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April 2, 2014
08:08 EDTALNYAlnylam receives positive opinion for orphan drug designation ALN-TTRsc
Alnylam Pharmaceuticals announces that the European Medicines Agency Committee for Orphan Medicinal Products has adopted a positive opinion recommending ALN-TTRsc for designation as an orphan medicinal product for the treatment of transthyretin-mediated amyloidosis. ALN-TTRsc is currently in a pilot Phase 2 clinical trial for the treatment of ATTR patients with TTR cardiac amyloidosis; this study is aimed at evaluating the tolerability of ALN-TTRsc in approximately 15 patients. In addition, the study will assess preliminary clinical activity as measured by knockdown of serum TTR levels and additional exploratory tests, such as cardiac imaging, circulating cardiac biomarkers, 6-minute walk test, New York Heart Association classification, and measures of heart failure symptoms and quality of life. The company expects to present data from the Phase 2 trial in late 2014. Patients completing the Phase 2 trial will be eligible to participate in an open-label extension study for further assessment of general tolerability and clinical activity with long-term dosing; the ALN-TTRsc Phase 2 OLE study is expected to be initiated in mid-2014. Assuming positive results, Alnylam expects to begin a Phase 3 trial in TTR cardiac amyloidosis patients by the end of 2014.
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July 22, 2014
08:03 EDTALNYAlnylam receives USPTO Notice of Allowance for Manoharan 478 patent
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07:22 EDTALNYAlnylam to hold a webinar
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July 15, 2014
07:25 EDTALNYAlnylam to hold a roundtable
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