Bayer Emerges as a Bio Force
7/12/2007
PEGylated Forms of Recombinant Factor VIII Show Extended Time of Activity
Geneva, Switzerland (July 12, 2007) – New preclinical data presented at the 21st Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Geneva, Switzerland, demonstrate that PEGylated forms of recombinant factor VIII (rFVIII) prolong bleeding protection. The studies, conducted by Bayer HealthCare, investigated rFVIII molecule variants in animal models and demonstrated prolonged control of bleeding.
"Developing a longer-acting FVIII product is high on Bayer’s priority list, and the positive findings from our preclinical studies presented this week represent a major step forward," said Glenn Pierce, MD, PhD, Vice President, Applied Research and U.S Medical Affairs, Hematology/Cardiology, Bayer HealthCare Pharmaceuticals. “We as a company are committed to innovative research and development of next-generation therapies that produce significant patient benefits. FVIII therapy with prolonged activity could greatly improve patient outcomes through increased ease of compliance and greater access to higher treatment standards at a lower total cost of treatment in the long run.”
The primary approach for prolonging activity involves site-specific PEGylation2 of a variant of the human FVIII molecule. By adjusting the number and size of PEGylation attachments, as well as the sites of attachment to the FVIII molecule, Bayer scientists have demonstrated an increase in the duration of activity of the PEGylated FVIII molecules in animal models. The PEGylated molecules are also able to retain activity in the presence of specific inhibitors.
The following abstracts featured this work:
Site-Specific PEGylation of rFVIII Results in Prolonged In Vivo Efficacy (Murphy, et al: Abstract P-T-022)
This study investigated the attachment of differing molecular weight PEG moieties3 to specific sites of the rFVIII molecule to determine the effects on plasma half-life and the ability to prevent bleeding in mouse models. Results indicate that site-specific PEGylation can be accomplished and that larger PEG moieties exhibit a significant increase in plasma circulation, up to two-fold, while maintaining efficacy, suggesting that site-specific PEGylation of rFVIII is a viable approach for prolonging activity of rFVIII.
