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Data Safety Monitoring Board recommends continuation of BioAxone's phase I/IIa clinical trial with its lead product Cethrin(R) (BA-210) in acute spinal cord injury

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  • Data Safety Monitoring Board recommends continuation of BioAxone's phase I/IIa clinical trial with its lead product Cethrin(R) (BA-210) in acute spinal cord injury

    Data Safety Monitoring Board recommends continuation of BioAxone's phase I/IIa clinical trial with its lead product Cethrin(R) (BA-210) in acute spinal cord injury
    MONTREAL, June 6 /CNW Telbec/ - BioAxone Therapeutic Inc. announced today
    that an independent Data Safety Monitoring Board (DSMB) has reviewed the
    safety data for the first six patients in its phase I/IIa clinical trial with
    BA-210 in acute spinal cord injury. The DSMB's unanimous recommendation was
    that BioAxone continue the trial without any modifications. This interim
    review by the DSMB was prospectively specified in the original protocol and
    was based on the review of the safety data from at least 5 patients who have
    completed a minimum of 3 weeks of assessments following treatment with 0.3 mg
    of BA-210. The DSMB's recommendation has allowed BioAxone to move forward with
    the clinical protocol as planned and initiate patient treatment with a higher
    dose of BA-210, namely 1.0 mg.
    Dr. Henry E. Khouri, Vice President of Clinical Development said, "We are
    pleased with the safety profile of BA-210 obtained in patients up to this
    point. This successful review from third-party physicians reinforces our
    confidence for the development of BA-210 in acute spinal cord injury."
    The phase I/IIa clinical trial is a multinational study in which up to 48
    patients with acute spinal cord injury will be administered Cethrin(R). The
    study is designed to evaluate the safety and pharmacokinetics of escalating
    doses of Cethrin(R), following a single extra-dural administration during
    surgery for acute thoracic and cervical spinal cord injury. The patients will
    be recruited from about 10 sites in Canada and the US.
    "This recommendation represents excellent progress of our lead drug
    candidate, Cethrin(R), and shows that we are on track to reach all our
    milestones", said Dr. Frank Bobe, President & CEO of BioAxone.
    The DSMB is comprised of three independent medical experts and was
    established by BioAxone as part of the Company's compliance with good clinical
    practices guidelines. The DSMB is responsible for monitoring the safety of
    patients participating in the phase I/IIa clinical trial and for reviewing the
    safety data throughout its duration.

    http://www.newswire.ca/en/releases/a.../06/c8025.html



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