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Inspiration Biopharmaceuticals Presents Key Scientific Data from its Two Lead Hemophilia Development Programs at the 53rd Annual Meeting of the American Society of Hematology (ASH)
Date:12/12/2011

bleeds occur.  These data confirm results previously reported by investigators at the ISTH meeting in July 2011, which suggested that IB1001 is at least as good as the existing, marketed recombinant FIX product.  In addition, no inhibitors have been observed to date in clinical studies involving IB1001.

"Currently, individuals with hemophilia B are limited to only one approved recombinant product.  An alternative recombinant FIX product, such as IB1001, will increase product availability and choice, and help encourage the use of optimal therapeutic regimens such as prophylaxis."

A second poster presentation, titled "Recombinant Porcine Factor VIII Corrects Thrombin Generation and Improves Clot Structure In Vitro in Plasma Containing Anti-Factor VIII Inhibitory Antibodies", further characterized the in vitro capacity of OBI-1 to correct surrogate markers of hemostasis depending on the anti-porcine FVIII titer.  Results were presented from blood samples of 14 individuals with congenital hemophilia.  OBI-1 corrected thrombin generation when added to hemophilia A plasma samples with low and mid OBI-1 inhibitor titers. These in vitro data suggest that this correction is correlated with the OBI-1 inhibitor levels and not the human FVIII inhibitor levels.  The data also suggest that OBI-1 may potentially restore thrombin generation in the presence of an OBI-1 inhibitor titer higher than 10 BU/mL.

Dr. Gomperts commented, "We are very encouraged by the OBI-1 study results.  OBI-1, which may possess low cross reactivity to antihuman FVIII antibodies, facilitates the intrinsic hemostatic pathway.  This may allow clinicians to correlate activity and efficacy with FVIII levels and therefore guide dosing to better monitor and predict treatment outcomes."

John P. Butler, Chief Executive Officer of Inspiration Biopharmaceuticals, stated, "We are very pleased with the positive momentum of our IB
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SOURCE Inspiration Biopharmaceuticals
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Related medicine technology :

1. Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
2. Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B
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10. Inspiration Biopharmaceuticals Announces Data from OBI-1 Pivotal-Stage Program in Hemophilia at 23rd ISTH Congress
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