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Biotech / Medical : MAXY - Maxygen, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (212)	2/26/2007 6:10:10 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 262

Phase 3 stroke trial shows that NovoSeven® reduces bleeding in the brain, but does not improve long-term clinical outcomes (26 Feb 2007) Novo Nordisk today announced the initial results of a phase 3 clinical trial investigating NovoSeven® (recombinant activated factor VII) for the treatment of people suffering from bleeding in the brain, also known as intracerebral haemorrhage, or ICH. The trial showed that treatment with NovoSeven® significantly reduced intracerebral bleeding compared to placebo treatment. Improvement in clinical outcomes in terms of functional independence and neurological impairment was observed on day 15 after the bleeding, but mortality and severe disability was not improved at the end of the study period (day 90). With regard to safety, study results were in line with the established safety profile of NovoSeven®. As mortality and severe disability at day 90 was the primary endpoint of the study, Novo Nordisk has decided not to seek regulatory approval for NovoSeven® in ICH. Novo Nordisk's other research and development activities within the management of critical bleedings will continue as planned. Lars Rebien Sørensen, president and chief executive officer of Novo Nordisk, said: "These results are disappointing, particularly given the encouraging results we saw in the phase 2 trial. We hoped that NovoSeven® could become a treatment for the people who suffer from ICH, and for whom no effective medical treatment exists." The phase 3 trial in ICH involved 821 patients from 22 countries in a multi-centre, randomised, double-blind, placebo-controlled efficacy and safety study. People suffering from spontaneous ICH confirmed by a CT (Computed Tomography) scan were randomised to receive either NovoSeven® or placebo within four hours of symptom onset, in addition to conventional treatment. Further details from the phase 3 trial results are expected to be communicated at the 59th Annual Meeting of the American Academy of Neurology held in Boston from 28 April to 5 May 2007, and at the European Stroke Congress in Glasgow from 29 May to 1 June 2007.