OPKO Health (OPK) Submits IND for Rayaldee

August 7, 2014 3:49 PM EDT

OPKO Health, Inc. (NYSE: OPK), announced the submission of an Investigational New Drug (IND) Application to the United States (U.S.) Food and Drug Administration (FDA) under which Rayaldee™ will begin clinical evaluation as an adjunctive therapy for the prevention of skeletal-related events (SREs) in patients with bone metastases undergoing anti-resorptive therapy.

The initial investigation described in this IND is a phase 1 dose titration study designed to evaluate the safety and tolerability of Rayaldee in patients with breast or prostate cancer that has metastasized to bone who are receiving treatment with zoledronic acid (a bisphosphonate) or denosumab (a RANKL inhibitor). Approximately 24 subjects (12 with each cancer type) will receive Rayaldee at a starting daily dose of 30 µg (1 capsule) for 4 weeks. The dose will escalate in 30 µg increments at 4-week intervals until predetermined biochemical endpoints are reached, at which time the subjects will enter a 12-week maintenance phase. Safety parameters and various markers of bone metabolism, immune function and tumor burden will be monitored at regular intervals.

This study is expected to commence later this year and to take approximately 18 months to complete. Following evaluation of this initial study, OPKO plans to conduct subsequent studies investigating the effects of Rayaldee on SREs and other parameters deemed to indicate potential clinical benefits in the targeted population.



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