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  1. #1
    Senior Member Max's Avatar
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    Exclamation Drug Shows Promise in Spinal Cord Injury Treatment/Cethrin

    Drug Shows Promise in Spinal Cord Injury Treatment
    04.17.07, 12:00 AM ET
    TUESDAY, April 17 (HealthDay News) -- A drug called Cethrin shows promise in treating people with spinal cord injury (SCI), according to a study by American and Canadian researchers. Cethrin inhibits Rho, a signaling master switch that, when activated, triggers cell death and increases damage after SCI. Tests in animals with SCI have found that Cethrin inhibits cell death and promotes neural regeneration.
    This one-year study looked at the use of Cethrin (a recombinant protein) formulated with a fibrin sealant in 37 patients who had just suffered an SCI that left them with no sensory or motor function below the area of the injury.
    All the patients had an "A" grade injury as ranked by the American Spinal Injury Association (ASIA). Grades of injury go from A through E. An "A" is the most serious while "E" is normal.
    After the patients had surgical decompression/reconstruction, the researchers started treatment with Cethrin, an average of 53 hours after the injury occurred. The patients received increasing doses of the drug (0.3, 1.0, 3.0 and 6 milligrams) administered extradurally to the injured spinal cord. The patients were assessed at various points over a year.
    The study found that at six weeks, 30.6 percent of the patients improved by one or ASIA grades of injury. At six months, 28 percent of patients improved by one or more ASIA grades. Five patients improved to "C" and two improved to "D." One patient died from acute respiratory distress syndrome.
    The study, which was funded by BioAxone Therapeutique of Montreal and Boston Life Sciences Inc., was presented Monday at the annual meeting of the American Association of Neurological Surgeons, in Washington, D.C. The findings from this Phase I/II study warrant moving on to a prospective randomized trial of Cethrin, the researchers said.
    More information

    http://www.forbes.com/forbeslife/hea...out603694.html

  2. #2
    Senior Member Max's Avatar
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    Arrow New hope for spinal cord injury sufferers

    New hope for spinal cord injury sufferers

    Medical Studies/TrialsPublished: Wednesday, 18-Apr-2007 Printer Friendly Email to a Friend

    Spinal cord injury (SCI) is one of the most significant forms of neurotrauma with major economic and social impact.

    Every year, nearly 12,000 individuals in the United States and Canada, mostly young adults, sustain a SCI. According to the Centers for Diseases Control and Prevention (CDC), SCI costs an estimated $9.7 billion each year in the United States alone. Although there are some early pharmacological and surgical interventions that may diminish the severity of SCI, the overall impact of these treatments remains minimal. "There is an urgent need for effective therapies to help restore neurological function in patients with acute SCI," said Michael Fehlings, MD, PhD, FRCSC, FACS, head of the Krembil Neuroscience Center at the University Health Network in Toronto and a professor of Neurosurgery at the University of Toronto. Dr. Fehlings is leading a trial conducted in Canada and the United States, sponsored by BioAxone Therapeutique (Montreal, Canada), and more recently, Boston Life Sciences, Inc. to examine a novel treatment for individuals with SCI.
    The findings of this study, Results of the Cethrin Phase I/IIa Prospective Clinical Trial of a Rho Inhibitor for the Treatment of Acute Spinal Cord Injury, were presented by Dr. Fehlings during the 75th Annual Meeting of the American Association of Neurological Surgeons in Washington, D.C. Co-authors are Nicholas Theodore, MD, James Harrop, MD, Gilles Maurais, MD, Charles Kuntz, MD, Christopher Shaffrey, MD, Brian Kwon, MD, Jens Chapman, MD, Albert Yee, MD, Patrick Tremblay, PhD, and Lisa McKerracher, PhD.
    Without medical intervention, axons in the adult central nervous system cannot regenerate following SCI. Research, however, has shown the potential for regrowth of damaged axons. Recovery of function depends upon the severity of the initial injury. It is important that treatment is undertaken as quickly as possible because there is less chance of regeneration the longer the duration of the injury.
    Researchers in Canada and the United States, led by Dr. Fehlings, are investigating the use of a novel Rho inhibitor, Cethrin?, (a recombinant protein) formulated with a fibrin sealant in patients with acute SCI. This drug has been shown to inhibit cell death and promote neural regeneration in animal models of SCI. Rho is a signaling master switch whose activation triggers cell death and increases damage after SCI.
    Thirty-seven patients with acute SCI were enrolled in the one-year study at nine sites across Canada and the United States. All patients were classified with American Spinal Injury Association (ASIA) A SCI. That means they suffered a complete thoracic or cervical injury (i.e. having no sensory or motor function below the level of the SCI). ASIA grades are designated from A through E, with 'A' designating complete SCI, and 'E' being normal. Grades 'B' through 'D' designate decreasing levels of neurological involvement.
    After patients underwent surgical decompression/reconstruction, treatment was initiated. This occurred within five days of the SCI incident, with the average time being 53 hours. Escalating doses of Cethrin? (0.3, 1.0, 3.0, and 6 mg.) were administered extradurally to the injured spinal cord. All adverse events were recorded and neurological outcomes were assessed using ASIA standards at 0, 1.5, 3, 6 and 12 months. The following outcomes were noted:
    • There were no serious adverse effects related to Cethrin?.
    • At 6 weeks, 30.6 percent of patients improved by one or more ASIA grades.
    • The 6-month patient data showed that 28 percent of patients improved by one or more ASIA grades. Five patients improved to ASIA C and two patients improved to ASIA D.
    • One patient with a thoracic SCI died from acute respiratory distress syndrome (ARDS).
    "This preliminary research shows great promise for restoring some neurological function for patients with new cases of acute SCI. The positive findings in this Phase I/II trial provide the impetus to proceed to a prospective randomized trial," stated Dr. Fehlings.
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  3. #3
    Frank Bobe, Executive Vice President and Chief Business Officer of Boston Life Science, presented at the Work 2 Walk Symposium. He was formerly at Bioaxone. Boston Life Science licensed Cethrin from Bioaxone.

    I couldn't take complete notes but from what I heard and remember, the trial involved 41 paients and 31% of hte patients converted from ASIA A to ASIA B or higher. They also showed a dose dependence of neurological response. They compared patients that received 0.3 to 6.0 mg. At 6 months, they had a 67% conversion rate. I am unsure of the followng number apparently they had a 19% conservation from A to C or D at 6 months. If so, this is even more impressive than the original report. Particularly a conversion from ASIA A to D is quite rare. For them to have two patients out of 41 do so is quite impressive, in my opinion. They may get even better results when they treat all the patients with high dose.

    Wise.

  4. #4
    Senior Member Jeremy's Avatar
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    Doctor Tries New Injection To Fight Paralysis

    Doctor Tries New Injection To Fight Paralysis

    Tuesday, May 01, 2007 - 10:52 AM

    http://www.wtvq.com/midatlantic/tvq/...5-01-0009.html

    There are currently no effective therapies for spinal cord injuries. But a protein injection may help some patients walk again.

    Two years ago, Michelle Robinson was on her way home from work when she was hit by a car.

    “All I remember is hearing a loud screeching noise and I remember going, flying up in the air," Michelle said.

    The accident left the 42-year-old mother paralyzed. Now she hopes an experimental drug will put her back on her feet.

    "It appears that this actually does improve their prognosis," said James Harrop, a neurosurgeon.

    Harrop is testing the novel drug called Cethrin to treat spinal cord injuries.

    “It’s a paste or a jelly that you sort of just spread onto the spinal cord with a little applicator, like a syringe," he said.

    Doctors apply the protein during standard decompression surgery to stabilize the spine. The idea is to stop nerve cell death that includes days to weeks after the injury occurs.


    “Inside the cell, there’s a nucleus which is controlling sort of this, the auto-regulator of the cell and what it’s doing is it’s telling the cell we don’t want you to function anymore," Harrop said.

    Cethrin is designed to interfere with that message by seeping through the spinal cord membrane to cells at the injury site.

    “It goes into the cell and it says ‘wait a minute’. I don’t want you guys going down that path anyways, I want youto stop and I want you to start repairing the cell," Harrop said.

    Early trials show the protein therapy is safe. And the results are promising. Michelle says she is both excited and hopeful the new therapy will work for her.

    “I say those words because Dr. Harrop told me that he was very hopeful that, you know, maybe one day I would be able to walk again, so I’m very hopeful also."

    Doctors caution that Cethrin, also called BA210, is not a magic bullet. But in the study, 31 percent of patients regained some function after being injected with the drug. The study is still enrolling patients. For more information and study sites, visit www.clinicaltrials.gov and search for BA210.

    About 253,000 Americans are living with a spinal cord injury. Roughly 11,000 new cases occur every year.

  5. #5
    Quote Originally Posted by Jeremy
    Doctor Tries New Injection To Fight Paralysis

    Tuesday, May 01, 2007 - 10:52 AM

    http://www.wtvq.com/midatlantic/tvq/...5-01-0009.html

    There are currently no effective therapies for spinal cord injuries. But a protein injection may help some patients walk again.

    Two years ago, Michelle Robinson was on her way home from work when she was hit by a car.

    “All I remember is hearing a loud screeching noise and I remember going, flying up in the air," Michelle said.

    The accident left the 42-year-old mother paralyzed. Now she hopes an experimental drug will put her back on her feet.

    "It appears that this actually does improve their prognosis," said James Harrop, a neurosurgeon.

    Harrop is testing the novel drug called Cethrin to treat spinal cord injuries.

    “It’s a paste or a jelly that you sort of just spread onto the spinal cord with a little applicator, like a syringe," he said.

    Doctors apply the protein during standard decompression surgery to stabilize the spine. The idea is to stop nerve cell death that includes days to weeks after the injury occurs.


    “Inside the cell, there’s a nucleus which is controlling sort of this, the auto-regulator of the cell and what it’s doing is it’s telling the cell we don’t want you to function anymore," Harrop said.

    Cethrin is designed to interfere with that message by seeping through the spinal cord membrane to cells at the injury site.

    “It goes into the cell and it says ‘wait a minute’. I don’t want you guys going down that path anyways, I want youto stop and I want you to start repairing the cell," Harrop said.

    Early trials show the protein therapy is safe. And the results are promising. Michelle says she is both excited and hopeful the new therapy will work for her.

    “I say those words because Dr. Harrop told me that he was very hopeful that, you know, maybe one day I would be able to walk again, so I’m very hopeful also."

    Doctors caution that Cethrin, also called BA210, is not a magic bullet. But in the study, 31 percent of patients regained some function after being injected with the drug. The study is still enrolling patients. For more information and study sites, visit www.clinicaltrials.gov and search for BA210.

    About 253,000 Americans are living with a spinal cord injury. Roughly 11,000 new cases occur every year.
    quote:

    Two years ago, Michelle Robinson was on her way home from work when she was hit by a car.

    This is great because she is chronic and they try it on her. Even if she gets back bladder control will be fantastic.
    manouli

  6. #6
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    Cethrin clinical trial

    I have just checked - the clinical trial does not seem to concern chronics??
    gretchen 1

  7. #7
    Dr. Frank Bobe of Boston Life Sciences was a speaker at the Working 2 Walk symposium last week. Boston Life Sciences recently acquired Cethrin from BioAxone. Dr. Bobe spoke about the Cethrin trial. Kate's notes about his talk are here. I will be posting the video of his talk tonight or tomorrow.

    Gretchen, you're right, it's for acutes only. The trial began in 2004 so Michelle must have gotten it when she was first injured.

  8. #8
    Senior Member artsyguy1954's Avatar
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    Cool

    Good for Michelle if it works for her. Cethrin certainly hasn't made me walk again. Last time I checked. (Unless I am walking in my sleep.)
    Step up, stand up for:
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  9. #9
    Senior Member Max's Avatar
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    Arrow Paralysis shot

    Paralysis shot
    var wn_last_ed_date = getLEDate("Apr30,2007,5:00 PM EST"); document.write(wn_last_ed_date);April 30, 2007 05:00 PM EDT
    NATIONAL - Right now there are no effective therapies for spinal cord injuries. But a protein injection may help some patients walk again.
    Two years ago, Michelle Robinson was on her way home from work when she was hit by a car, "All I remember is hearing a loud screeching noise and I remember going, flying up in the air."
    The accident left the 42-year-old mother paralyzed. Now she hopes an experimental drug will put her back on her feet. Dr. James Harrop says, "It appears that this actually does improve their prognosis."
    Dr. Harrop is testing the novel drug called cethrin to treat spinal cord injuries. "It's a paste or a jelly that you sort of just spread onto the spinal cord with a little applicator, like a syringe."
    Doctors apply the protein during standard decompression surgery to stabilize the spine. The idea is to stop nerve cell death that continues days to weeks after the injury occurs.
    Dr. Harrop says, "Inside the cell, there's a nucleus which is controlling sort of this, the auto-regulator of the cell and what it's doing is it's telling the cell we don't want you to function anymore."
    Cethrin is designed to interfere with that message by seeping through the spinal cord membrane to cells at the injury site. Dr. Harrop says, "It goes into the cell and it says 'Wait a minute. I don't want you guys going down that path anyways, I want you to stop and I want you to start repairing the cell.'"
    Early trials show the protein therapy is safe. And the results are promising.
    Michelle told us she's both "excited" and "hopeful" the new therapy will work for her. "I say those words because Dr. Harrop told me that he was very hopeful that, you know, maybe one day I would be able to walk again, so I'm very hopeful also."
    Doctors caution that Cethrin, also called BA-210, is not a magic bullet. But in the study, 31 percent of patients regained some function after being injected with the drug.
    The study is still enrolling patients. For more information and study sites visit clinicaltrials.gov and search for BA-210.
    Information is also available by loging onto http://www.clinicaltrials.gov/, and typing the term BA-210 in the search box.
    http://www.wistv.com/Global/story.as...9&nav=menu36_3

  10. #10
    Senior Member Scott Buxton's Avatar
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    I have an unscientific hunch that Cethrin will be one part of the "combination" that will make more connections. That and Lithium.

    I forget which med, but I heard just recently of a med that will help dissolve the glial "scar". Then Lithium will help the stems to proliferate and the Cethrin will keep cells fom dying. Hmmm.


    Scott.

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