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Germany : Bayer completes recruitment of first cohort for novel recombinant factor VIIa (rFVIIa) protein Phase II/III study.

Bayer's BAY 86-6150 is being investigated in a Phase II/III study called TRUST (Treatment with Unique recombinant FVII STudy) and the recruitment of the first cohort is now complete. The investigational compound BAY 86-6150, is a novel recombinant factor VIIa (rFVIIa) protein for potential use in patients with hemophilia A or hemophilia B who have developed neutralizing antibodies called inhibitors.

This novel designed compound is being investigated for its ability to circumvent specific steps of the natural coagulation cascade with the goal of reducing the dosing frequency as compared to the currently available recombinant bypassing agent. Minor modifications in the amino acid composition of BAY 86-6150 increase the circulating half-life of BAY86-6150 and may change its affinity to activated platelets (a key component in the formation of a clot).

A Phase I multicenter, randomized, double-blind, placebo-controlled, single-dose escalation study on BAY86-6150 has already been successfully completed.

Through our Hemophilia Solutions research initiatives, Bayer continues to investigate innovative ways to meet the needs of people with hemophilia, including those affected by the devastating effects of inhibitors to clotting factor replacement therapies, said Dr Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. If it can achieve its goal, BAY 86-6150 may help patients with inhibitors achieve better control of their disease.

The TRUST (TReatment with Unique recombinant FVII STudy) trial is a Phase II / III, multicenter, open-label clinical study which will assess the safety and efficacy of BAY 86-6150 in patients with hemophilia A or B with inhibitors. The study is comprised of two parts: Part A includes the sequential dose escalation for assessing dose response and the pharmacokinetics and pharmacodynamics evaluation. Part B is to further investigate the efficacy and safety of a selected dose determined from Part A.

Inhibitor formation is considered by leading hemophilia organizations such as the World Federation of Hemophilia as the most serious complication facing people with hemophilia today. While standard treatment of hemophilia is replacement therapy of the deficient clotting factor by intravenous injection of clotting factor VIII or factor IX, some patients may develop antibodies against these therapeutic products, rendering standard treatment ineffective in the control of bleeding events. These neutralizing antibodies are termed inhibitors. Hemophilia patients with inhibitors generally exhibit frequent bleeding that are difficult to control, and have a greater risk of debilitating injury and death. Approximately 4,000 hemophilia patients with inhibitors are known worldwide.

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Publication:Mena Report
Date:Nov 29, 2012
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