/Join_Us.gif)
/MVA_Sponsor_Top.gif)
/Danica_Pension.gif)
/Clinical_trial_470_x_80_(new).gif)
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 39
Data From One-Year Liraglutide Phase 3 Study Published in The Lancet
25 September - Data from a 52-week phase 3 study (LEADTM 3) of liraglutide, a once-daily human GLP-1 analogue, were published today by The Lancet. The study showed that liraglutide, when taken alone, produces statistically significant and sustained improvements in blood sugar control in patients with early type 2 diabetes, as compared with glimepiride, a widely used oral antidiabetic drug. Moreover, the treatment with liraglutide leads to weight loss, reduced systolic blood pressure and lower rates of hypoglycaemia after 52 weeks of treatment.
Week 38
Biovitrum begins Exinalda Study with Cystic Fibrosis Patients with Fat Malabsorption
16 September - Biovitrum AB has reported the start of a clinical phase II study with Exinalda, a candidate drug for the treatment of fat malabsorption. The aim of the study is to document the clinical effect of Exinalda in patients with pancreatic insufficiency as the result of cystic fibrosis. The study comprises 18 patients and is being conducted in Poland and the Netherlands. The results of the study are expected during the first half of 2009.
AstraZeneca and Targacept Announce Top-Line Results from Phase 2b Study of AZD3480 in Alzheimer's Disease
15 September - AstraZeneca and Targacept have announced that results from the Phase 2b clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in mild to moderate Alzheimer's disease were inconclusive.
In the 12-week placebo-controlled study, known as the Sirocco trial, neither the active comparator donepezil nor AZD3480 met the trial's criteria for statistical significance on the primary outcome measure, ADAS-Cog(1). Both results were impacted by an improvement in the placebo group.
Week 37
Levemir Demonstrates a 24-hour Duration of Action and Significant Weight Loss in Obese Patients
10 September - Data released at the European Association for the Study of Diabetes (EASD) Annual Meeting concludes that Levemir can lead to significant weight loss for insulin-naive patients with type 2 diabetes, and provides a similar blood glucose response as glargine with no significant difference in daily average consumption (DACON) or diabetes-related pharmacy costs.
New Data for Investigational Diabetes Drug Saxagliptin Demonstrates Potential for Type 2 Diabetes Treatment
9 September - Results from a 24-week Phase III study presented at the 44th European Association for the Study of Diabetes Annual Meeting demonstrated that saxagliptin, an investigational selective inhibitor with extended binding to the dipeptidyl peptidase-4 (DPP-4) enzyme, in development by Bristol-Myers Squibb Company and AstraZeneca, when used in combination with metformin as an initial therapy, produced reductions across all key measures of glucose control studied in treatment-naïve people with inadequately controlled type 2 diabetes, compared with monotherapy with saxagliptin or metformin.
Positive Belinostat Data in Cutaneous Lymphomas Presented at EORTCs Lymphoma Meeting in Copenhagen
8 September - TopoTarget have announces that positive data from a belinostat phase II study in patients with relapsing or resistant peripheral or cutanous lymphoma was presented at the "CUTANEOUS LYMPHOMAS : FROM THE MOLECULE TO THE CLINIC" in Copenhagen 5-7 September 2008.
Saxagliptin Improved Key Measures of Glucose Control When Added to a Sulphonylurea or Thiazolidinedione in People with Inadequately Controlled Type 2 Diabetes
8 September - Results from two 24-week Phase III studies presented at the 44th European Association for the Study of Diabetes Annual Meeting demonstrate that saxagliptin produced reductions across all key measures of glucose control studied when added to a sulphonylurea or a thiazolidinedione in people with inadequately controlled type 2 diabetes, compared with placebo added to either an increased dose of SU or a stable dose of a TZD.
New Data from a Phase 3 Study Confirms Clinical Benefits of Once-Daily Liraglutide in the Management of Type 2 Diabetes
8 September - Data from a phase 3 clinical study (LEAD 4) presented today at the 44th Annual Meeting of the European Association for the Study of Diabetes demonstrated that adding the investigational new drug liraglutide in the treatment of type 2 diabetes, leads to improved blood glucose lowering, weight loss, blood pressure reduction and improvement in beta cell functioning.
Positive Belinostat Data in Cutaneous Lymphomas Presented at EORTCs Lymphoma Meeting in Copenhagen
8 September - TopoTarget A/S (OMX: TOPO) announces that positive data from a belinostat phase II study in patients with relapsing or resistant peripheral or cutanous lymphoma (PTCL and CTCL) was presented at the "Cutaneous Lymphomas: From the Molecule to the Clinic" in Copenhagen 5-7 September 2008.
Week 36
Biogen Idec and ELAN Initiate First Clinical Trial of TYSABRI in Oncology
5 September - Biogen Idec and Elan Corporation have announced the initiation of the first clinical trial of TYSABRI (natalizumab) in oncology. The first dose of TYSABRI was administered yesterday in the trial. The objectives of this Phase I/II study are to evaluate the safety and potential anti-tumor activity of TYSABRI in patients with relapsed or refractory multiple myeloma. TYSABRI is a recombinant, humanized monoclonal antibody that targets the adhesion molecule VLA4 that is expressed on the surface of many types of immune cells.
/10_Good_reasons_to_Join_MVA!.gif)