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Thread: Neotherapeutics clinical trial of AIT-082 in subacute spinal cord injury

  1. #1

    Neotherapeutics clinical trial of AIT-082 in subacute spinal cord injury

    AIT-082 or neotrofin® is being tested at Ranchos Los Amigos in Downey CA and also at Gaylord Rehabilitation Institute in Wallingford, Connecticut ( ). According to their web site on June 29, 2001, three patients has already been started in the trial. They will be receiving the drug orally for 12 weeks.

    [This message was edited by Wise Young on August 18, 2001 at 02:02 PM.]

  2. #2

    NeoTherapeutics announce allowance of patent for nerve regeneration and neuroprotective capabilities of Neotrofin

    NeoTherapeutics, Inc. announced allowance of a new U.S. patent covering Neotrofin's ability to regenerate and protect neurons in the central and peripheral nervous system. Neotrofin is currently under evaluation in a pivotal clinical study for Alzheimer's disease, and in phase 2 clinical studies for Parkinson's disease and spinal cord injury. Pre-clinical studies have demonstrated that Neotrofin is neuroprotective, induces neuronal sprouting and causes the proliferation of stem cells. Previously, the United States Patent and Trademark Office granted NeoTherapeutics five patents covering the Company's technology platform, which includes NeoTherapeutics' lead drug candidate, Neotrofin. 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.

  3. #3

    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

    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.

  4. #4
    Senior Member X-racer...'s Avatar
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    Jul 2001
    Eugene, OR
    Abstract View
    M.S. Glasky1*; J.M. Conner2; M.H. Tuszynski2
    1. NeoTherapeutics Inc, Irvine, CA, USA
    2. Neurosciences, UCSD, La Jolla, CA, USA

    AIT-082 is a purine analog that crosses the blood brain barrier after oral administration. To determine whether AIT-082 influences growth factor levels in the intact brain, adult female Fisher 344 rats were administered AIT-082 at 0, 3, 30, 300 or 3000mg/kg/day in drinking water for 7 days. NGF and BDNF protein levels were measured in parietal cortex, frontal cortex, spinal cord, basal forebrain, brainstem, hippocampus, and striatum using a specific ELISA. AIT-082 slightly but significantly increased BDNF levels in spinal cord (Control: 0.2470.018; 3mg/kg: 0.270.01; 30mg/kg: 0.2970.012*; 300mg/kg: 0.3850.021*; 3000mg/kg: 0.380.009*), hippocampus (Control: 2.240.116; 3mg/kg: 2.5320.072*; 30mg/kg: 2.630.041*; 300mg/kg: 2.4870.069*; 3000mg/kg: 3.0140.067*), striatum (Control: 0.760.054; 3mg/kg: 0.9780.06*; 30mg/kg: 1.130.052*; 300mg/kg: 1.1930.055*; 3000mg/kg: 1.3020.050*) and parietal cortex (Control: 0.2380.023; 3mg/kg: 0.2900.023; 30mg/kg: 0.3240.034; 300mg/kg: 0.3480.03*; 3000mg/kg: 0.4830.039*), but not in frontal cortex, basal forebrain, or brainstem. AIT-082 also induced a slight, but significant, dose-dependent increase in NGF levels in hippocampus (Control: 1.3370.052; 3mg/kg: 1.6080.051*; 30mg/kg: 1.6920.076*; 300mg/kg: 1.5370.086*; 3000mg/kg: 1.8580.046*). Thus, an increase in NGF and BDNF levels in some CNS regions are observed after AIT-082 administration. Mechanisms underlying this change remain to be determined. It is possible that indirect factors, e.g., AIT-082-induced motor hyperactivity, could result in the observed changes. Studies to address this possibility are underway.
    Supported by: NeoTherapeutics Inc.

  5. #5
    Senior Member jb's Avatar
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    Jan 2002

    ? dr. young

    i hope i'm doing this right. i asked about the stem cell transplants in russia earlier this month. i had this drug in july. i finished mid-october. i don't know what others have gotten back if anything. i have. i've been on the neotherapeutics webpage. i have also contacted them. no one has gotten back to me. mayber they can't discuss it till all the info is in. this puts me in the outfield. i'm not walking. i want to enter other trials but can't because i was in one. i think i plateued. do you know anything about this drug's success/failure? do you know of any trials that'll take someone who already completed one?

  6. #6
    jb, I swear that I answered your question earlier but it seems not to have gotten to the web site.

    Most companies cannot provide clinical trial data while the trial is running and some have a policy not to provide the data even after the trial has ended. However, they should have the courtesey to respond to your phone calls and do their best to answer your questions.

    You do have a right to know the design of the clinical trial and they should be working hard to make sure that you understand the trial, i.e. what is the eligibility criterion, how long the trial will go, what the followup period, what data supports the trial, and what the outcome measures are. This is informed consent and they should be happy to provide you with this information.

    At the present, I suggest that you wait until until this trial ends before you join another trial. People who participate in a clinical trial also have an obligation to complete the trial. The trial is no good if people drop out. It wastes all the effort that you and they have gone to, to test the therapy. If AIT-082 does not work, it is really important to know. On the other hand, I want to emphasize that recovery takes time. It may be working.

    If you received the therapy in October, that means you are less than 6 months after injury. Even though you may have reached a plateau, you are likely to recover more function in the coming months.

    What other treatments are you thinking of?


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