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September 23, 2013
07:12 EDTALNYAlnylam announces positive results from ALN-TTRsc Phase 1 trial
Alnylam Pharmaceuticals announced positive interim results from its Phase I clinical trial of ALN-TTRsc. Results show that ALN-TTRsc administration led to robust, consistent, and statistically significant knockdown of serum TTR protein levels of up to 94%. In addition, knockdown of TTR, the disease causing protein in ATTR, was found to be rapid, dose dependent, and durable. To date, ALN-TTRsc has been found to be generally safe and well tolerated in this study. These human data are the first to be presented for Alnylamís proprietary GalNAc-siRNA conjugate delivery platform, enabling subcutaneous dosing of RNAi therapeutics with a wide therapeutic index, and demonstrate human translation for this platform. Moreover, these results establish a new benchmark for consistent TTR knockdown of approximately 90% for RNA therapeutics in development for the treatment of ATTR. Upon completion of this Phase I trial, the company expects to start a pilot Phase II clinical study of ALN-TTRsc in FAC patients in late 2013 and, assuming positive results, plans to start a pivotal Phase III trial with ALN-TTRsc in FAC patients in 2014
News For ALNY From The Last 14 Days
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October 1, 2015
13:00 EDTALNYAlnylam recent weakness a buying opportunity, says Piper Jaffray
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07:01 EDTALNYGenzyme opts into ALN-AT3 Hemophilia Program
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September 30, 2015
07:11 EDTALNYLeerink to hold a roundtable
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September 28, 2015
14:49 EDTALNYAlnylam granted summary judgment by U.S. district court in patent dispute
Alnylam Pharmaceuticals announced that Chief Judge Patti Saris of the U.S. District Court for the District of Massachusetts granted Alnylam's summary judgment motion in an inventorship dispute, holding that Professor Brenda Bass, Distinguished Professor at the University of Utah, is not a co-inventor of certain patents, termed the Tuschl II patents, jointly owned by co-defendants the Max Planck Society, UMass, Massachusetts Institute of Technology, and the Whitehead Institute for Biomedical Research, and exclusively licensed to Alnylam. In 2011 Utah sued Alnylam, Max Planck, UMass, MIT, and Whitehead alleging that Dr. Bass was either the sole or a co-inventor of the Tuschl II patents, seeking correction of inventorship as well as unspecified monetary damages. In 2015 Utah dropped their sole inventorship claim. The Court found that there was no collaboration between Dr. Bass and Dr. Tuschl, which is a pre-requisite for co-inventorship, and also granted the defendants' motion for summary judgment on Utah's state law claims. While Utah can appeal this ruling, Alnylam remains firm in its belief that the inventorship of the Tuschl II patents as stated in the issued patents is correct, the company said.
11:14 EDTALNYAlnylam OLE data has positive read through to Phase 3 trial, says Piper Jaffray
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08:05 EDTALNYAlnylam reports new results from ongoing Phase 2 OLE study of patisiran
Alnylam Pharmaceuticals and collaborators announced new results from the company's ongoing Phase 2 open-label extension study of patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR-mediated amyloidosis patients with familial amyloidotic polyneuropathy. In collaboration with investigators at The Scripps Research Institute and Misfolding Diagnostics, Inc., patisiran administration was shown to reduce pathogenic, misfolded TTR monomers and oligomers in FAP patients in the Phase 2 OLE study. Specifically, patisiran administration resulted in a rapid and sustained reduction of approximately 90% in serum non-native conformations of TTR. Since NNTTR is pathogenic in ATTR amyloidosis, these results provide direct mechanistic evidence supporting the therapeutic hypothesis that TTR knockdown has the potential to result in clinical benefit. In addition, Alnylam presented complete 12-month data from all 27 patients initially enrolled in the patisiran OLE study, showing a mean 3.1-point decrease in the modified Neuropathy Impairment Score at 12 months as well as sustained mean maximum reductions in total serum TTR of 91% for over 18 months. Moreover, patisiran administration was found to be generally well tolerated out to 21 months of treatment. Alnylam's ongoing Phase 2 OLE study is an open-label, multi-center trial designed to evaluate the long-term safety and tolerability of patisiran administration in FAP patients that were previously enrolled in a Phase 2 study. Patisiran is being administered once every 3 weeks at a dose of 0.3 mg/kg by intravenous infusion. The study is measuring a number of clinical endpoints every six months, including mNIS+7 which is an evaluation of muscle weakness, sensory and autonomic function, and nerve conductance, where neuropathy progression leads to an increased score over time. The change in the mNIS+7 measurement from baseline to 18 months is the primary endpoint in the company's ongoing Phase 3 APOLLO trial of patisiran in FAP patients.
September 22, 2015
11:04 EDTALNYAlnylam weakness on 'Hillary-Scare' a buying opportunity, says Piper Jaffray
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