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Blood, 1 December 2006, Vol. 108, No. 12, pp. 3668-3673. Prepublished online as a Blood First Edition Paper on August 3, 2006; DOI 10.1182/blood-2006-03-008276. This Article Full Text (PDF) All Versions of this Article: blood-2006-03-008276v1 108/12/3668    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Spira, J. Articles by Andreev, Y. Search for Related Content PubMed PubMed Citation Articles by Spira, J. Articles by Andreev, Y. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted March 7, 2006 Accepted July 18, 2006 Prolonged bleeding-free period following prophylactic infusion of recombinant factor VIII (Kogenate® FS) reconstituted with pegylated liposomes Jack Spira*, Olga P. Plyushch, Tatyana A. Andreeva, and Yury Andreev Recoly N.V. Curacao, Netherlands Antilles Center for Hematological Research, The Russian Academy of Medical Sciences, Moscow, Russia Republic Haemophilia Center, St. Petersburg, Russia Reconstructive Orthopedic Surgery Department, Moscow, Russia * Corresponding author; email: jack.spira{at}telia.com. Prophylactic treatment for haemophilia A involves infusion of FVIII concentrates every 2-3 days. Liposomes can be an efficacious vehicle for medicines, and surface modification by PEGylation can prolong liposome circulation time. When reconstituted with PEGylated liposomes (PEGLip), recombinant FVIII (Kogenate® FS; rFVIII-FS) binds non-covalently but with high affinity to the external liposome surface. This preparation showed prolongation of FVIII half life and increased protection from bleeding in preclinical models. Here we report a blinded, controlled, cross-over, multi-center clinical study that evaluated the time free from bleeding episodes in patients with haemophilia A during prophylaxis with standard rFVIII-FS (no liposomes) or PEGLip rFVIII-FS (PEGLip reconstituted) at 25 and 35 IU kg-1 doses. Of 24 enrolled patients, 23 were eligible for efficacy analysis. Mean number of days without bleeds was 7.2± 1.7 with standard rFVIII-FS compared to 13.3± 4.8 with PEGLip rFVIII-FS for the 35 IU kg-1 dose and 5.9± 1.7 with standard rFVIII-FS vs 10.9± 2.9 with PEGLip rFVIII-FS at the 25 IU kg-1 dose (P0.05 between treatment groups for each dose). PEGLip rFVIII-FS was well tolerated. These data suggest that reconstitution of rFVIII-FS with PEGLip may reduce the frequency of treatment during prophylaxis by extending the period between bleeding episodes. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: J. Pan, T. Liu, J.-Y. Kim, D. Zhu, C. Patel, Z.-H. Cui, X. Zhang, J. O. Newgren, A. Reames, D. Canivel, et al. Enhanced efficacy of recombinant FVIII in noncovalent complex with PEGylated liposome in hemophilia A mice Blood, September 24, 2009; 114(13): 2802 - 2811. [Abstract] [Full Text] [PDF]

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