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Thread: Cethrin(R) receives Orphan Drug Status

  1. #1
    Senior Member Max's Avatar
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    Cool Cethrin(R) receives Orphan Drug Status

    Cethrin(R) receives Orphan Drug Status

    MONTREAL, Dec. 12 /CNW Telbec/ - BioAxone Therapeutic Inc. announcedtoday that the U.S. Food and Drug Administration (FDA) has granted Orphan DrugStatus to its drug candidate Cethrin(R), which is currently in a phase I/IIaclinical trial for patients with acute thoracic and cervical spinal cordinjuries. "The Orphan Drug Status, granted for rare diseases afflicting less than200,000 patients per year in the U.S., provides BioAxone with considerablestrategic advantages for accelerating the development of its lead drugcandidate Cethrin(R) by extending its patent protection, reducing clinicaldevelopment costs and facilitating regulatory filings in other countries" saidDr. Frank Bobe, President and Chief Executive Officer of BioAxone."Recruitment for our phase I/IIa trial is on schedule and completion isexpected by June of 2006". There is currently no effective treatment for acute spinal cord injury, acondition that can lead to complete and permanent loss of sensory and motorfunctions and require life-long specialized care for the vast majority ofpatients. In addition to creating significant health care costs, spinal cordinjury has a dramatic impact on the quality of life of patients and those whocare for them. At BioAxone, in vitro as well as in vivo studies havedemonstrated the neuro-protective and neuro-regenerative properties ofCethrin(R), underscoring the potential benefits of this treatment for patientswith acute spinal cord injury. About BioAxone http://www.newswire.ca/en/releases/a.../12/c5826.html

  2. #2
    ...provides BioAxone with considerable strategic advantages for accelerating the development of its lead drug candidate Cethrin(R) by extending its patent protection, reducing clinical development costs and facilitating regulatory filings in other countries"
    Good news!

  3. #3
    Senior Member mk99's Avatar
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    Dr. Young, does this news change in any way the possibility of using Cethrin as part of a combo trial? Maybe through the China SCINet?
    "Oh yeah life goes on
    Long after the thrill of livin is gone"

    John Cougar Mellencamp

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    Senior Member mk99's Avatar
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    bumping for Dr. Young's response when he has a moment
    "Oh yeah life goes on
    Long after the thrill of livin is gone"

    John Cougar Mellencamp

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