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Key Activities

Key achievements 2012

• Zymenex devoted the company's Research and Development efforts to the recombinant enzyme, Lamazym, for treatment of the Lysosomal Storage Disease, alpha-Mannosidosis and the recombinant enzyme Galaczym for Krabbe disease.
• Zymenex has successfully completed and evaluated a 12 month dose/response Phase 2a clinical trial and a 6 month follow-up Phase 2b clinical trial in 9 patients. The aim of the trials, which took place at the Department of Clinical Genetics, Copenhagen University Hospital,Denmark, was to confirm the chosen weekly minimum effective dose of 1 mg/kg and to validate the clinical effect of repeated i.v dosing.
• Positive changes from baseline after 18 months of dosing have been demonstrated in the primary measured clinical and biochemical endpoints.

Statistically significant changes were demonstrated in oligosaccharide levels in serum, in the functional tests: 3 Minute Stair Climb (+39 steps, p=0.004) and 6 Minute Walk Test (+71 meters, p=0.009) as well as in the Leiter-R test of intellectual capacity (+0.5, p=0.022). The forced vital capacity (FVC), lung function test showed a marked increase (+9.2%, p=0.157).