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news.Catalyst Biosciences has selected CB 813, a second-generation variant of human coagulation factor VIIa, as a development candidate for the treatment of acute bleeding in hemophilia patients.
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CB 813 is designed to substantially enhance clot-generating activity at the site of bleeding and therefore achieve clinical efficacy with fewer and lower doses than current therapy.
In established hemophilia models of acute bleeding, CB 813 has demonstrated a significant improvement in potency compared with the marketed recombinant factor VIIa product, NovoSeven and a competing, second-generation product, NN1731. Catalyst intends to file an investigational new drug application for CB 813 and commence human clinical studies in hemophilia patients in 2009.
Nassim Usman, CEO of Catalyst, said: “Created to more rapidly and effectively stop bleeding, CB 813 holds great promise as a new agent in the treatment of hemophilia. CB 813 is representative of a new class of improved variants of factor VIIa discovered using Catalyst’s proprietary protease engineering platform and know-how.”