BAYER COMPLETES RECRUITMENT FOR PHASE II/III HEMOPHILIA STUDY
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Not intended for U.S. and UK Media - Hemophilia solutions: Bayer completes recruitment of first cohort for novel recombinant factor VIIa (rFVIIa) protein Phase II/III study Investigational new treatment for Hemophilia A and Hemophilia B patients who have developed neutralizing antibodies
Berlin, November 28, 2012 - 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."
About the Phase II/III Study 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.
About neutralizing antibodies ("inhibitors") 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.
About Hemophilia A Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A, the most common type of hemophilia, is characterized by prolonged or spontaneous bleeding, especially into the joints, muscles, or internal organs.
About Hemophilia B Hemophilia B, also known as "Christmas disease," is a less common type of hemophilia. It is characterized by a deficiency in factor IX.
About Bayer HealthCare The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. More information at http://www.healthcare.bayer.com.
Find more information at http://www.bayerpharma.com.
Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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