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Bayer Reports Results of Early-Stage Clinical Trials for New Factor VIII Product

The National Hemophilia Foundation does not endorse or assure the products, programs or services featured in eNotes. Further, it cannot make specific recommendations for such products, programs or services.

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