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Clinical Trials Update provides you with latest news about clinical trials conducted by MVA member companies. The update gives insight to progress in studies, results and possible indications. As an MVA member please feel free to send us press releases for Clinical Trials Update at akn@mva.org.
Week 43
Nycomed's Daxas Shows Encouraging Preliminary Results
28 October - Nycomed has announced encouraging results from a preliminary analysis of four Phase III trials of Daxas (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies met their primary endpoints, showing effects on exacerbation rates and pulmonary function (FEV1). Furthermore, two supporting six-month studies confirmed the efficacy of Daxas when used with standard bronchodilator treatments. Further analysis including the secondary endpoints is ongoing and full data from all four studies are expected to be published during 2009 and they expect to file for European and US marketing authorisation next year.
Active Biotech Presents New Data regarding the 57-57 SLE Project at American College of Rheumatology Meeting
28 October - Active Biotech has presented data regarding the 57-57 project at the American College of Rheumatology (ACR) Annual Scientific Meeting held in San Francisco on 24-29 October. In a completed Phase Ib trial twelve patients have been treated for 84 days at various dose levels of ABR-215757. The maximum tolerable dose (MTD) for ABR-215757 was defined as 4.5 mg/day. The overall safety profile throughout the study was very favorable.
Week 42
Study Results: Multiple Sclerosis Patients Have Significant and Sustained Reduction in Disability and Risk Of Relapse On Alemtuzumab Versus Approved Therapy, Rebif
October 22 - Genzyme Corporation and Bayer HealthCare Pharmaceuticals Inc. have announced study results showing that patients with early relapsing-remitting multiple sclerosis (RRMS) taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 74 percent and the risk of sustained accumulation of disability by 71 percent compared to patients treated with the active comparator Rebif® (high-dose interferon beta-1a). Importantly, the mean disability of patients on alemtuzumab improved from baseline, whereas the mean disability of those on Rebif worsened. The treatment benefits of alemtuzumab were sustained for at least three years, even though the majority of alemtuzumab-treated patients were last dosed two years earlier. These results come from the final three-year analysis of a Phase 2 clinical study (CAMMS223) reported in the Oct. 23 issue of the New England Journal of Medicine.
Positive BelCaP data in bladder cancer patients in Phase II study presented at the AACR/NCI/EORTC "Molecular Targets and Cancer Therapeutics" conference 2008
22 October - TopoTarget has presented promising data in bladder cancer using the BelCaP regimen with 1 complete response (CR), 3 partial responses (PR) and 10 patients out of 15 experiencing stable disease (SD). The data was presented at the AACR/NCI/EORTC "Molecular Targets and Cancer Therapeutics" conference 2008. BelCaP (belinostat in combination with standard doses of carboplatin and paclitaxel) was administered to patients with bladder cancer, who had previously relapsed from treatment with carboplatin/cisplatin.
New Data from Head-to-head Phase 3 Trial Demonstrate that Liraglutide is More Effective than Exenatide in Treatment of Type 2 Diabetes
17 October - At the Canadian Diabetes Association Congress, physicians will get a first-time look at more detailed results from a phase 3b clinical study (LEADTM 6) comparing the investigational new drug liraglutide to exenatide. The study showed that liraglutide, a human GLP-1 analogue administered once daily, was significantly more effective at improving glycaemic control (as measured by HbA1c) than exenatide, a GLP-1 mimetic administered twice daily.
Week 41
Biogen Idec Announces Top-Line Results from Phase II Clinical Trial of Baminercept in Rheumatoid Arthritis
9 October - Biogen Idec has announced that its Phase II trial of baminercept (BG9924, LT(beta)R-Ig) in rheumatoid arthritis (RA) patients who have had an inadequate response to conventional therapy with a disease-modifying antirheumatic drug (DMARD) did not meet its primary endpoint. The primary endpoint was defined as the proportion of baminercept-treated patients who achieved an ACR50 response, a standard measure of disease improvement in RA, compared to placebo at 14 weeks. The study also did not meet any of the pre-specified secondary endpoints. Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.
Ofatumumab Induces Long Lasting Clinical Responses in Phase II RA Study
8 October - Genmab have announced that data showing that rheumatoid arthritis patients who participated in the ofatumumab (HuMax-CD20®) Phase II study achieved long lasting results at the 48 week follow up period. The data will be presented in a poster session at the ACR/ARHP 2008 Annual Scientific Meeting in San Francisco, California on October 26, 2008.
Bavarian Nordic Announces Positive Mature Phase II Results from Newly Acquired Prostate Cancer Vaccine
7 October - 125 patient, prospective randomized placebo-controlled phase II study shows statistically significant improved overall survival. Bavarian Nordic has now evaluated the mature phase II data from the therapeutic prostate cancer vaccine candidate PROSTVACTM that had been obtained as part of the recently entered partnership with the National Cancer Institute (NCI) in the US. The results from the Phase II prospective randomized placebo-controlled study of 125 patients with advanced prostate cancer after 4 years of follow-up show that patients receiving PROSTVACTM had a statistically significantly longer median overall survival by 8.5 months (p=0.015) compared to the control group.
Phase III Study Showed Rituxan in Combination with Chemotherapy Improved Progression-Free Survival in Patients with Relapsed Chronic Lymphocytic Leukemia
6 October - Biogen Idec along with Genentech have announced that a global Phase III study of Rituxan® (rituximab) in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival, as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study. An independent review of the primary endpoint is being conducted for U.S. regulatory purposes.
