SAN FRANCISCO, Dec. 6 /PRNewswire-FirstCall/ -- Osteologix Inc. announced today that it has initiated a randomized, double-blind, placebo-controlled phase II clinical trial of NB S101, its investigational drug for osteoporosis. The primary endpoint of the study is the change in patients' bone resorption. Osteologix plans to enroll approximately 275 postmenopausal women with low bone mineral density and treat them for 12 weeks in the clinical trial, which is being conducted at investigator sites located throughout the UK and Denmark.
"I am very pleased to be initiating this phase II study within only three years of the creation of Osteologix and initiation of NB S101 development. Our goal is to build further evidence of the efficacy and safety of NB S101 as a primary treatment for osteoporosis," stated Charles J. Casamento, CEO and President. "There is a significant need for improved osteoporosis treatments. We believe NB S101 may have the ability to both increase bone formation and decrease bone resorption, while also reducing the side effects most common in osteoporosis drugs available today, providing a tremendous potential opportunity for Osteologix."
The clinical trial being initiated by Osteologix, "A dose-response study with strontium malonate in healthy post-menopausal women," is designed with five randomized arms. The company plans to enroll approximately 55 patients in each arm. Four arms of the trial will be double-blind, including three different doses of NB S101 (750 mg, 1000 mg and 2000 mg) and placebo. The primary endpoint will be the effect of NB S101 on CTX-1, a biochemical marker of bone resorption. NB S101 is the Osteologix investigational drug containing strontium malonate as its active ingredient. In addition to the four double- blind arms, there will be an open-label arm containing Protelos (strontium ranelate, approved in Europe for the treatment of Osteoporosis). The Protelos arm is open-label because Protelos is only available in a sachet and must be mixed with water prior to ingestion. NB S101 is a once-daily tablet available with increased bioavailability of free strontium when compared to Protelos (strontium ranelate).
In addition to the primary endpoint of quantifying bone resorption, Osteologix plans to evaluate the effect of NB S101 on bone formation by measuring markers specific for this process. Other secondary endpoints being evaluated include the effects of NB S101 on bone mineral density, strontium levels and markers of cartilage degradation. Side effects will also be assessed.
About Osteologix
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, has entered phase II clinical trials for the treatment of osteoporosis. Based on the Company's own data as well as data from phase III clinical trials conducted on another salt of strontium that is approved for sale in Europe, Osteologix believes that NB S101 increases new bone formation and decreases bone resorption. Osteologix further believes that NB S101 will provide patients with greater convenience and fewer side effects than drugs currently approved for osteoporosis in the United States, Europe and elsewhere, thereby addressing the need for an osteoporosis drug with higher compliance rates and better long term efficacy. The Company is not aware of any osteoporosis drug currently approved for sale in the United States that simultaneously increases bone formation and decreases bone resorption. Osteologix is committed to creating value by building a world- class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information on Osteologix can be obtained on the Company's website, www.osteologix.com.
FORWARD-LOOKING STATEMENTS:
Certain of the statements set forth in this press release constitute "Forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning," "expect," "believe," "will," "will likely," "should," "could," "would," "may" or words or expressions of similar meaning. All such forward looking statements involve risks and uncertainties, including, but not limited to: statements regarding Osteologix's research and development programs; proposed marketing and sales; patents and regulatory approvals; the effect of competition and proprietary rights of third parties; the need for and availability of additional financing and access to capital; and the seeking of joint development, licensing or distribution and collaboration and marketing arrangements with pharmaceutical companies. There can be no assurance that such forward-looking statements will prove to be accurate and Osteologix undertakes no obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements.
Osteologix Inc.CONTACT: Charles J. Casamento, Chief Executive Officer and President,+1-415-955-2726, or Matthew M. Loar, Chief Financial Officer,+1-415-955-2720, both of Osteologix Inc.
Web site: http://www.osteologix.com/
