Osteologix, Inc. (OLGX.OB), a specialty biopharmaceutical guests, announced that the U. S. Food and Drug Administration (FDA) have standard its Investigational New Drug (IND) submission in support of its front step alert entrant NB S101 (strontium malonate), for the inscription and rein of osteoporosis. NB S101, a twofold acting clean agent, has a demonstrated facility to decline resorption of bone while maintain conception of untried bone. The linctus has be formulate by method of a controllable once-daily tablet.
In September 2007, the company presented background from a Phase 1 den at the American Society for Bone and Mineral Research, demonstrating that NB S101 has person in costs bioavailability as compare to Protelos® (strontium ranelate), a strontium-based multiple accredited for rife people sale within Europe and other domain uncovered the United States.
In November 2007, Osteologix announced important grades from its Phase 2 STRONG Study, demonstrating that NB S101 meet its initial endpoint. At all dose tested, NB S101 demonstrated statistically significant decrease in CTX-1, a well-validated biomarker that measures bone resorption diversion. When head-on compared to the EU-approved strontium drug Protelos®, a 2 gram dose of NB S101 impose crucially greater reduction of CTX-1 (p<0.001) than the 2 gram dose of Protelos. In increment, all dose group demonstrated significant accumulate in bone limestone compression at 12 weeks.
When doripenem has been nearly untried investigationally via inhalation, pneumonitis has occur. DORIBAX should not be administered by this street.
Regarding the IND agreement, Osteologix President and Chief Executive Officer Philip Young said, "This be an earth-shattering footfall in the manoeuvre of sprouting this cool compound and we manifestation front to in use beside the agency as we make for the subsequent clinical trial." About Osteoporosis Osteoporosis is the zenith common bone bad robustness and, according to the National Osteoporosis Foundation (NOF), 10 million Americans be reasonably accurate to significant the disease and almost 34 million more are estimated to have osteopenia, or lint bone mass, introduction them at increased fluky for osteoporosis. The most meticulous impact of osteoporosis is skeletal fracture. Osteoporosis is in charge for greater than 1.5 million fracture annually and transmit expenditures for hip fractures are estimated to charge society more than $18 billion annually. According to NOF, one in two women and one in four man terminated age 50 can be anticipated to have an osteoporosis-related fracture at numerous extent.
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