Extension in Medical Technology

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

... biopsies. An analysis of the Phase 2 and Phase 2 extension study biopsies using the improved methodology ... continue to receive treatment in an ongoing extension study designed to evaluate the long-term safety ... years. Results from the Phase 2 and the extension study were presented in March 2009 at the ...

Data Demonstrated ACTEMRA(R) (tocilizumab) Significantly Inhibited Progression of Structural Joint Damage in Rheumatoid Arthritis Patients

... analysis from two ongoing, long-term ACTEMRA extension studies consisting of patients who had completed ... serious infections. About the Long-Term extension Studies The interim analysis was from two ongoing, open-label, long-term extension studies consisting of patients who had completed ...

Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride: Oral 162

... advance for these patients." The LEAD(TM) 3 extension study also documented that treatment with ... the glimepiride group. About LEAD (TM) 3 extension The LEAD(TM) 3 extension compared the efficacy and safety of liraglutide ...

New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease

... given the option of continuing in a blinded study extension through 54 weeks. The proportion of patients ... including individuals who did not enter the study extension and were assumed to be non-responders to therapy ... of only those individuals participating in the extension (N=280), 72 percent of patients receiving ...

Savient Provides Update on Pegloticase BLA

... adjudication of the Company's Open Label extension study employing the same criteria used for the ... were no patients on placebo during the Open Label extension study. The panel found 2 APTC cardiovascular ... mortality in the Phase 3 trials and Open Label extension study. It is important to note that in the Phase ...

Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

... to subsequently enroll into the Nplate long term extension study which demonstrated that Nplate continued to ... platelet counts. In this open label long term extension study the average treatment period was 76 weeks ... was 204 weeks. Key findings from the extension study showed platelet counts of Nplate-treated ...

Amicus Therapeutics Announces Positive Progress of Three Lead Clinical Programs and General Outlook for 2009

... 2 studies continue to be treated in a voluntary extension study to characterize the long-term safety and ... doses and dose regimens. Data from this extension study are expected to be available in the first ... an 11 week treatment period with an optional extension study. The objectives of the trial include the ...

Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback

... (FDA) recently indicated that the ongoing extension of the DURATION-1 study is appropriate to use as ... data is dependent upon DURATION-1 study extension results that are expected in early 2009. ... intended clinical endpoints; the DURATION-1 study extension results potentially not being accepted to support ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... updated results from the ongoing, open-label extension study of the long-term safety and efficacy of ... weeks. Additional key findings from the extension study show: -- Platelet counts increased: ... in the controlled clinical studies. In the extension study, one patient with ITP and hemolytic anemia ...

CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years

... Scientific Meeting. Results from the open-label extension study to RAPID 1 met both co-primary endpoints ... baseline in mTSS(b) at week 52. An open-label extension study continued to evaluate the effects of CIMZIA ... to RAPID 1 (028) The Phase III, open-label extension (OLE) study to RAPID 1 is investigating the ...

Diverse Approaches to Alzheimer's Therapies Continue to Show Progress at ICAD

... Eighteen-month data from an open-label extension of a pivotal trial of Dimebon (Medivation) in ... approach." 18-Month Data from an extension of a Pivotal Trial of Dimebon in Alzheimer's In ... at UCLA, and colleagues reported on an open-label extension of the trial to 18 months. One hundred ...

Medivation Presents Positive New Data on Dimebon's Long-Term Efficacy and Novel Mechanism of Action at the International Conference on Alzheimer's Disease

... Alzheimer's Patients for 18 Months in Open-Label extension of First Pivotal Trial New data from a six-month open-label extension of the 12-month placebo-controlled study of ... the 18-month treatment period. The open-label extension data were presented in a poster session ...

NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety Extension

... results from the 52-week open label safety extension that was conducted following the completion ... and symptoms of osteoarthritis. The 301 safety extension study was conducted in 92 clinical centers in the ... arm. Design and top-line results of the 301 extension study The patient population characteristics in ...

New England Journal of Medicine Publishes Results From a RELISTOR Phase 3 Clinical Study

... to enter a subsequent three-month, open-label extension study. Patients in the extension study received RELISTOR as needed, not more ... response rates remained consistent throughout the extension study. Overall safety data from the studies ...

Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission

... -- Results from an open-label extension study of two Abbott pivotal studies, CHARM and ... into a non-placebo controlled, ongoing open-label extension (OLE) trial. Patients from CHARM were followed a ... followed a total of one year. The CHARM extension data demonstrated that three out of four ...

Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annual Meeting

... bipolar mania studies with a nine-week extension and in two out of four short-term schizophrenia ... three-week trials followed by an extension study totaling one year of treatment involving ... between asenapine and olanzapine). In a 9-week extension of the 3-week trials, asenapine was found to ...

FTY720, a novel oral therapy in development for MS, shows sustained benefits for the majority of patients after three years of treatment

... - Phase II study extension shows 68-73% of patients with multiple sclerosis ... 5 mg once-daily. This was followed by a long-term extension in which all patients took FTY720. At the end of ... screening of patients was implemented in the extension after a small number of cases of localized skin ...

NPS Reports Successful GATTEX(TM) Extension Study

... are dependent upon parenteral nutrition (PN). The extension study enrolled 65 of the 71 patients (91%) who ... placebo. The primary objective of the Phase 3 extension study was to evaluate the long-term safety and ... up to 52 weeks (24-week Phase 3 study and 28-week extension study). Overall, both doses of GATTEX were safe ...

Post-Hoc Data Show Daily Activity Participation, Independence and Sleep Quality Improved in Adults with Moderate to Severe Rheumatoid Arthritis After Treatment with ORENCIA(R) (Abatacept)

... followed by an ongoing, open-label, long-term extension study. A total of 376 (from the original 424) ... discretion of the investigator in the long- term extension study. Primary reasons for discontinuation in the long-term extension studies were adverse events, withdrawal of ...

Five-Year Data Demonstrate Long-Term Efficacy and Safety with ORENCIA(R) (abatacept) in Adults with Rheumatoid Arthritis Who had an Inadequate Response to Methotrexate

... five-year data from an open-label long-term extension of a Phase IIb trial demonstrate the long-term ... double-blind period, 219 entered the long-term extension (ORENCIA 10 mg/kg=84; ORENCIA 2 mg/kg=68; ... years. Baseline RA characteristics for long-term extension patients were similar between groups at initial ...

Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Legs Syndrome

... two Phase III pivotal trials and one open-label extension trial of rotigotine transdermal system for the ... interim analysis of a long-term, open- label extension of rotigotine for moderate-to-severe RLS, ... and somnolence (12.6%) 24-Month, Open-Label extension Trial in RLS SP 710 * In an ...

July 2009 Mayo Clinic Women's HealthSource Highlights Food Storage Safety, Energy Therapies and Vitamins and Minerals

... or call toll-free for subscription information, 1-800-876-8633, extension 9751. Foods may look, smell and even taste fine -- and still ... medical research at Mayo Clinic. To subscribe, please call 1-800-876-8633, extension 9751, (toll-free) or visit www.bookstore.mayoclinic.com . ...

July 2009 Mayo Clinic Health Letter Highlights a Positive Outlook, Bell's Palsy and Heart Valve Repair

... or call toll-free for subscription information, 800-333-9037, extension 9771. An ever-expanding body of research indicates that a ... and medical news. To subscribe, please call 800-333-9037 (toll-free), extension 9771, or visit www.HealthLetter.MayoClinic.com . ...

June 2009 Mayo Clinic Women's HealthSource Highlights Summer Skin Problems, Low Vision and Pilates

... or call toll-free for subscription information, 1-800-876-8633, extension 9751. Tips to Prevent (or Soothe) Summer Skin Problems ... medical research at Mayo Clinic. To subscribe, please call 1-800-876-8633, extension 9751, (toll-free) or visit www.bookstore.mayoclinic.com . ...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

... seizure frequency over the long-term(1). Results from the one-year extension of a pivotal Eslicarbazepine Acetate phase III study were presented at the ... (HRQoL) as measured by the QOLIE-31 score during a one year open label extension of the above 3 studies. ESL is given orally once-daily. ESL can be used as ...

Study Demonstrates Efficacy of Pitavastatin in Elderly Patients

... 80 percent were taking concomitant medications. A 60-week, open-label extension to this core study was conducted to assess the long-term safety of ... safety profile to low-dose pravastatin. In addition, results from the extension study showed maintenance of the efficacy and safety of pitavastatin 2 mg ...

Proteolix Presents Positive Clinical Data for Carfilzomib in Multiple Myeloma at the 2009 ASCO Annual Meeting

... Ten percent of patients completed twelve cycles of treatment and an extension study has been initiated for patients who have stayed on drug for one ... percent have received 12 cycles of treatment and have been enrolled in an extension study. Adverse events were generally mild and manageable. These data ...

Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple Sclerosis

... includes: - The CLARITY (CLAdRIbine Tablets Treating MS OrallY) extension study: a two-year placebo-controlled extension of the CLARITY study, designed to provide data on the long-term safety and ...

March 2009 Mayo Clinic Health Letter Highlights Knee Repair Surgery, Anxiety Disorder and Preventing Blood Clots

... or call toll-free for subscription information, 800-333-9037, extension 9771. Active at 50? Still Prime for Knee Repair Surgery A torn ... and medical news. To subscribe, please call 800-333-9037 (toll-free), extension 9771, or visit www.HealthLetter.MayoClinic.com . ...

February 2009 Mayo Clinic Women's HealthSource Highlights Diabetes and Heart Disease, Going Vegetarian and Tinnitus

... or call toll-free for subscription information, 800-876-8633, extension 9751. What's the most common long-term complication of diabetes? ... medical research at Mayo Clinic. To subscribe, please call 800-876-8633, extension 9751, or visit www.bookstore.mayoclinic.com . ...

GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP

... Seven patients experienced thrombotic/thromboembolic complications in the extension study. Use caution when administering PROMACTA to patients with known risk ... received 50 mg PROMACTA daily and two placebo-group patients (3%). In the extension study, cataracts developed or worsened in 4% of patients who underwent ...

FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder

... Seven patients experienced thrombotic/thromboembolic complications in the extension study. Use caution when administering PROMACTA to patients with known risk ... received 50 mg PROMACTA daily and two placebo-group patients (3%). In the extension study, cataracts developed or worsened in 4% of patients who underwent ...

CIMZIA(R) (Certolizumab Pegol) Provides Long-Term Benefit Without Dose Escalation in Crohn's Disease Patients

... other commonly-used biologics. An analysis of the PRECiSE 3 open-label extension study data showed that after 2.5 years (30 months) of treatment with ... PRECiSE 3 Study (Abstract #P280) The PRECiSE 3 (P3) open-label extension study of PRECiSE 1 and PRECiSE 2 was designed to evaluate the longer-term ...

September 2008 Mayo Clinic Health Letter Highlights Cataract Removal, Severe Headache and Dual Energy X-Ray Imaging

... or call toll-free for subscription information, 800-333-9037, extension 9771. One aspect of aging that's usually fixable is cloudy vision due ... and medical news. To subscribe, please call 800-333-9037 (toll-free), extension 9771, or visit http://www.HealthLetter.MayoClinic.com . ...

August 2008 Mayo Clinic Women's HealthSource Highlights Avoiding Blood Pressure Increase at Menopause, Healthful Benefits of Dark Chocolate and Scheduling a Colorectal Exam

... or call toll-free for subscription information, 800-876-8633, extension 9751. Ways to Avoid Blood Pressure Increase at Menopause Five steps to ... medical research at Mayo Clinic. To subscribe, please call 800-876-8633, extension 9751, or visit http://www.bookstore.mayoclinic.com . ...

June 2008 Mayo Clinic Women's HealthSource Highlights Shingles Vaccine for Pain Prevention, Tips to Avoid Antibiotic Resistant Infections, and Benefits of Broad Genetic Testing

... or call toll-free for subscription information, 800-876-8633, extension 9PK1. Pain Prevention for Older Adults -- the Shingles Vaccine A ... medical research at Mayo Clinic. To subscribe, please call 800-876-8633, extension 9PK1, or visit http://www.bookstore.mayoclinic.com . ...

PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity

... of mean CFTR-dependent chloride secretion in the airways. The Phase 2a extension study in Israel assessed 3 months of oral PTC124 therapy at two different ... showing improvement in TEPD chloride secretion increased over time in the extension study. Trends towards improvements in mean FEV1 and FVC values were ...

Pharmaxis Long-Term Safety Study of Bronchitol Completes

... has completed. This 12-month treatment period was an open label extension to a three- month efficacy trial which has already reported, showing that ... quality of life and mucus clearance. The objective of the open label extension is to determine the adverse event profile of Bronchitol following ...

More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL

... WYE ), announced today that it is withdrawing its application for an extension to the European Marketing Authorization for TYGACIL(R) (tigecycline). This extension sought approval of TYGACIL for the treatment of community-acquired ...

Update From Mipomersen Extended Dosing Study Continues to Show That Mipomersen Is Well Tolerated and Maintains Activity in Patients Treated for Up to 16 Months

... ISIS ) announced additional results from its ongoing Phase 2 open-label extension (OLE) study of mipomersen in patients with familial hypercholesterolemia ... were retreated with mipomersen in the OLE study. "This open-label extension study suggests that mipomersen can be administered with a satisfactory ...