GTC Biotherapeutics (fka GTCB)

[DewDiligence]

NovoSeven for trauma: Here’s an old PR
from NVO that has some relevance to GTC.
There is a lot more information on this
subject from various sources.

http://www.noblood.org/news-hot-topics-such-hepatitis-c-sars-aids/1248-novoseven-r-study-shows-signi...

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New Study Shows Significant Reduction in Blood Transfusion Needed in Trauma Patients

December 19, 2003

BAGSVAERD, Denmark /PRNewswire-FirstCall/ -- Novo Nordisk A/S (NYSE: NVO ) today announced the first results from its phase 2 studies of the safety and efficacy of NovoSeven® in trauma patients. The study shows that patients receiving treatment with NovoSeven needed significantly less red blood cell transfusion than patients receiving conventional treatment.

Furthermore, results indicate that patients treated with NovoSeven had fewer complications and spent less time in intensive care units than patients receiving conventional treatment and, further, that overall mortality was lower in the group treated with NovoSeven. However, as the study was not designed to show differences in these parameters, these findings need to be investigated further in a subsequent study.

Equally important, in terms of safety, the study revealed no difference between the two treatment groups in the number or types of serious adverse events, including thrombo-embolic events.

Lars Rebien Sorensen, president and chief executive officer of Novo Nordisk, said, "The proof of concept for the use of NovoSeven is a major breakthrough in the treatment of patients with trauma and one of the most important events in Novo Nordisk's R&D pipeline in recent years."

The trauma study involved 280 patients in five continents, with critical bleeding related to either blunt or penetrating trauma. Patients that had been hospitalized with life-threatening bleeding, and who had already received transfusion of approximately 8 units of blood, were randomized to receive either NovoSeven or placebo, in addition to conventional treatment.

In the patients whose bleeding was caused by a blunt trauma, for example victims of traffic accidents, the effect of NovoSeven in reducing bleeding was statistically significant. In patients whose bleeding was caused by penetrating trauma, for example gunshots, there was a strong trend towards reduction of bleeding. In most countries blunt trauma is responsible for 75- 95% of the total number of traumatic injuries.

…ABOUT TRAUMA

Serious bleeding is the leading cause of death in traumatic injury related among others to traffic accidents, falls and use of weapons. Approximately 1.5 million people experience a major traumatic event per year in the Western world, and approximately 20% of those need blood transfusion.

In general traumatic injuries can be classified in one of two broad categories according to the injury, namely blunt and penetrating trauma. In the United States the distribution between the two major trauma categories is around 80% being blunt trauma and around 20% being penetrating trauma. Blunt trauma refers to injuries resulting from non-penetrating forces such as traffic accidents or falls. Penetrating injuries result from a piercing of the skin and damage to the deeper tissues or organs of the body. Penetrating injuries typically result from gunshot wounds or stabbing.

Usually a combination of surgical management, non-operative management and intravascular interventions is used in the treatment of trauma. Most patients with severe trauma experience acute hemorrhage. The significant reduction in intravascular blood volume resulting from severe trauma can lead to clinical shock and often cause death.

However, transfusions are associated with increased mortality and morbidity. Although blood transfusion is a crucial component in the management of trauma patients, recent studies have shown that infection and mortality rates in patients who receive blood transfusion are higher compared to those who do not. Reduction in blood loss, and a reduction in the level of blood transfusion, is therefore an increasingly important management objective.

ABOUT NOVOSEVEN®

NovoSeven is a recombinant hemostatic 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. Its unique mechanism of action induces hemostasis independently of FVIII and FIX. By stimulating a burst of thrombin production on the surface of activated platelets, rFVIIa is able to accelerate and strengthen the body's own clotting process. Factor Xa, in complex with other factors, then converts prothrombin to thrombin, which leads to the formation of a hemostatic plug by converting fibrinogen to fibrin and thereby inducing local hemostasis.
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