MONTREAL, July 10 /PRNewswire/ - BioAxone Therapeutic announced today that it has completed its targeted patient enrollment of the Phase I/IIa North American clinical trial of Cethrin(R) for the treatment of acute spinal cord injury (SCI). Cethrin(R), a recombinant protein-based inhibitor of Rho signaling, is co-delivered with a fibrin sealant and administered once directly onto the surface of the spinal cord during spinal decompression surgery. Results of the trial are expected in the fall of 2006.
BioAxone's announcement follows a presentation at the 24th Annual National Neurotrauma Symposium in St. Louis, Missouri, by the clinical trial's lead investigator Dr. Michael Fehlings, a professor of neurosurgery at the University of Toronto and holder of the Krembil Chair in Neural Repair and Regeneration based at Toronto Western Hospital. The presentation was entitled "New Developments in the Early Management of Acute Spinal Cord Injury: Updates from the STACIS & Cethrin(R) Trials".
Dr. Fehlings indicated that the last patient had been enrolled for the Cethrin(R) trial and that "Cethrin(R) offers a novel and promising regenerative approach to enhance functional recovery of patients suffering from spinal cord injury. We have seen no adverse events related to the administration of Cethrin(R) at this stage of the study and clinically the results look interesting."
The trial is an open-label safety and pharmacokinetic study in which Cethrin(R) was administered to patients with acute thoracic or cervical spinal cord injuries. The study, conducted with 37 patients in 9 centers in the U.S. and Canada, is designed to evaluate the safety and tolerability of Cethrin(R). The protocol entails four escalating doses and includes patients with complete thoracic or cervical injury. Although the trial is not placebo controlled, it has an exploratory efficacy component based on the American Spinal Injury Association's (ASIA) classification scale, designed to detect improvements in sensory and motor function of patients.
"An acute injury to the spinal cord has a dramatic and sudden impact on the life of a person experiencing it," said Dr. Frank Bobe, President and CEO of BioAxone. "There is no available treatment for this condition, and Cethrin(R) is currently the leading product candidate in the world undergoing human clinical trials. In North America alone, there are 12,000 new patients each year whose only hope is to prevent further damage to their spinal cord. Cethrin(R) is the first of a new generation of drugs that specifically targets the cellular response to an acute spinal cord injury. BioAxone is at the frontier of this new science and we are all eagerly awaiting the results of this first clinical trial, expected in the fall of 2006."
Clinical centers participating in this trial are: University of Virginia Health System, Charlottesville, VA. (1 patient); Mayfield Clinic and Spine Institute, Cincinnati, OH. (3 patients); Hopital du Sacre-Coeur de Montreal, Montreal, QC. (7 patients); Thomas Jefferson University Hospital, Philadelphia, PA. (5 patients); Barrow Neurological Associates, Phoenix, AZ. (11 patients); University of Washington Harborview Medical Center, Seattle WA. (1 patient); Toronto Western Hospital (6 patients) and Sunnybrook Health Sciences Centre (1 patient) Toronto, ON; and Vancouver Hospital and Health Sciences Center, Vancouver, BC. (2 patients).
Cethrin(R) has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) in December 2005. 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 has been designed by BioAxone to effectively penetrate into CNS tissue, where it has been clearly shown to elicit the rescue and repair of damaged neurons in BioAxone's preclinical research models.
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.
For further information, please contact:
Dr Frank Bobe,
President and CEO
BioAxone Therapeutic Inc.
BIOAXONE THERAPEUTIC INC.