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November 14, 2011
NPS Pharmaceuticals reported results from a phase III trial of NPSP-558 for the treatment of hypoparathyroidism. This double-blind, placebo-controlled trial, REPLACE, enrolled 135 subjects. Following randomization, subjects underwent staged reductions in calcium and vitamin D supplementation, while maintaining stabilized serum calcium. If needed, step-wise up-titration of NPSP558 or placebo to a dose of 75 g and, if necessary, up to 100 g over a six to eight week period was performed. Subjects continued on their final dose through week 24. The primary efficacy was to demonstrate by week 24 at least a 50 percent reduction from baseline of oral calcium supplementation and active vitamin D metabolite/analog therapy and a total serum calcium concentration that was normalized or maintained compared to baseline. In an intent-to-treat analysis, 53% of NPSP558-treated subjects achieved the primary endpoint versus 2% of placebo-treated subjects (p<0.0001). At week 24, 43% of subjects treated with NPSP558 were able to achieve independence from active vitamin D therapy and a calcium supplementation dose of 500 mg/day or less, as compared to 5% of subjects treated with placebo (p<0.0001).
March 23, 2009
OxiGENE reported positive results from a phase II trial of fosbretabulin for the treatment of anaplastic thyroid cancer (ATC). This US-based monotherapy trial enrolled 26 subjects with advanced or metastatic ATC who had progressed or relapsed following initial therapy. Fosbretabulin was administered on days 1, 8 and 15 of each 28-day cycle in a 10-minute intravenous infusion of 45 mg/m2. A total of 77 cycles of therapy were administered with a median of two cycles per subject. Treatment was continued until disease progression. Seven subjects (27%) experienced stable disease for at least six weeks, with a median duration of 12.3 months. The median survival was 4.7 months, with 34% of subjects alive at six months and 23% of patients alive at 12 months. Event-free survival at three months was 23.1% and at six months was 7.7%. Three subjects were alive at the time of last follow-up at 12.1, 24.4 and 37.9 months. Fosbretabulin was well-tolerated.