24-11-2008: Biovitrum AB and Symphogen A/S have completed the first part of a clinical proof of mechanism study of the recombinant human polyclonal antibody product Sym001 for future prevention of Hemolytic Disease of the Newborn (HDN) that can occur in RhD-negative mothers carrying a RhD-positive fetus. This can lead to an immune reaction causing destruction of the red blood cells in the newborn, which may give rise to severe anemia, jaundice, and even cause heart failure and fatality.
This part of the first clinical study investigated the ability of Sym001 to clear RhD-positive red blood cells given intravenously to 24 RhD-negative healthy males. Positive control was the plasma-derived product Rhophylac®, given to 12 subjects. The preliminary results demonstrate that the recombinant human polyclonal antibody product is able to clear RhD-positive blood cells at five days after dosing in a dose dependent manner.
Biovitrum and Symphogen are now planning for the next step of the clinical programme which should lead to a decision to initiate phase III studies in the intended label population, namely Rh-negative mothers carrying an Rh-positive fetus
"Sym001 is the first ever recombinant human 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 human polyclonal antibodies as well as single monoclonal antibodies which opens an exciting avenue for development of antibody therapeutics addressing unmet medical needs."
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