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Bayer HealthCare recently reported progress in the creation of a new recombinant factor VIII (rFVIII) product, BAY 79-4980, for the treatment of patients with hemophilia A. This experimental drug, which is being developed in collaboration with Netherlands-based Zilip Pharma, offers the potential of a factor concentrate with a prolonged half-life, leading to fewer infusions for patients. By formulating rFVIII with Zilip’s patented polyethylene glycol- (PEG) coated liposomes (vesicles composed of fat layers used to deliver drugs or genetic materials directly to targeted sites), Bayer’s BAY 79-4980 is designed to stay active in the body for an extended period. Pegylation, which is a process that helps proteins remain in the body longer, is a key component of the technology. This new product has the potential of lowering the requisite number of prophylaxis infusions to one per week.
Two Phase I clinical trials testing BAY 79-4980’s safety, pharmacokinetics (disposition of a drug in the body) and efficacy in comparison to Bayer’s existing rFVIII product, Kogenate FS®, yielded encouraging results.
A blind, randomized, controlled trial measured safety and pharmacokinetics of both BAY 79-4980 and Kogenate FS®. The lead investigator was Jerry S. Powell, MD, Professor of Hematology and Oncology at the University of California (UC)-Davis School of Medicine. The study, conducted at UC-Davis and the Children’s Hospital of Orange County in Orange, CA, showed no clinically significant differences between the patient group that received Kogenate FS® and the one that was treated with BAY 79-4980.
A second trial was conducted by Zilip Pharma’s parent company, Recoly N.V., and led by Jack Spira, MD, PhD. Spira, who is the Medical Director of Zilip Pharma, reported that hemophilia A patients treated with BAY 79-4980 went an average of 13.3 days without experiencing a bleeding episode, in contrast to 7.2 days for those treated with Kogenate FS®. These results suggest that BAY 79-4980 could be a viable, longer-acting drug.
Data from these Phase I trials were presented at the World Federation of Hemophilia Congress in Vancouver, British Columbia, on May 24, 2006.
Source: Bayer HealthCare news release dated May 24, 2006