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March 18, 2013
08:05 EDTALNYAlnylam initiates phase I study for subcutaneously delivered RNAi therapeutic
Alnylam Pharmaceuticals announced that it has initiated dosing in its Phase I clinical trial with ALN-TTRsc, an RNAi therapeutic targeting transthyretin for the treatment of TTR-mediated amyloidosis. The Phase I trial of ALN-TTRsc is being conducted in the U.K. as a randomized, double-blind, placebo-controlled, single- and multi-dose, dose-escalation study, enrolling up to 40 healthy volunteer subjects. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of subcutaneously administered ALN-TTRsc. Secondary objectives include assessment of clinical activity of the drug as measured by serum TTR levels. Alnylam expects to present data from this trial in mid-2013. Upon completion of the Phase I trial, the company plans to start a Phase II clinical study of ALN-TTRsc in FAC patients by the end of 2013 and, assuming positive results, expects to start a pivotal trial for ALN-TTRsc in FAC patients in 2014.
News For ALNY From The Last 14 Days
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May 20, 2015
07:04 EDTALNYAlnylam receives orphan drug designation for revusiran
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May 19, 2015
11:03 EDTALNYAlnylam transthyretin amyloidosis treatment designated for FDA orphan status
Alnylam's revusiran was designated by the FDA for orphan drug status as a treatment of transthyretin amyloidosis. Reference Link
07:28 EDTALNYUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
May 17, 2015
15:24 EDTALNYAlnylam files ALN-AAT trial application, reports positive results in primates
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May 12, 2015
07:52 EDTALNYLeerink to hold a tour
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