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Thread: SYGNIS Receives Orphan Drug Designation from the European Commission for AX200 in the

  1. #1

    SYGNIS Receives Orphan Drug Designation from the European Commission for AX200 in the

    SYGNIS Receives Orphan Drug Designation from the European Commission for AX200 in the treatment of Spinal Cord Injury
    Heidelberg (ots) -

    -Second indication for AX200 given Orphan Drug status

    SYGNIS Pharma AG (News/Aktienkurs) (Frankfurt: LIO; ISIN DE0005043509; Prime Standard), today announced that it has received Orphan Drug designation from the European Commission for AX200 in the treatment of Spinal Cord Injury (SCI). This follows the positive recommendation that SYGNIS received from the EMEA in September.

    Orphan Drug designation can be granted for a product that is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union. During the development phase certain incentives are given to the developing company to facilitate the product's registration and market authorization. These incentives include reductions in fees, an accelerated registration procedure. Furthermore, for a period of up to 10 years market exclusivity is granted once the product is approved.

    A spinal cord injury (SCI) is damage or trauma to the spinal cord which interrupts communication of the brain with body regions below the site of injury. Spinal cord injuries are predominantly caused by accidents and, in the majority of cases, result in life-long loss of control of motor functions and sensation. After the primary injury to the spinal cord, a cascade of events leads to progressive loss of tissue which may further deteriorate the patient's prognosis. There is a large demand for novel therapies in view of the poor treatment options currently available.

    more...

    http://www.finanznachrichten.de/nach...injury-007.htm

  2. #2
    This looks promising, and its for acutes and CHRONICS!!

    Good find Manouli!

    Lets keep an eye on this one, and see what the clinical trials show.

  3. #3
    About AX200

    AX200 is a biological molecule, developed by SYGNIS for the treatment of neurodegenerative diseases. In the indication of stroke it is the most advanced drug candidate in SYGNIS' product pipeline. In summer 2007 the Phase IIa of the clinical development was successfully completed. AX200 is an endogenous protein. As part of the body's own protective action the production of AX200 is boosted after brain damage. If the molecule is given as a medication it increases the existing endogeneous response to the damage. SYGNIS pursues a dual neurotherapeutic approach in the development of AX200 or the treatment of neurodegenerative diseases: AX200 stops neuronal cell death in the acute phase of the disease while at the same time stimulating the regeneration of the already damaged CNS through the stimulation of neurogenesis as well as arteriogenesis and the reorganisation of neuronal networks. Besides stroke, AX200 is currently in preclinical testing for further neurodegenerative indications such as Amyotrophic Lateral Sclerosis (ALS) and Spinal Cord Injuries (SCI)...
    Looks good. Unfortunately it's still in preclinical testing for SCI.

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    Senior Member KIM's Avatar
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    Look alike Neraxo

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    Senior Member KIM's Avatar
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    Sorry, Neuraxo

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