>>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 - news, NEOTW - news) 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.<<
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Cheers, Tuck |
