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Thread: Drug Shows Promise in Spinal Cord Injury Treatment/Cethrin

  1. #11
    Senior Member Jeremy's Avatar
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    Research Utilizing A New Protein May Hold Promise For Thousands Of People Living With Spinal Cord Injury By Partially Restoring Neurological Function
    Main Category: Neurology / Neuroscience News
    Article Date: 03 May 2007 - 12:00 PDT
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    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 , will be presented by Dr. Fehlings, 3:15 to 3:30 p.m. on Monday, April 16, 2007, 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, t reatment 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. Fivepatients 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.

    Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 6,800 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system, including the spinal column, spinal cord, brain and peripheral nerves.

  2. #12
    Senior Member Max's Avatar
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    QSV Biologics, Ltd. and, Alseres Pharmaceuticals, Inc., Sign Contract for cGMP Manufa

    QSV Biologics, Ltd. and, Alseres Pharmaceuticals, Inc., Sign Contract for cGMP Manufacture of Cethrin(R) for Spinal Cord Injury

    EDMONTON, July 10 /CNW/ - QSV Biologics, Ltd (QSV), a North Americanbased biologics CMO located in Edmonton, Canada, and Alseres Pharmaceuticals,Inc., (Alseres) a publicly traded (Nasdaq: ALSE) Central Nervous Systemdiagnosis and treatment company located in Hopkinton, Massachusetts, U.S.A.,announced today the signing of a contract for the process development and cGMPmanufacturing of Cethrin(R) for spinal cord injury. QSV will be responsiblefor technology transfer, process development and cGMP manufacture of phaseIIb/III clinical trial material in their commercially licensed cGMPmanufacturing facility. Cethrin(R), licensed by Alseres from BioAxoneTherapeutics, is a Rho inhibitor that stimulates axon regeneration. Graeme Macaloney PhD, PEng, QSV President & CEO said: "Thisfirst-in-field therapy for acute spinal cord injury is an excitingbreakthrough, given that there are no approved alternatives. We are proud tobe providing the manufacture of this important spinal cord therapeutic forAlseres, which has received Orphan Drug designation from the US-FDA". "We are pleased to commence our relationship with QSV Biologics for thecGMP manufacturing of Cethrin," commented Mark Pykett, President and COO ofAlseres. "As Alseres prepares to initiate its Phase IIb/III clinical trials inacute spinal cord injury later this year, we believe that QSV providestechnical know-how and value to this program-critical process." Alseres Pharmaceuticals, Inc. (ALSE), previously Boston Life Sciences, isengaged in the clinical development of diagnostic and therapeutic products forcentral nervous system (CNS) disorders. Cethrin(R), ahttp://www.newswire.ca/en/releases/a.../10/c5237.html

  3. #13
    Senior Member Max's Avatar
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    Arrow Seeking a makeover, firm changes its name

    Seeking a makeover, firm changes its name

    By Jeffrey Krasner, Globe Staff | September 3, 2007
    Call it the extreme corporate makeover.
    While some companies embrace their past, others want people to forget what they've done.
    It's a strategy that seems to work well for biotechnology companies that have lost too much money, angered too many investors, or gone too long without delivering a product.
    For example: Boston Life Sciences Inc.
    Over the past 10 years, the biotech firm has turned in the sixth-worst investment performance of any Massachusetts company, losing 94 percent of its share price. The shares closed Friday at $2.39.
    So a few months ago, Boston Life Sciences changed its name to Alseres Pharmaceuticals Inc.
    It's a better name, said chief executive Peter G. Savas, since it comes from the Latin word "to grow together." Alseres primary mission is to develop a drug, Cethrin, that has shown promising results in repairing spinal cord injuries that cause permanent paralysis.
    Savas said the Boston Life Sciences name had become a liability. People who became interested in the firm's experimental spinal cord treatment would lose interest when they heard that the company behind it was Boston Life Sciences, which had lost $153 million since it was founded in 1992.
    "I want to distance myself from it," he said.
    The name change is only the most visible part of the transformation Savas has overseen since he joined the firm in 2004. He's revamped management, added scientific advisers, narrowed the company's focus, and moved corporate headquarters from Newbury Street, where Boston Life Sciences had, incongruously, set up shop, to Hopkinton, a proper suburban location for a development-stage biotech.
    Boston Life Sciences was founded by Dr. Marc E. Lanser, who had a clever idea: Instead of spending millions on labs, clinical trials and employees, he created a virtual company that farmed out most of its scientific work. He predicted the savings would allow the company to pursue more drug candidates and improve its odds of developing a blockbuster treatment.
    But the story played out in a way that's all too familiar to many biotech investors. Promising early-stage technology never made it to market. A sharp spike in share prices in early 2000 quickly faded, and the stock languished in the single digits. The company faced delisting of its shares from the Nasdaq Stock Market. Investors ultimately forced Lanser out. That's when Savas arrived.
    The new chief executive said Boston Life Sciences had been spread too thin, with programs to develop a diagnostic for a type of Parkinson's disease, a nerve regeneration treatment, and a test for attention-deficit hyperactivity disorder. The goal now is to advance some of those programs to the point where a big pharmaceutical or biotech company will want to collaborate on development and marketing, and eventually take over some or one of the programs.
    The spinal cord treatment remains the crown jewel. If successful, Alseres would retain control of it and build its own sales f,,,,,,,,,,,

    http://www.boston.com/business/globe...s_name?mode=PF

  4. #14

    Alseres Pharmaceuticals' Announces Expansion of the Cethrin(R) Acute Spinal Cord Inju

    Alseres Pharmaceuticals' Announces Expansion of the Cethrin(R) Acute Spinal Cord Injury (SCI) Phase I/IIA Clinical Trial

    Monday September 24, 9:55 am ET
    Data Safety Monitoring Board (DSMB) Authorizes Enrollment of Cervical Patients at Current Highest Authorized Dosage Level


    HOPKINTON, Mass., Sept. 24 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals (Nasdaq: ALSE - News) today announced that its independent Data Safety Monitoring Board (DSMB) has unanimously authorized expanding the Company's Phase I/IIa clinical trial in acute spinal cord injury (SCI) to allow subjects with cervical SCI to be treated with a 9 mg dose of Cethrin®. This recommendation is based on the safety analyses of data from thoracic subjects who have been treated at the 9mg dosage level and overall evaluation of safety of the drug in this clinical trial to date.

    more:

    http://biz.yahoo.com/prnews/070924/nem069.html?.v=19

  5. #15
    Super Moderator Sue Pendleton's Avatar
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    This is such a wonderful hurdle to get over! A drug that helps enough that they are willing to use it on upper level injuries regardless of infections or whatever that might come. I always thought it was backwards using drugs on T levels first when those going on ventilators were more in need of even a little recovery to drop the vent. YEA!

    Quote Originally Posted by manouli
    Alseres Pharmaceuticals' Announces Expansion of the Cethrin(R) Acute Spinal Cord Injury (SCI) Phase I/IIA Clinical Trial

    Monday September 24, 9:55 am ET
    Data Safety Monitoring Board (DSMB) Authorizes Enrollment of Cervical Patients at Current Highest Authorized Dosage Level


    HOPKINTON, Mass., Sept. 24 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals (Nasdaq: ALSE - News) today announced that its independent Data Safety Monitoring Board (DSMB) has unanimously authorized expanding the Company's Phase I/IIa clinical trial in acute spinal cord injury (SCI) to allow subjects with cervical SCI to be treated with a 9 mg dose of Cethrin®. This recommendation is based on the safety analyses of data from thoracic subjects who have been treated at the 9mg dosage level and overall evaluation of safety of the drug in this clinical trial to date.

    more:

    http://biz.yahoo.com/prnews/070924/nem069.html?.v=19
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  6. #16
    Alseres expands Cethrin Phase I/IIa clinical trial

    28th September 2007
    By Staff Writer

    Alseres Pharmaceuticals has reported that an independent data safety monitoring board has unanimously authorized expanding its Phase I/IIa clinical trial in acute spinal cord injury to allow subjects with cervical SCI to be treated with a 9mg dose of Cethrin.

    more:
    http://www.pharmaceutical-business-r...1-B4EF7D86F4CE

  7. #17
    Senior Member Norm's Avatar
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    This is only for fresh injuries. How will it help us?
    Last edited by Norm; 09-29-2007 at 09:44 PM.
    "Some people say that, the longer you go the better it gets the more you get used to it, I'm actually finding the opposite is true."

    -Christopher Reeve on his Paralysis

  8. #18
    Norm, yes, although it may be applicable in chronics as well.
    ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

  9. #19
    Senior Member Max's Avatar
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    Arrow Drug can help patients heal from spinal cord injuries

    Drug can help patients heal from spinal cord injuries
    9/20/2007 3:43 PM
    By: Ivanhoe Broadcast News
    According to the Spinal Cord Injury Information Network, there are about 11,000 new spinal cord injuries each year. Car accidents have been responsible for nearly 50 percent of spinal cord injuries since 2000, and falls have been the second most common cause of spinal cord injuries. Currently, about 253,000 Americans are living with a spinal cord injury.
    Dr. Michael Fehlings from Toronto Western Hospital is studying a new drug to treat spinal cord injuries soon after they happen. The drug, called Cethrin, is applied during surgery to the injury site in a fibrin glue type of material. Cethrin is a recombinant protein that is made through artificial DNA technology. The protein inhibits Rho, a key pathway that triggers cell death and increases damage after a spinal cord injury.
    "You apply [Cethrin] directly to the damaged spinal cord and then the medication penetrates the damaged spinal cord," Fehlings said.
    Cethrin is still under study, but early results look promising. Results from a one-year study of the drug in 37 patients were presented in April, 2007 at the annual meeting of the American Association of Neurological Surgeons in Washington, D.C. All patients in the study had "A" grade injuries, which are the most serious. Injuries are graded from A to E, with A being the most serious and E being the least serious.
    Patients received Cethrin an average of 53 hours after their injury occurred. After six months, 28 percent of patients improved by one or more grades. Five patients improved to a "C" grade, and two improved to a "D" grade.Typically, there is some recovery that occurs after an injury, but the rates of recovery are quite low, in the range of 5 percent to 10 percent.

    http://www.news8austin.com/content/h...192303&SecID=2

  10. #20
    Quote Originally Posted by Scott Buxton
    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.
    Dr.Young,

    Is Cethrin still being looked at by the China SCI Network as a possible third part to the UCBC+Lithium combination? Also, in terms of the glial 'scar', in your studies with ucbc, do axons manage to cross the 'scar' without a problem? Thanks in advance.

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