FDAnews
www.fdanews.com/articles/81248-osteologix-completes-phase-i-osteoporosis-trial

OSTEOLOGIX COMPLETES PHASE I OSTEOPOROSIS TRIAL

September 28, 2005

Osteologix has completed a Phase I clinical trial of its novel compound NBS-101 to treat osteoporosis. NBS-101 is a proprietary compound being studied as an improved tablet formulation of strontium, which was recently approved in Europe, in the form of strontium ranelate, and launched in several European countries.

The objective of this NBS-101 clinical trial was to establish the dose required to deliver the same blood levels of strontium as strontium ranelate, the recently approved European product. Preclinical studies had suggested that a substantially lower dose of NBS-101 may be bioequivalent to the 2 g dose used in the commercialized version currently available in European markets.

Using specific biomarkers for bone turnover, the study provided clinical evidence that NBS-101 had the dual effect of reducing degradation of bone while having a positive effect on bone formation. There were no treatment related side-effects in the study subjects who were given NBS-101.