Bayer Announces Recruitment Achievement for Investigational Hemophilia
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
WAYNE, N.J., Nov. 28, 2012
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
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
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
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.
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
Contact: Jane Ward, Bayer HealthCare, +1-973-305-5248, firstname.lastname@example.org
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