Stephan Christgau, Ph.D., Principal Scientist with Osteologix’s Clinical Development Team and co-discoverer of the CTX-1 bone resorption marker highlighted the key data in this study:
• A single 1 gram dose of NB S101 was as effective as 2 grams of Protelos® (strontium ranelate) in increasing strontium to levels proven to prevent fracture
• The proprietary formulation of NB S101(strontium malonate), provides greater bioavailability than the comparator strontium formulation of strontium ranelate
• Bone resorption assessed with the CTX-1 marker indicated an acute dose dependent effect of NB S101 to reduce bone resorption
“Based on these Phase I data, we are extremely confident that NB S101 will meet its primary endpoints in the Phase II STRONG Study,” commented Malene Weis, M.Sc.Pharm., Director of Clinical Development at Osteologix. “We believe that the positive effect NB S101 exerts on bone turnover will be a welcome contribution to the osteoporosis treatment paradigm. We look forward to presenting our Phase II data to the scientific community in the fourth quarter of 2007.”
Philip J. Young, President and CEO of Osteologix added, “Importantly, the previously approved strontium formulation has been extremely well received by the patient and physician community in Europe. According to independent market analysis, strontium ranelate sales are expected to exceed $200 million in 2007. Should NB S101 continue to show positive results it will be well poised to capture a significant world wide market share when approved for commercial sale”.
The NB S101 Program and the STRONG Study
Osteologix has conducted extensive preclinical and clinical drug research with its proprietary DABA, NB S101. The Phase II STRONG Study evaluating NB S101 is a randomized, double-blind, placebo-controlled, parallel-group dose response study in 289 postmenopausal women. The results will provide data on the effects of NB S101 on bone metabolism, bone mineral density, safety, tolerability and pharmacokinetics. The primary endpoint in the trial is the change in patients' bone resorption, as measured by the biochemical marker CTX-1. Data from this trial will be reported in the fourth quarter of 2007.
About NB S101
NB S101 is a novel dual acting bone agent, or DABA, the active component of which significantly improves bone density and reduces fracture risk. In preclinical studies, NB S101 has demonstrated significant beneficial effects by reducing bone resorption and increasing high quality strong bone formation and bone mineralization. This dual action on bone– a significant medical need– suggests that NB S101 could fundamentally change the treatment paradigm of patients with osteoporosis. Importantly, NB S101 helps to build bone in a manner similar to the body’s own metabolic processes by rebalancing bone metabolism in a way that favors strong bone development. Osteologix has a competitive intellectual property position. A key patent for NB S101 has been issued in EU providing protection out to 2024, with US patents published and currently pending.
About Osteoporosis
Osteoporosis is the most common bone disease in humans and, according to the National Osteoporosis Foundation (NOF), 10 million Americans are estimated to have the disease and almost 34 million more are estimated to have osteopenia or low bone mass, placing them at increased risk for osteoporosis. The most severe consequence of osteoporosis is skeletal fracture. Osteoporosis is responsible for more than 1.5 million fractures annually and direct expenditures for hip fractures are estimated to cost society more than $18 billion annually. According to NOF, one in two women and one in four men over age 50 can be expected to have an osteoporosis-related fracture at some time.
About Osteologix
Osteologix is a specialty pharmaceutical company committed to developing innovative therapies for the treatment and prevention of musculoskeletal diseases. The Company’s vision is to improve the health of those afflicted with musculoskeletal diseases such as osteoporosis. Its lead product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit www.osteologix.com.