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March 20, 2013
19:17 EDTISISIsis Pharmaceuticals presents data from phase 1 study at AAN meeting
Isis Pharmaceuticals announced that data from the Phase 1 study of ISIS-SMNRx in children with spinal muscular atrophy were presented at the 65th American Academy of Neurology Annual Meeting by Dr. Claudia Chiriboga, from Columbia University Medical Center. In the presentation, Dr. Chiriboga reported that, in this single-dose, open-label study, ISIS-SMNRx was well tolerated in children with SMA at all dose levels tested and that improvements were observed in Hammersmith scores, a measure of muscle function, in a number of the children. "We are cautiously optimistic with the observed improvements in muscle function in the higher dose cohort, however, we will need further clinical data from a controlled study to assess the safety and activity of this drug in patients with SMA. We plan to have additional clinical data from our ongoing multiple-dose study in children with SMA by late 2013 or early 2014. We also plan to initiate a Phase 2/3 program in infants this year and a Phase 2/3 study in children in the first half of 2014," said Stanley T. Crooke, M.D., Ph.D., chairman of the board and chief executive officer at Isis.
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September 2, 2014
19:28 EDTISISIsis Pharmaceutical licensing partner Antisense reports ATL1103 phase II results
Antisense Therapeutics, or ANP, reported the primary efficacy results from its phase II clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. The phase II trial met its primary efficacy endpoint showing a statistically significant average reduction in the serum insulin-like growth factor-I, or sIGF-1, levels of 26% from baseline at week 14 at the 400mg per week dose tested. All patients treated with 400mg per week of ATL1103 had a reduction in sIGF-I levels from baseline at week 14. Greater reductions in sIGF-I were observed in patients who had lower body weights and thereby received a relatively higher dose per kg bodyweight with the patients who received 5.5 mg/kg per week showing a 36% average reduction in their sIGF-I levels. The positive results achieved in this Phase II trial position ATL1103 to move into Phase III stage of development. Consequently, ANP will accelerate out-licencing activities to secure a pharmaceutical development partner for the drug's further development. ANP has 4 products in its development pipeline that it has in-licensed from Isis Pharmaceuticals, including ATL1103.

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