| "Osteologix Inc. (OTC Bulletin Board: OLGX) announced today that it has completed enrollment in the "STRONG Study," its phase II clinical trial of NB S101, the company's investigational drug for osteoporosis. Osteologix has enrolled 289 postmenopausal women with low bone mineral density into the study, which is being conducted at nine sites located in the United Kingdom and Denmark. The primary endpoint in the trial is the change in patients' bone resorption, as measured by the biochemical marker CTX-1. Patients enrolled into the trial are being treated for 12 weeks. Osteologix expects to have results of the study near the end of 2007." " "Completing enrollment of all patients into our trial is an achievement which we are all very pleased to have accomplished," stated Stephan Christgau, Chief Operating Officer and leader of the osteoporosis drug development team at Osteologix. "The rapid pace at which we were able to recruit patients into the study indicates a tremendous interest in new and improved treatments for osteoporosis."" " Osteologix is developing NB S101, a once daily tablet containing strontium malonate as its active ingredient, as a treatment for osteoporosis. The phase II study evaluating NB S101 is a randomized, double-blind, placebo-controlled, parallel-group efficacy and safety trial with the objective of assessing the effects of NB S101 on bone metabolism while also evaluating its safety, tolerability and pharmacokinetics in postmenopausal women. There are five different treatment groups in the study -- three groups receive NB S101 (0.75 grams, 1.0 gram and 2.0 grams), one group receives placebo, and one group receives Protelos (a drug for osteoporosis approved in Europe) for a reference comparison. While the study is double-blind for the groups receiving NB S101 and placebo, the study is not blinded for the Protelos group because of its unusual dosing regimen. Protelos contains strontium ranelate as its active ingredient and is only available in a sachet formulation (a powder which must be mixed with water before ingestion). In addition to the primary endpoint of bone resorption, the company will evaluate the effects of NB S101 on bone formation and bone mineral density and will assess side effects." " Osteologix develops proprietary therapeutics for the treatment of important unmet medical needs in bone disease and women's health. The Company's lead product, NB S101, is being evaluated in a phase II clinical trial for the treatment of osteoporosis. Based on the Company's own data as well as data from phase III clinical trials conducted on a similar ... read the whole article |