Results 1 to 8 of 8

Thread: NeoTherapeutics Expands Neotrofin(TM) Trials in Spinal Cord Injury -- Two "Centers of Excellence" in the treatment of spinal cord injury added

Hybrid View

Previous Post Previous Post   Next Post Next Post
  1. #1
    Senior Member Jeremy's Avatar
    Join Date
    Jul 2001
    Location
    Canada
    Posts
    588

    NeoTherapeutics Expands Neotrofin(TM) Trials in Spinal Cord Injury -- Two "Centers of Excellence" in the treatment of spinal cord injury added

    NeoTherapeutics Expands Neotrofin(TM) Trials in Spinal Cord Injury -- Two "Centers of Excellence" in the treatment of spinal cord injury added


    Story Filed: Wednesday, August 22, 2001 9:15 AM EST

    IRVINE, Calif., Aug 22, 2001 /PRNewswire via COMTEX/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT; NEOTW) announced today that it has expanded its Neotrofin(TM) spinal cord injury trial to include Thomas Jefferson University Hospital (Pennsylvania) and Craig Rehabilitation Center (Denver). Seven patients are currently receiving Neotrofin: five at Rancho Los Amigos Hospital in Los Angeles and one each at Craig Rehabilitation Hospital and Thomas Jefferson University Hospital. The four currently active centers are expected to enroll a total of 30 to 40 patients for 12 weeks of dosing.

    Craig Hospital in Denver has long been recognized as a premier national 'Center of Excellence' in the specialty of rehabilitation and research for patients with spinal cord injury and acquired brain injury. Craig Hospital has treated more than 23,000 patients since 1956 -- more than any other single facility in the world. The principal investigator at this site is Daniel Lammertse, M.D.

    Thomas Jefferson University Hospital, in affiliation with the Magee Rehabilitation Hospital, is designated as one of the nation's 18 regional Research Spinal Cord Injury Centers and a Center of Excellence in the treatment of spinal cord injury. Located just outside Philadelphia, the center has treated more than 2,500 patients. The principal investigator at this site is Anthony Burns, M.D.

    "We are pleased to have four of the leading centers for spinal cord injury participating in this clinical study," said F. Jacob Huff, M.D., Vice President, Medical Affairs at NeoTherapeutics. "Craig Rehabilitation Hospital, Rancho Los Amigos and Thomas Jefferson University are three of the eighteen regional Centers of Excellence for treatment of spinal cord injury in the United States, and Gaylord Hospital in Wallingford, Connecticut, has a long tradition of providing high quality patient rehabilitation."

    "The expansion of our Neotrofin clinical trials into spinal cord injury and Parkinson's disease reflects the broad range of activity the drug has demonstrated in pre-clinical neuro-degenerative models," stated Rajesh C. Shrotriya, M.D., President and Chief Operating Officer of NeoTherapeutics. "We have compelling pre-clinical data showing neuro-protection and nerve regeneration potential in the brain, the spine and the peripheral nervous system. Our clinical trial program for Neotrofin continues to expand to reflect the growing number of potential applications for our lead drug."

    In this 12-week open-label study, patients with sub-acute, complete spinal cord injury will receive Neotrofin for 12 weeks, and will be evaluated at regular intervals. In addition to extensive assessments for tolerance and safety, the Standard Neurological Classification of Spinal Cord Injury (SNCSCI) - manual motor exam score will be used as the primary evidence of preliminary efficacy. Secondary efficacy measures include the American Spinal Injury Association (ASIA) impairment scale (ASIA-IS), Functional Independence Measure (FIM) and SNCSCI-sensory exam.

    The Christopher Reeve Paralysis Foundation estimates that there are approximately 250,000 spinal cord injured individuals (SCI) living in the United States. Sixty percent are first affected between 16 and 30 years of age, and ninety percent of SCI individuals survive and have near normal life spans. There are approximately 10,000 new spinal cord injury cases per year. Initial hospitalization lasts 100 days, on average, and lifetime costs for individuals with SCI average $600,000. Current clinical practice recommends the early use of high doses of methylprednisolone for 24 to 48 hours after injury, but the effects of this treatment are limited, and there are no specific FDA-approved treatments for spinal cord injury.

    NeoTherapeutics seeks to create value for stockholders through the development of central nervous system drugs by its neurology division, in-licensing and development of anti-cancer drugs through its NeoOncoRx subsidiary, and the licensing out of new drug targets through its NeoGene Technologies subsidiary. The Company's most advanced drug, Neotrofin(TM), is currently being developed for Alzheimer's disease and other neurodegenerative diseases, such as Parkinson's disease and spinal cord injury. For additional information visit the Company's web site at www.neotherapeutics.com.

    This press release may contain forward-looking statements regarding future events and the future performance of NeoTherapeutics that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission.

  2. #2
    That is great. Please note that Neotherapeutics has a phase 2 trial going for Parkinson's disease as well. It provides more details about the dosing that they are using... escalating to 1000 mg twice a day. According to their web site:

    March 29, 2001

    Company Press Release

    NeoTherapeutics Launches Parkinson's Disease Phase 2 Clinical Trial

    First patient to be enrolled in a 12-week study of Neotrofin(TM) in patients with Parkinson's disease

    IRVINE, Calif., March 29 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT, NEOTW) announced today that it has begun a 12-week, double-blind, placebo-controlled phase 2 study of Neotrofin in Parkinson's disease. The first patient will be enrolled by Daniel Truong, M.D., principal investigator at the Parkinson's and Movement Disorder Institute at Long Beach Memorial Medical Center.

    This marks the third indication for which Neotrofin has entered clinical trials. Neotrofin has been administered to over 1,100 patients suffering from Alzheimer's disease, and, based on the excellent safety profile and signs of improvement in behavior and cognition at higher dose levels, the Company plans to begin a pivotal trial in Alzheimer's disease next month. On March 26, 2001, NeoTherapeutics announced the initiation of a phase 2 clinical trial in subacute spinal cord injured patients.

    ``I am pleased to be a part of the first clinical trial of Neotrofin in Parkinson's disease,'' said Daniel Truong, M.D., Principal Investigator at the Parkinson's and Movement Disorder Institute at Long Beach Memorial Medical Center. ``Neotrofin in preclinical studies increased nerve growth factors that may protect against the type of neuronal damage seen with Parkinson's disease. The drug's possible neuroregenerative effects provide another mechanism of benefit in this progressively disabling disease.''

    ``Recent research has shown that nerve growth factors have reversed functional disabilities of animals with Parkinson-like disease models,'' stated Stephen W. Jenkins, M.D., a board-certified neurologist and medical monitor for NeoTherapeutics. ``Nerve growth factors have been shown to be decreased in the brains of Parkinson's disease patients. Because delivery of these factors to the brain is difficult due to their large size and their inability to cross the blood-brain barrier, they cannot be easily and directly replaced. Neotrofin is a small molecule that has been shown to cross the blood-brain barrier and to raise the level of several nerve growth factors in the brain. These characteristics hold promise for delaying progression and possibly improving symptoms of Parkinson's disease.''

    ``In contrast to the fetal stem cell transplant work that has received so much attention lately, Neotrofin uses the body's own tools to repair and rebuild nerves in the brain,'' stated Rajesh C. Shrotriya, President of NeoTherapeutics. ``Our drug activates nerve growth factors, which in addition to helping repair nerves, cause the proliferation of stem cells that already exist in the brain. Additional growth factors stimulated by Neotrofin may then cause the differentiation and maturation of these new stem cells into new neurons, which are necessary to repair the damage done by neurodegenerative conditions such as Parkinson's disease.''

    Patients participating in this trial will receive doses of Neotrofin escalating from 250 mg to 1000 mg twice a day for twelve weeks. In addition to extensive assessments of tolerance and safety, the Unified Parkinson's Disease Rating Scale (UPDRS)-part III (Motor Scale) will be used as the primary measure of preliminary efficacy. Several other Parkinson's disease rating scales will used as secondary efficacy measures.

    Parkinson's disease is one of the major neurodegenerative disorders affecting more than one million patients in North America alone. The principal hallmarks of Parkinson's disease are slowness of movement, rigidity and tremor. Although current treatments provide some symptomatic relief, Parkinson's disease progresses inexorably, often over 10 to 20 years, to severe immobility and a bedridden state.

    NeoTherapeutics is a biopharmaceutical company focused on the development of drugs for unmet medical needs. The Company's most advanced drug, Neotrofin(TM), is currently being developed for Alzheimer's disease and other neurodegenerative diseases, such as Parkinson's disease and spinal cord injury. NeoGene Technologies, Inc., a subsidiary of NeoTherapeutics, is engaged in functional genomics research. A second subsidiary, NeoOncoRx, Inc., is engaged in the development of anticancer drugs. For additional Company information, visit NeoTherapeutics' web site at www.neotherapeutics.com.

    This press release may contain forward-looking statements regarding future events and the future performance of NeoTherapeutics that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission.


    Contacts:
    MEDIA RELATIONS
    Jon Siegal
    Ronald Trahan Associates (RTA) Inc.
    (508) 647-9782, ext. 15

    INVESTOR RELATIONS
    John McManus
    NeoTherapeutics, Inc.
    (949) 788-6700, ext. 247

  3. #3
    Senior Member Norm's Avatar
    Join Date
    Jul 2001
    Location
    Media, PA
    Posts
    1,560

    Whats this mean?

    "patients with sub-acute, complete spinal cord injury"

  4. #4

    Norm

    Check out the Trial forum where the treatment and the protocol is described. Wise.

  5. #5
    Senior Member giambjj's Avatar
    Join Date
    Jul 2001
    Location
    Auburn, AL,USA
    Posts
    1,866

    sub acute

    Means fairly early after injury (1 month or so). More time than that would be chronic.

  6. #6
    The neotrofin trial stipulates within 2 weeks after injury. Wise.

  7. #7
    Senior Member Norm's Avatar
    Join Date
    Jul 2001
    Location
    Media, PA
    Posts
    1,560

    Why?

    Why wouldn't they want to try it on someone like me 19 years post, that way they will know if it works or not? I haven't changed in 15 years. Rather than a fresh injury that may walk anyway, without the drug?

  8. #8
    Senior Member mk99's Avatar
    Join Date
    Jul 2001
    Location
    toronto, canada
    Posts
    3,494

    Trials Forum doesn't work

    Gives an error message when I try to go into Trials.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •