Bone Care To File For One-Alpha D2

Bone Care International has completed its two pivotal Phase III trialsof one-alpha D2, the lead product in its vitamin D analog pipeline, and says it now plans to file for approval for the product in February 1998. One-alpha D2 is indicated for the treatment of secondary hyperparathyroidism associated with end-stage renal disease.

Data from the trials were presented at the American Society of Nephrology meeting in San Antonio last week. The trials found that the abnormally high parathyroid hormone levels characteristic of the disease were reduced by more than 50% in 106 of 120 patients who completed at least 16 weeks' treatment with the oral drug. Reductions of more than 70% occurred in 97 patients.