BioAxone Therapeutic Study Demonstrates Positive Interim Results for Spinal Cord Injury

Six-week Follow-up Results of Phase I/IIa Trial Show Safety, Tolerability

and Neurological Outcome of Cethrin(R)



Nov 27, 2006, 00:00 ET from BIOAXONE THERAPEUTIC INC.

    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.
     About Cethrin(R)
     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.
 
 

SOURCE BIOAXONE THERAPEUTIC INC.
    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.
     About Cethrin(R)
     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.
 
 SOURCE BIOAXONE THERAPEUTIC INC.