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Baxter's investigational factor stops bleeding episodes in patients with haemophilia A
Zurich | Monday, July 14, 2003, 08:00 Hrs  [IST]

Preliminary data from a study reported the safety and efficacy of the Antihaemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM), in stopping bleeding episodes in patients with haemophilia A.

rAHF- PFM, an investigational treatment for haemophilia A from Baxter Healthcare Corporation, currently under regulatory review in Europe, the United States, Canada and Switzerland, is a recombinant factor VIII made without any added proteins from human or animal sources in the cell culture process, purification and final formulation.

"rAHF-PFM has prevented bleeding episodes in all circumstances where we have treated patients and where we expected it to work. It has provided excellent coverage for surgical interventions and procedures, and has met all therapy expectations," according to Clinical Study Group Investigator Dr. Amy Shapiro of the Indiana Hemophilia and Thrombosis Center. "Also, because rAHF-PFM is made without the addition of human- or animal-derived proteins in the cell culture and purification processes or final formulation, it removes ongoing concerns about therapy safety that history has shown are legitimate worries."

rAHF-PFM is an investigational blood clotting therapy for haemophilia A to treat and prevent bleeding episodes and control such episodes during surgery. Clinical studies demonstrate that rAHF-PFM, which is infused directly into the bloodstream, works by temporarily raising the level of factor VIII in the blood to a level that allows the body's blood clotting process to function properly. Side effects with the use of rAHF-PFM are uncommon but those reported in the study included: a strange taste, dizziness, hot flashes, headaches, itching at the infusion site, fever, sweating, chills, nausea, diarrhea, shortness of breath and pain in the upper abdomen or lower chest.

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