Novo Nordisk A/S announced the first results from the clinical trial conducted in the treatment of intracerebral hemorrhage (ICH). The phase IIb study demonstrated that treatment with NovoSeven of ICH patients led to a significant reduction in hematoma growth compared to the placebo group, according to a company release.

Importantly, results demonstrated that patients treated with NovoSeven had significantly improved neurological and functional outcome, implying a lasting patient benefit in terms of reduced disability and dependency on help. This is the first time such encouraging results have been observed in any ICH trial.

The study showed that treatment with NovoSeven for ICH was associated with a minor, non-significant increase in thromboembolic events that was vastly outweighed by highly significant clinical benefits across the trial.

Lars Rebien Sorensen, president and chief executive officer of Novo Nordisk, said, "The proof of concept for the use of NovoSeven in the treatment of intracerebral hemorrhage represents a pioneering breakthrough. It is a major step forward in our aspiration to develop NovoSeven as a general treatment of critical bleedings. This is an extraordinary extension of the positive results obtained in the treatment of trauma victims late last year."

The ICH study involved 400 patients in 20 countries, in a multi-centre, randomized, double blind, placebo-controlled dose-response study. Patients who all had spontaneous ICH confirmed by Computed Tomography (CT) scan within three hours of symptom onset, were randomized to receive either NovoSeven or placebo, in addition to conventional treatment.

Studies indicate that each year around 250,000 people in North America, Europe and Japan experience an Intracerebral Hemorrhage (ICH), also known as hemorrhagic stroke. ICH is the most deadly and least treatable form of stroke.

NovoSeven is a recombinant haemostatic agent (recombinant activated factor VII). The product is currently registered for treatment of bleeding episodes in hemophilia patients with congenital or acquired inhibitors against the clotting factors VIII or IX.

Based on the data, Novo Nordisk will immediately liaise with regulatory agencies in the effort to achieve approval for the use of NovoSeven as the first pharmaceutical treatment of ICH.