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Clinical Trials Update provides you with latest news about clinical trials conducted by MVA members. 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 news@mva.org.
Read about the latest clinical trials below or use the archive in the bottom of the page to gain insight into past trials.
Week 48
Lundbeck Expands its Pipeline - Initiating Phase II Clinical Trials with a New Compound for the Treatment of Schizophrenia
25 November - H. Lundbeck A/S expands its pipeline of pharmaceuticals in clinical development by initiating phase II trials with the compound Lu AE58054. The compound is a new pharmaceutical candidate in Lundbeck's portfolio and represents a novel approach to the treatment of schizophrenia.
Lu AE58054 has shown positive results in a number of preclinical trials, which documented the compound's ability to improve cognition. Lundbeck has now launched a phase II trial with two treatment groups of 60 patients each, and preliminary results are expected by the end of 2009.
Week 47
NeuroSearch Presents Remarkable Findings from the Company's Extensive Portfolio of Ion Channel Modulators in Neuropathic Pain
20 November - NeuroSearch have presented preclinical data from the company's drug discovery programmes in the field of GABA modulators and neuronal nicotinic receptor modulators (NNR modulators) for the treatment of neuropathic pain. The findings have been presented at the 38th Annual Meeting of the Society for NeuroScience (SfN), in Washington DC, United States.
Biovitrum and Symphogen Report Positive Clinical Results in Novel Rh-immunization Prevention Project
20 November - Biovitrum and Symphogen have completed the first part of a clinical proof of mechanism study of the recombinant human polyclonal antibody product Sym001 for future prevention of Hemolytic Disease of the Newborn (HDN) that can occur in RhD-negative mothers carrying a RhD-positive fetus. The preliminary results demonstrate that the recombinant human polyclonal antibody product is able to clear RhD-positive blood cells at five days after dosing in a dose dependent manner.
Phase III Studies Show That Vandetanib (ZACTIMA) Brings Clinical Benefits to Patients With Lung Cancer
19 November - AstraZeneca have announced results from three Phase III studies of ZACTIMA (vandetanib) in combination with chemotherapy agents docetaxel (ZODIAC) and pemetrexed (ZEAL) and as monotherapy (ZEST) in non-small cell lung cancer (NSCLC). Results from the ZODIAC and ZEAL studies showed advantages for vandetanib in combination with chemotherapy, compared to chemotherapy alone.
Week 46
Santaris Pharma Releases Positive Data on LNA-based Survivin Inhibitor
11 November - SPC3042 promotes death of cancer cells by blocking key cancer survival protein synergizes with paclitaxel in both in vitro and in vivo models of prostate cancer. The data has been published in Molecular Cancer Therapeutics.
Ofatumumab Pivotal Cll Data to be Presented at ASH
10 November - Genmab A/S announced that three ofatumumab abstracts have been accepted for presentation at the 50th American Society of Hematology Annual Meeting and Exposition 6-9 December 2008. Updated interim efficacy data from the pivotal study evaluating ofatumumab to treat two groups of chronic lymphocytic leukemia (CLL) patients with an unmet medical need will be presented in an oral session.
CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study
9 November - New data from the JUPITER study demonstrated that CRESTOR 20 mg significantly reduced major cardiovascular events by a dramatic 44% compared to placebo among men and women with elevated hsCRP but low to normal cholesterol levels. The JUPITER results were presented on 9 November at the American Heart Association Scientific Sessions and were simultaneously published online by the New England Journal of Medicine.
Week 45
Bavarian Nordic Reports Successful Safety Data from Phase II Study with IMVAMUNE
5 November - Bavarian Nordic has completed a clinical safety report from a large Phase II study with IMVAMUNE in HIV infected subjects that confirms the excellent safety profile of IMVAMUNE. Within the next few days the safety report of this study will be submitted to the FDA and this will trigger a USD 25 million milestone payment under the RFP-3 contract. The clinical safety report constitutes a major part of the data package that will be used to potentially support the use of IMVAMUNE in a declared emergency.
Advanced Encapsulated Cell Biodelivery Product for Alzheimer's Disease Successfully Implanted in Six Patients
3 November - NsGene A/S has announced that its encapsulated cell (EC) biodelivery product, NsG0202, has now been successfully implanted in a total of six patients with Alzheimer's disease (AD) at Karolinska University Hospital in Stockholm as part of an ongoing Phase Ib clinical trial.
>> October