrin(R) for the treatment of acute spinal cord injury (SCI). The Company reported that data on safety, tolerability and neurological outcome from the six-week follow-up of the trial of Cethrin(R) at four dose levels (0.3, 1, 3 and 6 mg) indicates that this treatment is safe and well tolerated and that the functional benefit may be dose dependent.
The twelve-month study is evaluating 37 patients from 9 centers in the U.S. and Canada who suffered a complete thoracic or cervical injury (i.e. ASIA Grade A, having no sensory or motor function below the level of the spinal cord injury).
"We have now passed the most critical period of observation regarding the safety of Cethrin(R) with more than half of the patients having completed their six-month follow-up. None of the patients has shown any adverse events related to the administration of this drug and the outcome continues to be encouraging for patients who have completed the six-month follow-up," said Dr. Michael Fehlings, the lead investigator for the study. Dr. Fehlings is a Professor of Neurosurgery at the University of Toronto and holds the Krembil Chair in Neural Repair and Regeneration at Toronto Western Hospital.
The trial is not placebo controlled but has an efficacy component based on the American Spinal Injury Association's (ASIA) scale which is designed to assess sensory and motor function in patients. In this trial, 31% of patients, after six weeks, recovered some sensory and/or motor function below the level of their injury and converted from a complete injury to an incomplete injury.
"We are excited about Cethrin(R)'s excellent safety profile and the neurological outcomes observed to date," said Dr. Frank Bobe, President and CEO of BioAxone. "BioAxone is at the frontier of this new science and we are actively looking for commercial partners to join us in accelerating the development of Cethrin(R)."
Cethrin(R) is a recombinant protein that is topically delivered onto the spinal cord during decompression/stabilization surgery. "Cethrin(R) is the first of a new class of drugs that is specifically designed to penetrate cells and inhibit Rho, a signaling master switch whose activation triggers cell death and exacerbates spinal cord damage following injury," said Dr. Patrick Tremblay, Vice President of Research and Development at BioAxone.
There are currently no effective therapies for spinal cord injury and the nearly 12,000 new patients each year in North America alone. Despite significant scientific breakthroughs existing clinical interventions remain limited to reducing local inflammation of the spinal cord.
Cethrin(R)'s active ingredient, BA-210, is a recombinant protein which acts as a Rho GTPase antagonist to promote neuroprotection and neuroregeneration in the central nervous system (CNS). It was engineered by BioAxone to effectively penetrate into CNS tissue, where it has been clearly shown to elicit the rescue and repair of damaged neurons in preclinical animal models. To obtain Cethrin(R), BA-210 is mixed with a commercially available fibrin sealant, Tisseel(R), and is delivered in a single dose directly onto the dura mater of the spinal cord during decompression/stabilization surgery. Cethrin(R) was granted orphan drug status by the U.S. Food and Drug Administration (FDA) in December 2005.
About BioAxone Therapeutic
BioAxone is a privately owned neuroscience company specializing in the development and commercialization of proprietary technologies that target Rho signaling. Established in April 2000 and headquartered in Montreal, Canada, BioAxone has demonstrated expertise in recombinant protein product development and has a focused small-molecule program.
BIOAXONE THERAPEUTIC INC.