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Thread: Neuraxo Biotec Info

  1. #11
    Senior Member kilgore's Avatar
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    Susanne,
    Thanks for your willingness to share!
    As you complete your acute injury studies, please be constantly mindful of how those efforts can be used in chronic injuries. I'm sure you know that we chronics are your biggest fans, and are looking to you to help reduce the physical and emotional suffering we experience every day.

  2. #12
    susanne,
    do you work on the same area like prof.hans w.
    müller,ore search he in a other direction?
    thank you
    dyonisos

    be dazed and confused

  3. #13
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    hallo susanne,
    you are talking about "acute complete patients". which patients do you exactly mean? complete acutes with a bruised spinal cord? comp. acutes with partial severed spinal cord, or even pat. with complete severed spinal cord? in the last case you would have the best possibility to define an outcome, i think. do you have any plans to use tubes to lead outsprouting axons to their target?
    gruß migu

  4. #14
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    Hi Migu,
    we have not defined our final inclusion parameters yet. Since we are developing a quite acute treatment you are absolutely right, "completeness" is hard to define at so early stages of injury. We are working together with experienced clinicians to give the best possible outcome predictions by combination of imaging techniques and electrophysiological measurements. But the prediction of (natural) outcome will never be 100% and we are aware of that. In such a study like we are planning efficacy can be shown in the end only in comparison to the standard treatment group and with a qite large total number of patients enrolled.
    My best wishes to you.
    Susanne

  5. #15
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    Hey Dyonisos,
    sorry for my late reply but yes, Prof. Müller was my tutor during my thesis and he is the founder of Neuraxo.
    Best wishes
    Susanne

  6. #16
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    news on neuraxos homepage:
    Orphan Medicinal Product Designation granted for NEURAXO`s CNS recovery drug Cordaneurin® (EMEA/OD/014/04)

    Düsseldorf, Germany, October 04, 2004; NEURAXO Biotec GmbH, a biopharmaceutical company focused on the treatment of nervous system injuries, received the Orphan Medicinal Product Designation (OMPD) for the development of Cordaneurin®, its lead investigational drug for treatment of spinal cord injury by EMEA (European Medicines Agency). Clinical trials for Cordaneurin® will be performed for the indication: Treatment of traumatic spinal cord injuries. First patients will start with Clinical Phase I/IIa mid 2005, the first EU launch being foreseen in 2007.

    The Orphan Medicinal Product Designation (OMPD) significantly facilitates the registration of Cordaneurin®, a potential drug for hitherto incurable CNS injuries.

    The OMPD status, granted in all 25 European Union countries, allows a centralized registration procedure enabling a quicker registration. In comparison to standard clinical trials, the study designs can be adapted, i.e. shortened, permitting Cordaneurin® a faster time to market with less investment on part of NEURAXO. During the studies a free of charge scientific advice/protocol assistance and other incentives will be provided by the Authorities.

    Josef Hofer, PhD, directing R&D: "The Orphan Drug Regulation guarantees a 10 years market exclusivity for the Marketing Authorization of Cordaneurin® within the European Community with respect to similar drugs. This gives us a considerable head start to potential competitors".

    Prof. Hans Werner Müller, scientific founder of NEURAXO concludes: "NEURAXO's R&D is now eligible for being sponsored by European Programs, Community Projects and other incentives from the European and national health organizations. All these facts will significantly support NEURAXO to expedite its clinical development programs."

    Following the recent arrangement between EMEA and FDA regarding the possibility of a Parallel Scientific Advice (PSA), now the registration of an EMEA granted product in the US is much easier. For this NEURAXO Biotec aims also to initiate a clinical development program in the United States.

    Profile NEURAXO Biotec GmbH:

    NEURAXO Biotec is a biopharmaceutical company focused on the treatment of nervous systems injuries. NEURAXO`s proprietary key technology, the Regeneration Promoting Treatment, world-wide is the first investigational therapy aiming at the regeneration of injured nerves following their natural nerve tract.

  7. #17

    Exclamation

    Hi,

    has anyone heard any more about their progress. Dyonisis, would you mind contacting susanne again

    cheers

  8. #18
    Senior Member KIM's Avatar
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    Ads32
    Check with them here
    http://www.neuraxo.de/1.0.html?&L=0&L=2

  9. #19
    Quote Originally Posted by Ads32
    Hi,

    has anyone heard any more about their progress. Dyonisis, would you mind contacting susanne again

    cheers
    dear ads32
    please have patience. they working hard,you will see it soon.....
    be dazed and confused

  10. #20
    Quote Originally Posted by dyonisos
    dear ads32
    please have patience. they working hard,you will see it soon.....
    Hi,

    please can you expand on this?

    I often email them but no reply. do you think they will reach their goal with chronics

    many thanks

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