Bayer Announces Recruitment Achievement for Investigational Hemophilia Treatment Recruitment of first of four cohorts in a Phase II/III study for treatment of Hemophilia A and Hemophilia B patients who have developed neutralizing antibodies, completed
WAYNE, N.J., Nov. 28, 2012 /PRNewswire/ -- Bayer's BAY 86-6150 is being investigated in a Phase II/III study called TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete. Recruitment is ongoing at sites located around the world, including in the U.S., where sites are ready to enroll eligible patients.
The TRUST trial is designed to evaluate the safety and efficacy of the investigational compound BAY 86-6150, a recombinant factor VIIa (rFVIIa) protein in patients with hemophilia A or hemophilia B who have developed neutralizing antibodies, called inhibitors.
"Bayer is committed to finding innovative ways to meet the needs of people with hemophilia, including those affected by the effects of inhibitors to clotting factor replacement therapies," said Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.
About the Phase II/III Trial
The TRUST (TReatment with Unique recombinant rFVIIa 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 composed of two parts: Part A includes the sequential dose escalation for assessing dose response and the pharmacokinetics and pharmacodynamics evaluation. Part B is a confirmatory study to confirm the efficacy and safety of BAY86-6150. Please visit clinicaltrials.gov for more information.
About Hemophilia A, Hemophilia B, and Neutralizing Antibodies ("Inhibitors")
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is largely 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 caused by a deficient or defective blood coagulation protein, known as factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs.
Hemophilia B, also known as Christmas disease, is a less common type of hemophilia. People with hemophilia B have little or no factor IX.
Neutralizing antibodies, or inhibitors, are a serious medical problem that can occur when a person with hemophilia has an immune response to treatment with clotting factor concentrates. About a third of hemophilia patients develop inhibitors, with the development of inhibitors being more common in hemophilia A.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
BAYER and the Bayer Cross are registered trademarks of Bayer.
This news 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 www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Intended for U.S. media only
SOURCE Bayer HealthCare Pharmaceuticals Inc.