DREIEICH, Germany I March 21, 2013 I Biotest announced today that Biotest intends to start an additional Phase IIb trial with up to 350 patients with Tregalizumab (BT-061), a monoclonal antibody in development for the treatment of Rheumatoid Arthritis. Tregalizumab, which activates regulatory T-cells of the patient’s immune system with its unique mechanism of action, will be administered in combination with methotrexate for a treatment period of six months. Patients showing a therapeutic response can be treated for an extended period (so called "Extension Phase"). The drug is manufactured at Biotest’s own facility in Boca Raton, Florida. The patients will receive multiple subcutaneous administrations. The study will be conducted in multiple clinical centers in different regions of the world including the USA, Canada and Europe.
The decision for Biotest’s biggest Phase IIb trial ever, is based on first results of an interim analysis of the currently ongoing clinical trial (study 979) in which patients are being treated over twelve weeks with the antibody in combination with methotrexate.
The company can only disclose the data of the interim analysis once all data will be unblinded. Otherwise a risk that doctors and patients involved in the ongoing part of the study might be biased – can not be excluded.
The new study will be called TREAT 2b (T cell REgulating Arthritis Trial 2b). The submission of this study to the regulatory bodies is planned for spring 2013.
Prof. Dr. Gregor Schulz, CEO of Biotest AG, calls the decision to proceed with this new clinical trial an important milestone in the development of Treglizumab and emphasizes the importance of the project for the company.
SOURCE: Biotest
Post Views: 66
DREIEICH, Germany I March 21, 2013 I Biotest announced today that Biotest intends to start an additional Phase IIb trial with up to 350 patients with Tregalizumab (BT-061), a monoclonal antibody in development for the treatment of Rheumatoid Arthritis. Tregalizumab, which activates regulatory T-cells of the patient’s immune system with its unique mechanism of action, will be administered in combination with methotrexate for a treatment period of six months. Patients showing a therapeutic response can be treated for an extended period (so called "Extension Phase"). The drug is manufactured at Biotest’s own facility in Boca Raton, Florida. The patients will receive multiple subcutaneous administrations. The study will be conducted in multiple clinical centers in different regions of the world including the USA, Canada and Europe.
The decision for Biotest’s biggest Phase IIb trial ever, is based on first results of an interim analysis of the currently ongoing clinical trial (study 979) in which patients are being treated over twelve weeks with the antibody in combination with methotrexate.
The company can only disclose the data of the interim analysis once all data will be unblinded. Otherwise a risk that doctors and patients involved in the ongoing part of the study might be biased – can not be excluded.
The new study will be called TREAT 2b (T cell REgulating Arthritis Trial 2b). The submission of this study to the regulatory bodies is planned for spring 2013.
Prof. Dr. Gregor Schulz, CEO of Biotest AG, calls the decision to proceed with this new clinical trial an important milestone in the development of Treglizumab and emphasizes the importance of the project for the company.
SOURCE: Biotest
Post Views: 66
