The results, being presented in a poster session at the American Society of Hematology (ASH) 58 th Annual Meeting in San Diego, Calif. from December 3 to 6, 2016, are summarized below:Pharmacokinetics of Subcutaneously Administered CB 2679d/ISU304 in Wild-Type and Hemophilia B Mice (Poster abstract #1389, Session: 321 Blood Coagulation and Fibrinolytic Factors) Seung-Beom Hong, PhD, Howard Levy, MBBChir, PhD, Jae Yong Jung, MS, Minkyung Park, AS, A Rim Seo, AS, So Hyeon Seo, MS and Ed Madison, PhD The authors tested subcutaneous doses of CB 2679d/ISU304 in both hemophilia B and wild-type mice. The wild-type mice also received subcutaneous doses of BeneFIX. Factor IX antigen and activity were measured at various time points. The following conclusions were made:
- There was a dose-dependent increase in plasma Factor IX antigen with subcutaneous CB 2679d/ISU304;
- The pharmacokinetic profile of CB 2679d/ISU304 was similar to BeneFIX when dosed using the same mass, however, CB 2679d/ISU304 has approximately 17-times greater potency;
- Due to the high specific activity of CB 2679d/ISU304, a subcutaneous dose of CB 2679d/ISU304 yields much higher Factor IX activities in mouse plasma compared with the same mass dose of BeneFIX; and
- Daily subcutaneous dosing of CB 2679d/ISU304 demonstrated the effects of the bioavailability, potency, time to maximal concentration, and half-life by reaching a steady-state activity after three days, sufficient to correct severe hemophilia to mild hemophilia in hemophilia B mice.
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