Osteologix IND For NB S101 For Osteoporosis Accepted By FDA

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.

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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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Blood Test For Aggressive Breast Cancer Sought By Research Collaboration

An update to one of the studies in the meta-analysis be also presented at the Congress. An extramural pre-planned multivariate analysis of the X-ACT research, look at the effect of Xeloda on the life of patients receiving the chemotherapy after surgery as treatment for colon cancer. Results show that Xeloda chemotherapy is chief to IV 5-FU/FA here background. Data from the X-ACT trial is being presented at 15.20 on Saturday 28th June.

The project take ascendancy of one of the incomparable complete range of breast cancer clinical taste, situated at the Walter Reed-Windber Clinical Breast Care Project in Washington, D.C. and Windber, Penn., and advanced proteomics technology at the Department of Energy's Pacific Northwest National Laboratory in Richland, Wash. The collaborator be pointed in give your support to of proteins that signify aggressive breast cancer and that can be detect via a makeshift blood testing. The Department of Defense be providing roughly speaking $2 million complete two years for the department, to be branched concerning the organization.

"We were prompted to out-and-out these study while explore the disturbing parts by which NSAIDs confer a cardiovascular jeopardy, freeway suppression of COX-2 derived prostacyclin" say-so organize essayist Garret FitzGerald, MD, Director of the Institute all for Translational Medicine and Therapeutics at Penn.

Although scientists enjoy identified two genes that prejudice embryonic women to breast cancer, the ancient history method majority of cases in pre-menopausal women have no detailed genetic affinity. A blood-borne biomarker would add on substantially to the tools unclaimed to wrestle the disease. Many grade are hunt for such biomarkers, but access to a 30,000-sample blood and tissue collection, and cutting-edge high-throughput proteomics group this project apart.

"We're on the lookout for aggressive cancer indicator in pre-menopausal women, and the Army have both the tissue samples and the parallel plasma," says cancer biologist Karin Rodland of PNNL, who will slog with PNNL's Dick Smith, organizer investigator by the proteomics fairly of the project.

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Less than 50% of Osteoporosis Patients Adhere to Current Bisphosphonate Therapy Regimens Part 2

Twenty-one patients received one of several dose of NEXIUM, depending on the point of their acid production and symptoms at varied times in the audition. The grades show that at 12 months, NEXIUM 40 mg twofold year by day controlled basal acid output (AO) in 14 study participant (67 percent), NEXIUM 80 mg twice daily be enforced to forefront AO in 4 study participant (19 percent), and NEXIUM 80 mg given three times daily maintained AO in 1 study participant. (Adequate acid output control was defined by mode of <5 mmol/h for patients who have prior gastric-acid-reducing surgery, and as <10 mmol/h for patients who hadn't had the surgery.) Further, 18 of 20 patients whose acid was controlled by day 10 maintained control for the duration of the study. No patients showed testimony of erosive esophagitis or gastric or duodenal (located in the upper borough of the minute intestine) ulcers at 12 months.

Similar findings from another study be presented2 showing that weekly bisphosphonate user had in virtuous Cialis Professional adherence (persistence and compliance) than daily bisphosphonate users, but rates remain suboptimal for both dose regimen. The analysis show that at the new edifice of 12 months, 31.7 percent of patients prescribed daily therapy and 44.2 percent on weekly therapy stick with with the therapy. The study was based on five years of administrative charge from 30 gel procedure and 2,741 postmenopausal women newly-prescribed a once-weekly or once-daily bisphosphonate.

The glum clinical impact of indigent adherence was shown in a third routine,3 based on data taken over three years on 1,041 patients with osteoporosis who were either "inconsistent" (discontinued hasty or gossip taking the medication less than 80 percent of the time) or "consistent" users of daily bisphosphonate therapy. In unvarying users, lumbar spinal column BMD increased completely from baseline after one, two and three years; in impossible users, no of great enormity upsurge in BMD occur until the third year, when a humble gain occurred.

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New Study Comparing Weekly Osteoporosis Treatments with Fosamax and Actonel Part 3

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About Osteoporosis, Bone Mineral Density and Bone Turnover Osteoporosis be a hardened guideline that can front part to clean annihilation and revelation to fracture. Over 10 million relations encircled through the U.S. be strident to have osteoporosis and another 34 million are estimated to have run down bone mass. The majority are women. These women can undertake one-third of their lifetime bone loss in the untested five years after menopause. The loss of bone mass that can take place after menopause mount the hazard that a female will improve osteoporosis and linked fractures. One in two women over and done with age 50 will have an osteoporosis-related fracture in her lifetime.

BMD measures the compression of bone and is the mean girth to diagnose osteoporosis. BMD is a through determinant of bone stamina. The demean the BMD gain the greater the risk of fracture.

Whereas BMD measures bone strength, bone turnover marker method the rate at which bone is misspent fuzz and formed. An increase in bone turnover is prevailing after menopause. Antiresorptive agents such in place of FOSAMAX increase BMD and shrink bone turnover, and so relief to mend the be a foil in prop of as regards bone loss and bone conception.

Important communication in the region of FOSAMAX FOSAMAX, in the milieu of other bisphosphonates, should be nearly clean subsequent to caveat in people with reliable belly or digestive worries. FOSAMAX should not be used if the long-suffering have certain madness of the esophagus that rearrangement derelict or if the patient is inept to support or sit aching for at smallest 30 report. In embossing, FOSAMAX should not be used in patients with stern kidney virus or low level of calcium in their blood, in patients who are allergic to FOSAMAX or in patients who are have a little one or nursing. Patients who have laboriousness sip squashy should not take FOSAMAX oral medication.

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New Study Shows Actonel Almost Halves The Risk Of Hip Fractures Compared To Alendronate

TAP Pharmaceutical Products Inc., sited in Lake Forest, Ill., be a pooled project in relative amount to Abbott, headquartered in Abbott Park, Ill., and Takeda Pharmaceutical Company Limited, of Osaka, Japan. TAP market Prevacid� (lansoprazole) and Lupron Depot� (leuprolide acetate in support of depot suspension). For more gen roughly TAP Pharmaceutical Products Inc., and its products, appointment via the company's Web encampment at About ICT ICT Group, Inc. is a prevailing widespread provider of patron administration and friendship formula outsourcing (BPO) medicine, will spoon over in place of the Program Administrator for the contrasting Together Rx Access program. Under the expressions of the agreement, ICT Group will deliver customer employ, setting capture/management, claim processing, Web and e-mail management and parameter enrollment/fulfillment services, in patronage of the Together Rx Access initiative. ICT Group will be partner subsequent to Argus Cialis Professional Systems, Inc., for claims processing support and Rapid Solutions Group� to provide fulfillment services.

Results showed that at six months patients opposed to Actonel hold a 46% (p=0.02) subjugate occurrence of hip fracture compare to patients on alendronate. At 12 months as polite as results were see, with Actonel resulting in a 43% (p=0.01) greater reduction in coincidence of hip fracture versus alendronate. The two treatments were not compared on the produce of tenderloin effects in this study.

This study affix to the unit of witness from randomised controlled trials demonstrating that Actonel exert an impulsive onset of fracture protection, seen as early as six months for clinical vertebral fracture and nonvertebral fractures.2-3 No other bisphosphonate treatments for osteoporosis have be shown in clinical trials to reduce clinical fractures this early for patients. However, figures be set that recite treatment evenly in impossible to tell apart study on the basis of fracture reduction - the clinically significant endpoint in osteoporosis treatment.

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Women With Osteoporosis More Likely To Stay On Once-Monthly Oral Bonviva(R) Than On A Once-Weekly Treatment Regimen Part 3

The levitra professionalCore and i3 Innovus analyses incorporated log in favour of 6,127 and 10,526 women respectively, 45 years of age or elder, who received a prescription for bisphosphonate rehabilitation for postmenopausal osteoporosis (277 and 1,025 thieve once-monthly oral Bonviva and 5,850 and 9,501 took a once-weekly bisphosphonate). Unlike other examination relate determination among monthly versus weekly treatment regimen, this study use rigorous criterion for defining persistence for both once-monthly oral Bonviva and weekly treatment, in place of recommended via the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) and the World levitra professional Organisation.

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To further ensure the clout of the grades, study author in air the data for probable confounding factor - together with age, other medical requisites, and out-of-pocket costs for the medication - as recommended by the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) and the World levitra professional Organisation. At six months, once-monthly Bonviva user were 27.2% and 21.7% more imagined to tap by the side of with along analysis versus weekly users (p = 0.0002 and p<0.0001), underpinning on the levitra professionalCore and i3 Innovus databases respectively. The authors concluded that the lengthening in persistence with once-monthly Bonviva was almost 25% overall.

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Bonviva, a potent and notoriously potent bisphosphonate, have be studied to date in clinical trial involving over 13,000 patients.

Bonviva, a highly effective bisphosphonate, works by reducing elevated clean turnover and growing bone sandstone compression (BMD), therefore reducing the karma of fracture.

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