Biovitrum and Symphogen Initiates a Second Clinical study with a Novel Treatment of Hemolytic Diseases
Biovitrum AB and Symphogen A/Sannounced the initiation of a clinical proof of mechanism study to demonstrate the ability of Sym001 (RhD polyclonal antibody) to clear RhD-positive red blood cells from the circulation of RhD-negative healthy volunteers. Clearance of red blood cells by RhD antibodies is an important treatment in preventing hemolytic disease in RhD-positive newborns with RhD-negative mothers.
Sym001 is a new class of biopharmaceuticals for the prevention of hemolytic disease of the newborn by anti-D prophylaxis (ADP), and for the treatment of Idiopathic Thrombocytopenic Purpura (ITP).
"Sym001 is an exciting development candidate that represents a novel and attractive therapeutic option for ADP and ITP. The present study will further contribute to the advancement of our project portfolio, which presently includes nine clinical projects. The Sym001 project fits well with Biovitrum's long experience and broad knowledge within the protein therapeutic area and is perfectly aligned with our specialist care products focus", said Martin Nicklasson, CEO of Biovitrum.
"Sym001 is the first ever recombinant polyclonal antibody product to have entered human clinical trials and this red blood cell challenge study is an important step in the further development of Sym001", said Kirsten Drejer, CEO of Symphogen. "Symphogen's antibody technology platform offers the opportunity to generate compositions of recombinant polyclonal antibodies as well as single monoclonal antibodies which opens an exciting avenue for development of antibody therapeutics addressing unmet medical needs."
Symphogen and Biovitrum are jointly developing Sym001 under a co-development and commercialization agreement. A phase 1 clinical study completed in February 2008 showed that Sym001 is safe and well tolerated in healthy volunteers.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
