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BioMS Medical announces second quarter 2009 results

... trials evaluating dirucotide in patients with secondary progressive multiple sclerosis and with a ... trial of dirucotide for the treatment of secondary progressive MS (SPMS): - MAESTRO-01: ... in two pivotal phase III clinical trials for secondary Progressive MS patients, MAESTRO-01 in Canada and ...

Study on keeping nuclear bombs from US ports shows misplaced fear over cargo scanning cost

... of all containers, followed by a more careful secondary scan of only a few containers that fail the ... an additional $11-$13 for containers that require secondary inspection. This was, in part, due to the cost of ... train, and monitor private inspectors to analyze secondary inspection images; and to overcome some ...

BioMS Medical Announces First quarter 2009 results

... trials evaluating dirucotide in patients with secondary progressive multiple sclerosis, in the second ... with blockbuster potential for the treatment of secondary progressive multiple sclerosis." Currently, ... trial of dirucotide for the treatment of secondary progressive MS (SPMS): - MAESTRO-01: ...

BioMS Medical's pivotal international multiple sclerosis trial receives positive review from Data Safety Monitoring Board

... trial of dirucotide in patients with secondary progressive MS has completed a safety analysis ... and efficacy of dirucotide in patients with secondary progressive MS. The study is being conducted at ... in two pivotal phase III clinical trials for secondary Progressive MS patients, MAESTRO-01 in Canada and ...

BioMS Medical Announces 2008 Year End Results

... progression of MS, specifically in patients with secondary progressive multiple sclerosis." Currently, ... trial of dirucotide for the treatment of secondary progressive MS (SPMS): - ... annualized relapse rate or associated secondary magnetic resonance imaging (MRI) endpoints. ...

Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia

... 'Trial Meets Primary and Key secondary Endpoints' NEW YORK, March 10 /PRNewswire/ ... (PSG), meeting the prespecified primary and key secondary endpoints of the trial. ITI-007 also increased ... these results, meeting the primary and key secondary endpoints of the trial, and extended the findings ...

InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF

... - CAPACITY 2 Meets Primary and Key secondary Endpoints - - CAPACITY 1 Misses Primary ... in CAPACITY 2 (p=0.001), along with the secondary endpoints of categorical change in FVC and ... treatment effect on the primary endpoint and key secondary endpoints. Although the effect of pirfenidone did ...

BioMS Medical reports results of exploratory phase II trial of dirucotide in relapsing remitting multiple sclerosis

... development program for dirucotide is for secondary progressive MS where it is being evaluated in two ... endpoint, annualized relapse rate or associated secondary MRI endpoints. Dirucotide did meet certain secondary endpoints related to the progression of the ...

Epilepsia Study Demonstrates New Add-on Antiepileptic Drug Vimpat(R) (lacosamide) Significantly Reduces Partial-Onset Seizures in Adults With Epilepsy

... baseline to the maintenance period. secondary Endpoints Seizure freedom: ... of partial-onset seizures with or without secondary generalization in adult patients with epilepsy. ... partial-onset seizures, with or without secondary generalizations, for at least two years despite ...

TorreyPines Therapeutics Reports Third Quarter 2008 Results and Recent Accomplishments

... cross-over design in patients with xerostomia secondary to Sjogren's syndrome. The focus of an October 7, ... for NGX267 as a treatment for xerostomia secondary to Sjogren's syndrome, the anticipated timing ... the study of NGX267 as a treatment for xerostomia secondary to Sjogren's syndrome, and the ability to partner ...

TorreyPines Therapeutics Reports Successful End-of-Phase II Meeting With FDA for Tezampanel

... of NGX267, our muscarinic agonist, in xerostomia secondary to Sjogren's syndrome." About Tezampanel and ... for NGX267 as a treatment for xerostomia secondary to Sjogren's syndrome, the anticipated timing ... the study of NGX267 as a treatment for xerostomia secondary to Sjogren's syndrome, and the ability to partner ...

TorreyPines Therapeutics Strategically Repositions as Development Company Focusing on Three Versatile Lead Compounds

... II trial of NGX267 in xerostomia, or dry mouth, secondary to Sjogren's syndrome. The company has ... for NGX267 as a treatment for xerostomia secondary to Sjogren's syndrome, the anticipated timing ... the study of NGX267 as a treatment for xerostomia secondary to Sjogren's syndrome, the anticipated timing of ...

BioMS Medical's lead drug, dirucotide (MBP8298) for the treatment of multiple sclerosis, receives fast track designation from FDA

... drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is ... to become a first-in-class treatment for secondary progressive MS patients, a large patient ... - MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and ...

BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis

... study of dirucotide (MBP8298) in patients with secondary progressive MS. The interim analysis included ... - MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and ... efficacy of dirucotide (MBP8298) in patients with secondary progressive MS. The study is being conducted at ...

BioMS Medical completes patient recruitment in phase III U.S. multiple sclerosis trial

... 1. MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and ... percent of all MS patients have the secondary progressive form of the disease. About BioMS ... in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and ...

Cytochroma and Mitsubishi Tanabe form partnership for chronic kidney disease therapies in U.S. and Asia

... validation of our novel approach to treating secondary hyperparathyroidism in CKD patients." MTPC's ... obesity epidemic in countries worldwide. About secondary Hyperparathyroidism secondary hyperparathyroidism ("SHPT") is a condition ...

Oncolytics Biotech Inc. Announces 2008 Second Quarter Results

... in combination with paclitaxel and carboplatin. secondary objectives include the evaluation of immune ... describe any evidence of antitumour activity. The secondary objective is to determine the safety ... describe any evidence of antitumour activity. The secondary objective is to determine the safety and ...

TorreyPines Therapeutics Reports Fourth Quarter and Full Year 2007 Financial Results and Highlights

... is currently in a Phase II trial for xerostomia secondary to Sjogren's syndrome." 2007 Highlights: -- ... treatment of muscle spasticity and rigidity secondary to spinal cord trauma during the second half of ... clinical trial in xerostomia, or dry mouth, secondary to Sjogren's syndrome in March 2008. ...

Lilly and BioMS Medical Announce Global Licensing and Development Agreement

... has shown potential in slowing the progression of secondary progressive MS, and thus may provide an effective ... -- MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and ... percent of all MS patients have the secondary progressive form of the disease. BioMS Medical ...

Oncolytics Biotech Inc. Announces 2007 Third Quarter Results

... to patients receiving radiation treatment. A secondary objective is to examine any evidence of ... when administered in combination with docetaxel. secondary objectives include the evaluation of immune ... to obtain successful immune modulation. secondary objectives include the safety profile of the ...

Report recommends off-site disposal of secondary waste

... (CMA) to use off-site facilities to dispose of secondary waste during regular chemical agent disposal ... is just not enough for treating high volumes of secondary wastes such as carbon, wood dunnage, or ... Research Center, Newark, N.J. "Destroying the secondary waste concurrently at off-site locations whenever ...

Report recommends off-site disposal of secondary waste

... (CMA) to use off-site facilities to dispose of secondary waste during regular chemical agent disposal ... is just not enough for treating high volumes of secondary wastes such as carbon, wood dunnage, or ... Research Center, Newark, N.J. "Destroying the secondary waste concurrently at off-site locations whenever ...

AutoImmune Inc. Reports 2009 Second Quarter Financial Results

... Status Scale (EDSS), during the two-year Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study. Eli Lilly and BioMS also announced that they ...

Ceregene Receives Additional Grant From Michael J. Fox Foundation to Expand Long-Term Testing of CERE-120 Patients

... announced, however, that CERE-120 suggested improvement on several secondary endpoints at 12 months, and at 18 months, a statistically significant treatment effect on the primary endpoint emerged, while several additional secondary endpoints also showed improvement. In contrast, on no measure did sham ...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

... 0.1177), orBec(R) did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 ... failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value = 0.005) in the previous Phase 3 study as a key measure ...

AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

... multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. ... lines of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. ...

Spectrum Announces Fetal Bovine Serum Product Line

... US, Mexico, Canada, and Australia. In addition to untreated premium FBS, secondary treatments such as heat inactivation, dialysis, or gamma irradiation are ... (FDA) regulations. In addition to untreated premium FBS, secondary treatments such as heat inactivation, dialysis, or gamma irradiation are ...

Pharmaxis to Voluntarily De-List from Nasdaq

... of the demand from existing and potential international investors for the secondary listing of its American Depositary Shares ("ADS's") on Nasdaq and the volume of Pharmaxis ADS trading in the secondary Nasdaq market. The review concluded that the benefits of the Nasdaq ...

BioSyntech Reports Positive Results from Pivotal Trial for BST-CarGel(R) Cartilage Repair Device

... resonance imaging (MRI), and is still ongoing for the Interim Analysis. secondary endpoints of safety and knee-related pain, stiffness and function as ... tissue as measured with quantitative magnetic resonance imaging (MRI). secondary endpoints are safety and knee-related pain, stiffness and function as ...

InterMune Reports First Quarter 2009 Financial Results and Business Highlights

... was met with statistical significance in CAPACITY 2 (p=0.001), as were the secondary endpoints of categorical change in FVC (p=0.001) and Progression-Free ... there was evidence of a pirfenidone treatment effect on the pre-specified secondary endpoint of Six-Minute Walk Test distance (p=0.001) when compared to ...

Ocera Therapeutics Presents Data on AST-120 in Patients With Hepatic Encephalopathy at the European Association for the Study of Liver Disease Annual Meeting

... measures. A statistically significant reduction in pruritus, a secondary endpoint of the trial, was seen with AST-120 compared to lactulose. ... They include ammonia, indoles (serotonin, octopamine), histamine, secondary bile acids, advanced glycation endproducts (AGE), and certain bacterial ...

BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board

... U.S. pivotal phase III MAESTRO-03 trial of dirucotide in patients with secondary progressive MS has completed a safety analysis and recommended that the ... and is being evaluated in two pivotal phase III clinical trials for secondary Progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in ...

Frost & Sullivan Recognizes ApaTech's Leadership in Orthopedic Biologics

... for increasing biological activity, have the added advantage of avoiding a secondary procedure, and considerably eliminating the risks involved with surgery. ... measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry. About ...

Sirion Therapeutics Supplemental New Drug Application for Durezol(TM) to Treat Uveitis is Accepted for Review by the FDA

... structures. Prolonged use of corticosteroids may increase the hazard of secondary ocular bacterial infections, exacerbate the severity of ocular viral ... visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation ...

FDA Approves SyntheMed's REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery

... the risks to which their pediatric patients are routinely exposed during secondary open-heart surgical procedures. We are engaged in discussions with FDA ... presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical ...

InterMune Reports Fourth Quarter and Full Year 2008 Financial Results and Business Highlights

... statistical significance in CAPACITY 2 (p=0.001), as were the secondary endpoints of categorical change in FVC (p=0.001) and ... evidence of a pirfenidone treatment effect on the pre-specified secondary endpoint of Six-Minute Walk Test distance (p = 0.001) when ...

Results From Phase 2 Clinical Study of 6R-BH4 in Peripheral Arterial Disease Not Statistically Significant

... did not show a significant difference between 6R-BH4 and placebo, and the secondary endpoint, claudication onset time, also did not show a difference. ... evaluate mean change in peak walking time from baseline to week 24. The secondary objective of the study was to evaluate the mean change in claudication ...

Orexigen(R) Therapeutics Announces First of Four Phase 3 Trials of Contrave(R) Meets Co-Primary and Key Secondary Endpoints

... sustained release (SR)/bupropion SR) met its co-primary and key secondary endpoints, showing a significant reduction in body weight, improvements in ... All of these results remained highly statistically significant. secondary endpoints that demonstrated clinically and statistically significant ...

Kidneys for Transplant Function Earlier and Last Longer When Preserved in a Machine Compared to the Traditional Box of Ice

... and survival of the transplanted kidney may be inferior.(2) secondary endpoints included: patient and graft survival up to 12 months after ... There were no significant differences observed for the other secondary endpoints. No serious adverse events were directly attributable to ...

Video: Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse(TM) -- First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes

... or = 1-grade improvement on a 4-point Global Eyelash Assessment Scale. secondary efficacy endpoints were eyelash length, thickness, and darkness as ... strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has ...
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