BAGSVÆRD, DENMARK, June 11 / MARKET WIRE/ -- Novo Nordisk today announced the decision to discontinue the phase 3 clinical trial with NovoSeven® for the treatment of bleeding in patients with severe trauma. The decision was made based on the results of an analysis for futility conducted by the independent Data Monitoring Committee. The phase 3 trial was evaluating the efficacy and safety of NovoSeven® in severely injured trauma patients with bleeding refractory to standard treatment. The primary efficacy endpoint of the study was mortality and morbidity.
Due to an observed lower mortality than anticipated in the overall study group (around 10% in the phase 3 trial in total compared to more than 25% in the phase 2 trial), a futility analysis was conducted to assess the likelihood of reaching a successful outcome on the primary endpoint. The analysis predicted a low likelihood of obtaining a positive trial outcome with the planned study population, and as a consequence, Novo Nordisk has decided to discontinue the trial.
The decision is not due to safety concerns. In its latest review on safety data of 31 March 2008, the independent Data Monitoring Committee recommended continuation of the study.
Mads Krogsgaard Thomsen, executive vice president and chief science officer said: "It is regrettable that this trial is coming to an end. It has, however, already now provided a lot of important data on the treatment of severely injured patients. We will share these findings with the medical community as soon as the full clinical analysis has been completed."
The decision to discontinue the phase 3 clinical study with NovoSeven® for the treatment of bleeding in patients with severe trauma does not impact Novo Nordisk's expectations for the company's financial results for 2008, which were provided on 30 April in connection with the release of the financial results for the first quarter of 2008.
About the study
The study had enrolled more than 550 patients of the planned 1,502 in 24 countries. It was a multicentre, randomised, double-blind, parallel group, placebo-controlled trial to evaluate the efficacy and safety of NovoSeven® in severely injured trauma patients with bleeding refractory to standard treatment. Randomised patients received three single doses of NovoSeven® (200 mcg/kg + 100 mcg/kg + 100 mcg/kg) or placebo after the transfusion of the fourth unit of red blood cells)
The study has the primary endpoint of all cause 30-day mortality designed to show superiority of NovoSeven® compared to placebo in blunt trauma patients. If not superior, the endpoint included an analysis to demonstrate non-inferiority of NovoSeven® compared to placebo on all cause 30-day mortality and superiority of NovoSeven® compared to placebo on pulmonary and/or renal dysfunction requiring ongoing medical intervention at day 30 in blunt trauma patients. (ClinicalTrials.gov. Identifier: NCT00184548).
Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 26,300 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.
Stock Exchange Announcement no 34 / 2008
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