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April 22, 2014
10:03 EDTGEVASynageva mentioned cautiously by Seeking Alpha contributor
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January 26, 2015
07:36 EDTGEVASynageva announecs dosing of patients concerned with SBC-103 in Phase 1/2 study
Synageva announced dosing with SBC-103 in patients with mucopolysaccharidosis IIIB has begun as part of a Phase 1/2 study. In addition, the FDA recently granted SBC-103 Fast Track designation. The trial will enroll approximately nine patients, two years of age or greater but less than 12 years of age, with definitive diagnosis of MPS IIIB and developmental delay. Patients will be treated in one of three different dosing cohorts with every other week intravenous administrations of SBC-103 for 24 weeks. Patients who meet qualifying criteria may continue therapy with SBC-103 for an extended treatment period that will last up to 128 weeks. The primary endpoint of the trial is safety and tolerability of intravenous administration of SBC-103 in patients with MPS IIIB. The study will also determine the effects of dosing with SBC-103 on the onset, magnitude, and reversibility of changes in levels of total HS in cerebral spinal fluid, serum, and urine as well as measure the effects of neurocognitive and developmental function and change in brain structures as assessed by magnetic resonance imaging. Exploratory biomarkers, SBC-103 concentration in CSF, MPS IIIB disease characteristics, symptoms, and quality of life will also be measured.

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