Clinical Research

The Wellcome Trust is allocating £2.7 million to a UK project that will use new gene sequencing technology to identify mutations that predispose patients to cancer and then to integrate this information into routine patient care.

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AbbVie Inc (formerly part of Abbott Laboratories) is expanding its collaboration with Galápagos NV of Belgium to take the Galápagos JAK1 inhibitor, GLPG0634, into Crohn’s disease. The molecule is already being investigated for rheumatoid arthritis.

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Sanofi SA said that its JAK2 inhibitor for myelofibrosis met its primary endpoint in a Phase 3 pivotal study. The placebo-controlled study was conducted in 24 countries under a Special Protocol Assessment with the US Food and Drug Administration.

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Tocilizumab (Actemra/Roche) has been shown to be superior to adalimumab (Humira/Abbott) in a head-to-head Phase 4 study in patients with rheumatoid arthritis, according to an article in The Lancet on 4 May 2013. The article appeared earlier on-line.

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In another example of Big Pharma collaboration in the area of diabetes, Merck & Co Inc has announced plans to collaborate with Pfizer in the development and commercialisation of ertugliflozin, a Phase 3-ready diabetes drug in the SGLT2 class.

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MorphoSys AG has initiated a Phase 2 study of its proprietary antibody, MOR208, for patients with B-cell acute lymphoblastic leukaemia. The antibody is one of three in the clinic from the company’s internal portfolio. The study is taking place in the US.

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TiGenix NV has reported that a Phase 2a study of its allogeneic stem cell therapy in patients with refractory rheumatoid arthritis had positive six-month safety data. The trial enrolled patients who had failed to respond to at least two biologic therapies.

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A revolutionary T-cell immunotherapy developed by scientists at the University of Pennsylvania in the US has demonstrated a positive result in acute lymphoblastic leukaemia (ALL), an aggressive form of childhood cancer. The results of the treatment, which was administered to two patients aged seven and 10, are scheduled to appear in the 18 April 2013 edition of The New England Journal of Medicine. A summary of the study was released early on 25 March.

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CureVac GmbH has initiated a Phase 2b trial of its messenger RNA vaccine, a new treatment modality, in patients with castration-resistant prostate cancer. The trial will enrol up to 200 patients in eight European countries.

Merck Serono said that a Phase 3 trial of its integrin inhibitor, cilengitide, for the treatment of glioblastoma did not meet its primary endpoint of significantly increasing overall survival when added to the current standard of care, temozolomide and radiotherapy.

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