as an (asymptomatic) adverse event, the gastrointestinal adverse event profile was similar in incidence to that reported for other currently marketed phosphate binders. There was no increase in serum calcium noted in the study.
Dr. Julia Lewis, Professor of Medicine at Vanderbilt University, the Principal Investigator in the study, commented, "This study, as well as earlier studies, suggest that Zerenex is an effective, tolerated phosphate binder that will potentially make a significant clinical addition to treating the important universally present problem of hyperphosphatemia in patients with end-stage renal disease."
Ron Bentsur, Chief Executive Officer of Keryx, stated, "The promising safety and efficacy profile of Zerenex indicates that there is significant market potential for the drug in the phosphate binder space." Mr. Bentsur continued, "We're excited to have two late stage clinical drug candidates, Zerenex and KRX-0401 (perifosine), both with compelling Phase 2 data."
In the United States, according to data from the U.S. Renal Data System, there are approximately 485,000 patients with end-stage renal disease, or ESRD, and the number of ESRD patients is projected to rise 60% to approximately 785,000 by 2020. The majority of ESRD patients, over 350,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism (and its related cardiovascular complications), renal osteodystrophy and soft tissue mineralization. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. The need for alternative phosphate-binding agents has long been recognized, especially given the increasing prevalence of ESRD as well as shortcomings with current therapies. Zerenex has the potential to be an ef
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