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Thread: BioAxone announces first patient treatment in acute spinal cord injury trial

  1. #1
    Senior Member Max's Avatar
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    BioAxone announces first patient treatment in acute spinal cord injury trial

    BioAxone announces first patient treatment in acute spinal cord injury trial
    MONTREAL, Feb. 7 /CNW Telbec/ - BioAxone Therapeutics Inc., a
    biopharmaceutical company, has announced the first patient administration of
    Cethrin(R) in the Phase I/IIa clinical trial for the treatment of acute spinal
    cord injury. The first patient was administered Cethrin by Dr. Nicholas
    Theodore, Neurosurgeon at St. Joseph's Hospital & Medical Center, Phoenix,
    Arizona.
    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 rising 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 8 sites in Canada and the US.
    "This is a very important trial in the field of spinal cord injury. The
    novel therapeutic agent and the innovative delivery process represent
    significant milestones in our search to find better ways of treating patients
    with acute spinal cord injury", said Dr. Nicholas Theodore.
    "Cethrin(R) represents a unique approach for this treatment, and the
    procedure we have developed minimizes risk to patients because it is
    non-invasive", said Henry E. Khouri, PhD, MBA, Vice President, Clinical
    Development at BioAxone. "We are pleased to have enrolled
    http://www.newswire.ca/en/releases/a.../07/c1273.html



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  2. #2
    Senior Member Max's Avatar
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    Wise! This info also should be made sticky here without delay!

    Since it gives immeadiate access to acutes.....Hope it will not take 9 month (like it was with Proneuron trials in USA)......Hope Nurse Rachedlol will agree on this one!

    For further information: Dr. Henry E. Khouri, Vice-President of Clinical
    Development, BioAxone Therapeutic Inc., Info@bioaxone.com, (514) 282-9990;
    Source: Charles Pitts, Oroalliance, cpitts@oroalliance.com, (514) 984-5614,
    (877) 990-9044; Visit: www.bioaxone.com



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  3. #3
    Senior Member Max's Avatar
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    Thank you Wise......& Nurse?



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    Senior Member Max's Avatar
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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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  5. #5
    Senior Member Max's Avatar
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    Exclamation Wise

    This used to be sticky on this forum

    Same with procord trials-since it gave immediate info to families of newly injured sci

  6. #6
    Senior Member Max's Avatar
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    BioAxone Appoints Patrick Tremblay Vice President Research & Development

    BioAxone Appoints Patrick Tremblay Vice President Research & Development
    Tuesday November 29, 8:54 am ET
    MONTREAL, Nov. 28 /PRNewswire/ - BioAxone announced today that it has appointed Dr. Patrick Tremblay Vice President Research & Development (R&D), effective December 1, 2005. Dr. Tremblay joins BioAxone from Neurochem Inc. where he served as Director of Pharmacology. He succeeds BioAxone's CSO, Dr. Lisa McKerracher, who remains an active member of the Company's Board of Directors.
    "Since initiating its clinical phase I/IIa trial for acute spinal cord injury in February of this year, BioAxone has focused its preclinical efforts on using Rho inactivation antagonists as a new therapeutic approach for the treatment of age-related macular degeneration and glaucoma. Dr. Tremblay's broad expertise in neurodegenerative diseases and proven leadership in biopharmaceutical R&D will be key in assuring that BioAxone advances this program to IND status before the end of 2006", said Dr. Bobe, BioAxone's President and CEO. After obtaining his Ph.D. in molecular biology from the University of Montreal in 1990, Dr. Tremblay spent three years as a postdoctoral research fellow at the Max Planck Institute in Germany where he worked with Dr. Peter Gruss, current president of the Max Planck Society. He then moved to the University of California in San Francisco to work on neurodegenerative diseases caused by prions with Dr. Stanley Prusiner, Nobel Laureate of Medicine and Physiology (1997). In 2001, Dr. Tremblay joined Neurochem, where he was responsible for the development of small therapeutic molecules for the treatment of amyloid diseases such as Alzheimer's disease.
    About BioAxone BioAxone Therapeutic Inc. is a privately owned neuroscience company specializing in the development and commercialization of proprietary technologies that target Rho signaling.


    http://biz.yahoo.com/prnews/051129/m....v=5&printer=1

  7. #7
    Senior Member Max's Avatar
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    BioAxone spinal cord injury treatment receives orphan drug status

    BioAxone spinal cord injury treatment receives orphan drug status

    The FDA has granted orphan drug status to BioAxone Therapeutic's drug candidate Cethrin which is currently in a phase I/IIa clinical trial for patients with acute thoracic and cervical spinal cord injuries.

    http://www.pharmaceutical-business-r...0-7FA1C95B875F

  8. #8
    Senior Member artsyguy1954's Avatar
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    Hi Max, I am part of the first stage of the Bioaxone trial. (Using a fairly low dosage of Cethrin) I am still not sure if this drug is actually supposed to give you function back or just prevent too much nerve cell death at the injury site. ARTSYGUY

  9. #9
    Senior Member Max's Avatar
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    BioAxone Therapeutic announces patients completed the 6 week follow-up in the Phase I

    BioAxone Therapeutic announces patients completed the 6 week follow-up in the Phase I/IIa Trial of Cethrin(R) for the treatment of acute spinal cord injury
    Monday August 28, 8:30 am ET Report available in the fall of 2006
    MONTREAL, Aug. 28 /PRNewswire/ - BioAxone Therapeutic announced today that all patients enrolled in its Phase I/IIa North American clinical trial of Cethrin® for the treatment of acute spinal cord injury (SCI) have completed their 6 week follow-up visit. All essential information has been collected for the clinical trial report that will be available in the fall. Patients will also have additional follow-ups at 3, 6 and 12 months to monitor the progression of the treatment.


    http://biz.yahoo.com/prnews/060828/mo485.html?.v=1

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