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Thread: Chronic Spinal Cord Injury - Cyberkinetics' Andara(TM) - Regeneration.

  1. #1
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    Chronic Spinal Cord Injury - Cyberkinetics' Andara(TM) - Regeneration.

    http://home.businesswire.com/portal/...69&newsLang=en

    Cyberkinetics' Andara(TM) Combination Product Yields Nerve Regeneration and Functional Recovery in Model for Chronic Spinal Cord Injury; Andara(TM) OFS PLUS SYSTEM Data Debuted at AANS Annual Meeting

    FOXBOROUGH, Mass.--(BUSINESS WIRE)--April 25, 2006--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; "Cyberkinetics") today announced that the Company's research collaborators at Indiana University and the Center for Paralysis Research at Purdue University presented study results that demonstrate - for the first time - that Cyberkinetics' Andara(TM) Oscillating Field Stimulator (OFS) PLUS System, a combination product, induced nerve regeneration and functional recovery in a preclinical model of chronic, or long-term, spinal cord injury. These new findings build on the previously demonstrated ability of Cyberkinetics' Andara(TM) OFS Device, used alone, to restore sensation and some function in a Phase Ia clinical trial of ten participants who received the device within 18 days of their injuries.

    In his presentation yesterday at the Annual Meeting of the American Association of Neurological Surgeons in San Francisco, California, Scott Shapiro, M.D., explained that these promising results were achieved in a preclinical study that examined use of the Andara(TM) OFS Device in combination with local delivery of a naturally occurring small molecule called inosine (together, the "Andara(TM) OFS PLUS System"). This system is the subject of a patent filing to which Cyberkinetics holds an exclusive, worldwide license. Dr. Shapiro is the Principal Investigator for the ongoing Phase Ib clinical trial of the Andara(TM) OFS Device and the Robert L. Campbell Professor of Neurosurgery at the Indiana University School of Medicine. Richard Borgens, Ph.D., inventor of Cyberkinetics' Andara(TM) OFS Device technology, founder of Purdue's Center for Paralysis Research, and the Mari Hulman George Professor of Applied Neurology in the School of Veterinary Medicine at Purdue, and Scott Purvines, M.D., a neurosurgeon affiliated with The Brain and Spine Center at St. Luke's Hospital in Chesterfield, Missouri, and former intern at the Indiana University School of Medicine, were co-authors on the study.

    "The need for effective treatments for spinal cord injury is urgent and we are currently studying the Andara(TM) OFS Device with the goal of making a promising treatment for acute spinal cord injuries available to surgeons as soon as possible," stated Dr. Shapiro. "The findings reported today suggest that the Andara OFS PLUS System may eventually make it possible to also restore function in the large number of chronically injured patients who suffered injuries in the past."

    "The Andara(TM) OFS Device is currently under FDA review as a Humanitarian Device for use in patients with acute spinal cord injuries and that indication represents a promising near-term revenue opportunity. We believe that the exciting preclinical results reported today provide the basis for expanding the Andara(TM) OFS market potential by using it as a delivery vehicle, not only for inosine, but for other neural repair factors as well," said Timothy R. Surgenor, President and Chief Executive Officer at Cyberkinetics. "We are also actively exploring how to move beyond the treatment of spinal cord injuries to address the other potential neurostimulator markets for the Andara(TM) OFS Device such as repair of peripheral nerve injuries, strokes and traumatic brain injuries."

    "The results reported today are a significant step in our efforts to develop novel biological approaches to the medical treatment of paralyzed people. While many emerging treatments for spinal cord injury, such as stem cells, are still in early stages of development, the Andara(TM) OFS platform could potentially bring benefit to paralyzed people sooner. We believe that there is great promise in combining OFS with a variety of neurotrophic factors, and we look forward to further investigating this approach," said Richard Borgens, Ph.D., inventor of the Andara(TM) OFS Device technology platform and co-investigator for the study.

    About the Study

    Researchers used an animal model of chronic spinal cord injury (SCI) to examine the usefulness of applying the Andara(TM) OFS PLUS System versus inosine alone at 91 days post injury. The results were referenced to a sham device control group and to historical data from using the Andara(TM) OFS Device alone. Efficacy was evaluated by measuring the ability to restore the cutaneous trunchi muscle reflex (CTM) and by analyzing for regenerating axons histologically after complete spinal cord injuries. The researchers found that the Andara(TM) OFS PLUS System and inosine groups both exhibited recovery of the CTM reflex at 60 days post-treatment, vs. no CTM recovery in the control group. Notably, the CTM recovery obtained in the Andara(TM) OFS Device PLUS group occurred in all but one subject by one month after treatment. Furthermore, the Andara(TM) OFS Device PLUS group showed statistically superior regeneration of ascending and descending nerve fibers across the injury site vs. inosine (p0.03 and p0.02, respectively) and both groups regenerated more than the controls (p0.0001 and p0.0004, respectively).

    About the Andara(TM) OFS Device and Andara(TM) OFS PLUS System

    The Andara(TM) Oscillating Field Stimulator technology platform is based upon the application of oscillating, low-voltage, direct current of electricity to the areas above and below a spinal cord injury. The Andara (TM) OFS Device stimulates the neural fibers surrounding the spinal cord to grow across the injury in order to restore sensory and motor function. Only about the size of a lipstick tube, the device is implanted and the electrical leads are attached onto the bone above and below the area of injury. The Andara(TM) OFS PLUS System includes a drug pump which delivers inosine to the area of injury. The Andara(TM) OFS Device is designed to treat acute injuries and the Andara(TM) OFS PLUS System, which is designed to be used with a number of neurotrophic factors, is being developed for long-term (chronic) injuries. The proprietary therapeutic devices are both designed to stimulate repair of central nervous system tissue and to restore sensation and motor function.

    The Andara(TM) OFS Device has already been demonstrated in Phase Ia clinical trials to regenerate neural fibers and improve or restore tactile sensation and movement in those with quadriplegia and tetraplegia due to spinal cord injury when the device is implanted within 18 days following injury. Cyberkinetics is seeking to obtain Humanitarian Use Device (HUD) Designation from the FDA to support the filing of a Humanitarian Device Exemption (HDE) in mid 2006. If approved, Cyberkinetics could begin marketing the Andara OFS Device on a limited basis as early as 2007.

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    Last edited by Leif; 04-25-2006 at 10:55 AM.

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    www.cyberkineticsinc.com

    A photo of the Andara(TM) OFS Device, a fact sheet about the Andara(TM) OFS technology and a copy of the abstract for Dr. Shapiro's talk, Inosine Versus Oscillating Field Stimulation Plus Inosine in Treating Experimental Chronic Spinal Cord Injury, are available via "Media Room" at http://www.cyberkineticsinc.com. An animation about the Andara(TM) OFS Device is available on the homepage of Cyberkinetics' website at www.cyberkineticsinc.com.

    Abstract: 2006 Mar 16

    Insoine Versus Oscillating Field Stimulation Plus Inosine in Treating Experimental
    Chronic Spinal Cord Injury

    Author(s):
    Scott A. Shapiro, MD
    Scott Purvines, MD
    Richard Borgens, PhD (Indianapolis, IN)

    Introduction: : Oscillating field stimulation(OFS) improves recovery from acute spinal cord injury
    (SCI) in animals/humans but not chronic. Inosine is a neurotrophin that is synergistic with OFS in
    acute SCI. We tested in a chronic SCI model inosine plus OFS versus inosine. Methods: Guinea
    pigs underwent a T10 hemisection with disappearance of their unilateral cutaneous trunchi muscle
    reflex(CTM). On day 91 post hemisection , 15 animals(Group 1) had a pump placed that delivered
    inosine(10mM) at 0.25 microliters/hour for 14 days. 15 animals(Group 2) had both an OFS and
    inosine pump placed. A control group of 15 animals were treated with a sham stimulator and
    pump. All animals underwent measurement of the (CTM) at 60 days and then had their cord
    exposed and injected with a 20 microliter fluroesently labeled dextran(fluouro emerald) rostral and
    (fluoro ruby )caudal to the hemisection for axon labelling to analyze for regenerating axons
    histologically. Results: The controls recovered no CTM. Group 1 recovered 23.5% of their
    preinjury CTM area (p0.001) . Group 2 recovered 27.1% of their preinjury reflex area(p0.01). The
    difference between groups 1 & 2 was a p0.14. Axon labelling demonstrated more regeneration in
    the ascending fibers in group 2 as compared to group 1 (p0.03) and both groups regenerated
    more than controls(p0.0001). Descending regeneration was significantly better in Group 2 versus
    1(p0.02) and again both were better than controls(p0.0004) Conclusions: Inosine plus OFS
    significantly improved recovery and regeneration in a chronic SCI model and is the most robust
    chronic injury treatment seen in our lab to date.

    Keywords:
    inosine
    oscillating field stimulation
    spinal cord injury
    Article ID: 34554
    http://www.cyberkineticsinc.com/cont...s/mediakit.jsp

    Also from Wikipedia regarding Inosine;

    Inosine is a molecule (known as a nucleoside) that is formed when hypoxanthine is attached to a ribose ring (also known as a ribofuranose) via a β-N9-glycosidic bond. This is a very common modified nucleoside found in tRNAs and is essential for proper translation of the genetic code in Wobble base pairs.
    Inosine is a nucleic acid important for RNA editing. A (Adenine) is converted to I (Inosine), which pairs with G (Guanine).
    Inosine is also an intermediate in a chain of purine nucleotides reactions required for muscle movements.
    It was tried in the seventies in easter countries for improving athletic performance, based in the fact that is a intermediate compound used in the muscle movements. Nevertheless the clinical trials with this purpose showed no improvement.
    Nowadays, it has been shown that inosine has neuroprotective properties. It has been proposed for administration after in stroke, because it was observed that induces axonal rewiring [1]- It has been tried also for multiple sclerosis and is currently in phase II of the trials [2].
    It produces uric acid after ingestion, which is a natural antioxidant and a peroxinitrite scavenger, which can explain the behaviour in multiple sclerosis [3](peroxynitrite has been correlated with the axons degeneration [4]).
    Currently it is being investigated by Boston Life Sciences under the name axosine

    http://en.wikipedia.org/wiki/Inosine
    Last edited by Leif; 04-25-2006 at 02:04 PM.

  3. #3
    Leif, thanks for posting this. Any news about help for chronics keeps the hope going

  4. #4
    Thanks Leif!

    This is excellent news! Glad to see Inosine back in the spotlight.

    The one catch is the OFS Plus system hasn't been tested in humans and the injury inflicted in the animal model was a hemisection. Most SCI's have contusion injuries. I wonder when human trials for this will be planned.

    Wise, is it difficult to restore the CTM muscle in rodents? In other words, does the restoration of this muscle overcome a significant hurdle?


    Group 1 recovered 23.5% of their
    preinjury CTM area (p0.001) . Group 2 recovered 27.1% of their preinjury reflex area(p0.01). The
    difference between groups 1 & 2 was a p0.14.
    Are these BBB scores? If so, how would they translate to humans.

    I wonder how much money he needs to jump start human trials using the OFS Plus system and if he'll stick with the Inosine alone or add other growth factors?

    I'm sure his research could benefit from the passage of the CRPA bill.

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    Quote Originally Posted by antiquity
    Thanks Leif!

    This is excellent news! Glad to see Inosine back in the spotlight.

    The one catch is the OFS Plus system hasn't been tested in humans and the injury inflicted in the animal model was a hemisection. Most SCI's have contusion injuries. I wonder when human trials for this will be planned.
    According to their website;

    Andara ™ OFS Device - Acute Spinal Cord Injury – HUD Application Underway.

    Andara ™ OFS PLUS System – Repair Chronic Nerve Damage – Projected Phase I, 2007-2008.

    See the first “Media Kit” link here; http://www.cyberkineticsinc.com/content/aboutus/mediakit.jsp
    Last edited by Leif; 04-25-2006 at 03:00 PM.

  6. #6
    Quote Originally Posted by antiquity
    Thanks Leif!

    This is excellent news! Glad to see Inosine back in the spotlight.

    The one catch is the OFS Plus system hasn't been tested in humans and the injury inflicted in the animal model was a hemisection. Most SCI's have contusion injuries. I wonder when human trials for this will be planned.

    Wise, is it difficult to restore the CTM muscle in rodents? In other words, does the restoration of this muscle overcome a significant hurdle?

    Are these BBB scores? If so, how would they translate to humans.

    I wonder how much money he needs to jump start human trials using the OFS Plus system and if he'll stick with the Inosine alone or add other growth factors?

    I'm sure his research could benefit from the passage of the CRPA bill.
    Antiquity,

    The cutaneous trunchi muscle reflex was developed by Andrew Blight in my laboratory at NYU in the 1980's. You know how when a fly lands on the back of the horse and the horse twitches that part of the skin so that the fly would leave. That is the CTM. Guinea pigs have this reflex and it requires a sensory signal to go from the dermatome of the particular segment up to the brainstem and a motor signal has to go back down again to that segment. So, this is a highly specific reflex that reflects both ascending and descending spinal tracts. It is actually quite difficult to get back and therefore I need to look at the paper carefully and figure how much did return and how specific the return was. But, yes, if it returned, that is very impressive and interesting, even in a hemisection model.

    Wise.

  7. #7
    Leif, you always manage to make my day with these articles

  8. #8
    This is what I don't get...

    Using neurologically hemisected hamsters is great and all, but I think making this therapy jump through the whole phase I phase II phase III phase IIII phase IIIIII phase IIIIIIIIIII FDA approval is a stall. I'm still a little new to the world of SCI, but this procedure seems to be about as invasive as a baclofen pump. By all means correct me if I'm wrong, but the side effects or any complications arising from this procedure sound like they would be within the scope of a baclofen pump implantation. What I mean by all this is that if my neurosurgeon asked me if I was willing to try this on the night of my laminectomy, I would have agreed, and I'm sure I'm not the only one. I know that when an amphibian loses an appendage, it autonomically uses a similar approach to grow back the appendage that was lost. I would just like to see a procedure like this come into practice soon.

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    Tufelhunden - Hopefully Wise can make your day even better when he has read through the papers. But I fancy the idea to put "DC" electric current trough the injured areas of the cord to stimulate axon growth with other factors as in this article. Isn’t this how the nervous system works? By DC (Direct Current - "bioelectricity") I mean. Ohm’s law is as valid here as in your fuse box in your car I believe.
    Last edited by Leif; 04-25-2006 at 05:08 PM.

  10. #10
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    Quote Originally Posted by Leif
    Ohm’s law is as valid here as in your fuse box in your car I believe.
    Yes, it is. The principles of conduction, resistance, and distance would apply to any electrical circuit, including the human nervous system.

    Significant difference between hemisection and contusion.
    Last edited by Schmeky; 04-25-2006 at 06:27 PM.

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