Clinical Trial, BeNeLux

Prosensa Publishes DMD study results in NEJM

19.02.2008

Prosensa NV and researchers from Leiden University Medical Center (LUMC) under Prosensa's scientific advisor Prof. Gertjan van Ommen have published results from a Phase I clinical study with the 2-’O-methyl antisense compound PRO051 in four children (aged 10-13) with Duchenne Muscular Dystrophy (DMD) (N Engl J Med. 357(26):2677-86). Intramuscular injection of a single 80 mg shot of the compound, which is able to correct the open reading frame of the DMD gene by exon skipping and thus to restore dystrophin expression, was not associated with clinical adverse reactions, according to Prosensa. Additionally, PRO051 restored dystrophin expression in the treated muscle fibers of all four patients, who had been selected on the basis of their mutational status, muscle condition, and positive exon-skipping response to PRO051 in vitro. The compound will be suitable for 13% of all DMD patients (DMD incidence

1: 3,500), because it can treat a cluster of DMD mutations.

Miscellaneous, BeNeLux

16.05.2007

Brussels – UCB Group will initiate an additional short-term clinical study of CimziaTM (certolizumab pegol), its pegylated antibody directed against Tumour Necrosis Factor (TNF), to confirm the induction of clinical response in...

Miscellaneous, UK

16.05.2007

London – The European Medicines agency has recommended approval for Bristol-Myers Squibbs IgG1-CTLA4 binding protein Abatacept (Orencia) in combination with metho­trexate as a treatment for rheumatoid arthritis. The antibody...

Miscellaneous

16.05.2007

Looking at the performance of European biotech in 2007, it has turned out that both important US biotech indices, the Nasdaq Biotech index (+6.6%) and the AMEX Biotech index (+10.2%), outperformed our WestLB EU Biotech index...

Clinical Trial, France

16.05.2007

Nautilus Biotech (Evry, France) has initiated a Phase I clinical trial for subcutaneous Belerofon® (SC), its mutated human Interferon (IFN) alpha designed to have lower sensitivity to protease-mediated degradation than...

Clinical Trial, Switzerland

16.05.2007

A Novartis AG (Basel, Switzerland) has been given the green light from the US Food and Drug Administration (FDA) for its direct renin inhibitor Tekturna® (aliskiren) for the treatment of high blood pressure. The once-per-day...

Clinical Trial, Switzerland

16.05.2007

Roche AG (Basel, Switzerland) has been given market approval from the European Commission for its blockbuster VEGF inhibitor Avastin (bevacizumab) as a first-line treatment in combination with the chemotherapeutic paclitaxel for...

Clinical Trial, SwedenSweden

16.05.2007

Resistentia Pharmaceuticals AB (Uppsala, Sweden) has initiated a Phase II dose-escalation study of its anti-IgE immunotherapy, RP01, as a treatment for allergic asthma in mid-April. RP01 induced significant production of...

Editorial

16.03.2007

Germany currently holds the European Council presidency, which is why the German capital has been the site of choice for many European meetings and activities of late. In a recent Berlin meeting, Commission president José Manuel...

BioPeople

16.03.2007

Dr. Marc Cluzel (1) is the new Senior Vice President, Science and Medical Affairs at Sanofi-Aventis S.A. Cluzel joined the Montpellier-based Sanofi Recherche in 1991, gaining promotions until becoming Senior Vice President,...

BioPeople

16.03.2007

Dr. Koenraad Blot (2), will join Elbion NV´s management team as Chief Medical Officer and is returning to Belgium after many years of managing experiences abroad. Previously, Blot has worked as an Executive Director Clinical...

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