This is a Phase 0/1 study of MS patients to determine the safety and potential efficacy of a novel, small human peptide designated as JM-4. The study will involve treatment for 5-7 days with JM-4 to determine the effects of Gadolinium(+) lesion number and volume in the brains of patients.
This study is the first study of JM-4 in patients with Multiple Sclerosis and is intended to show safety and potential efficacy in changing the size and/or number of GAD(+) lesions in the brain. The initial dose level of 1 mg/kg/ will establish safety of JM-4 treatment after 5-7 days of treatment via intravenous infusion over 30 minutes daily in3-5 patients with Multiple Sclerosis. MRI examinations will be conducted prior to treatment with JM-4 and 8 days after the initiation of treatment for the purpose of quantitating GAD(+) brain lesions. Once initial safety is established, the next group of 3-5 patients will receive 4 mg/kg/ of JM-4 daily for 5-7 days via 30 minute intravenous infusions, with MRI scans conducted prior to treatment and 8 days after the initial dose of JM-4. Once safety is established in this cohort of patients, a third group of patients may receive 9 mg/kg/ of JM-4 daily for 5-7 days via 30 minute infusions, with MRI scans conducted prior to the initial treatment and 8 days after the initial treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Novel small human peptide derived from erythropoietin
Number of patients with treatment-related adverse events
To determine the incidence of adverse events and any abnormal laboratory values
Time frame: From initial dose through 8 days after initiation of dosing
Change in GAD(+) brain lesions measured via MRI scan
Measurement of the number and size of GAD(+) brain lesions from baseline to post-dosing 8 days after initiation of treatment
Time frame: From initial dose through 8 days after initiation of dosing
Changes in the ability of patients to complete a timed 25-foot walk
To determine changes in timed 25 foot walk prior to treatment or 8 days after treatment
Time frame: From initial dosing through 8 days post-initiation of dosing
Treatment-induced changes in Expanded Disability Status Score in patients
Measurement of Expanded Disability Status scores in patients prior to treatment and after completion of treatment
Time frame: Prior to initial dose through 8 days post-initial treatment
Changes in neurological exam
Neurological examination of patients to check for optic nerve changes and vision changes
Time frame: Prior to initial dose through 8 days post-initial treatment
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