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May 13, 2014
08:01 EDTALNYAlnylam announces results from ongoing phase 1 trial of ALN-AT3
Alnylam Pharmaceuticals announced top-line results from its ongoing Phase 1 trial of ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin in development for the treatment of hemophilia and rare bleeding disorders. These top-line results are being presented at the World Federation of Hemophilia 2014 World Congress being held May 11 – 15, 2014 in Melbourne, Australia. In Part A of the Phase 1 study, human volunteer subjects received a single subcutaneous dose of ALN-AT3 and, per protocol, the maximum allowable level of AT knockdown was set at 40%. Initial results show that a single, low subcutaneous dose of ALN-AT3 at 0.03 mg/kg resulted in an up to 28-32% knockdown of AT at nadir that was statistically significant relative to placebo. This led to a statistically significant increase in peak thrombin generation, that was temporally associated and consistent with the degree of AT knockdown. ALN-AT3 was found to be well tolerated with no significant adverse events reported. With these data, the company has transitioned to the Multiple Ascending Dose Part B of the study in moderate-to-severe hemophilia subjects. Consistent with previous guidance, the company plans to present initial clinical results from the Phase 1 study, including results in hemophilia subjects, by the end of the year. These human study results are the first to be reported for Alnylam’s Enhanced Stabilization Chemistry-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency, durability, and a wide therapeutic index. Further, these initial clinical results demonstrate a greater than 50-fold potency improvement with ESC-GalNAc conjugates relative to standard template chemistry conjugates.
News For ALNY From The Last 14 Days
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September 18, 2014
07:49 EDTALNYAlnylam resumed with an Outperform at Leerink
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September 16, 2014
08:02 EDTALNYAlnylam presents ALN-CC5 pre-clinical data
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September 15, 2014
08:01 EDTALNYAlnylam names Karen Anderson as SVP, Chief Human Resources Officer
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07:21 EDTALNYHeart Failure Society of America to hold annual meeting
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September 12, 2014
08:02 EDTALNYAlnylam broadens pipeline with ALN-AGT
Alnylam Pharmaceuticals announced that it is broadening its pipeline with ALN-AGT. In a poster presented at the American Heart Association’s High Blood Pressure Research 2014 Scientific Sessions, Alnylam and collaborators at the Charite Universitatsmedizin in Berlin presented results of an ALN-AGT lead molecule in an established preeclamptic rodent model. The study showed that administration of ALN-AGT resulted in knockdown of maternal AGT in the liver without detectable evidence of fetal drug exposure, significantly improved pregnancy-related hypertension, ameliorated preeclamptic sequelae in the mother such as proteinuria, and improved fetal outcomes.

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