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news.Sweden-based biopharmaceutical company Biovitrum, and Symphogen, a developer of recombinant humanpolyclonal antibodies, 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 that can occur in RhD-negative mothers carrying RhD-positive fetus.
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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 program 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.
The results show that Sym001 cleared the RhD-positive red blood cells and that the clearance is dose dependent. At the highest dose level of Sym001 studied (900mcg) the clearance at five days after dosing was comparable to that of Rhophylac. Sym001 was found to be safe and well-tolerated at all doses studied.
Martin Nicklasson, CEO of Biovitrum, said: “Clearance of RhD-positive red blood cells from the circulation is key for the prevention of hemolytic disease of the newborn (HDN) and thereby constitutes a significant medical need. It is therefore with great satisfaction we note these positive results which advances the development of this innovative biotechnology therapy to prevent newborns from developing HDN.”