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Biovitrum and Symphogen have Successfully Completed Phase I Clinical Trial with Recombinant Polyclonal Antibody

07 Feb 2008 - Biovitrum and Symphogen announced the completion of a phase I clinical trial to test the safety and tolerability of Sym001 in healthy volunteers. The results from the dose-escalation, placebo-controlled study show that Sym001 is well tolerated.
 
Sym001 is a recombinant, polyclonal antibody product candidate, comprised of 25 different anti-Rhesus D antibodies. Sym001 is in development for the treatment of Idiopathic/Immune Thrombocytopenic Purpura (ITP) and for Anti RhD Prophylaxis (ADP) of hemolytic disease of the newborn. Symphogen and Biovitrum are jointly developing Sym001 under a co-development and commercialization agreement announced in February 2006. Further clinical development of Sym001 will now be pursued in both indications. Sym001 is a recombinant polyclonal composition of 25 different anti-Rhesus D antibodies for the treatment of Idiopathic Thrombocytopenic Purpura and for Anti RhD Prevention of hemolytic disease of the newborn. Preclinical studies of Sym001 demonstrated its binding potency and biological function similar to existing plasma-derived anti-RhD products.