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Inspiration Biopharmaceuticals Initiates Second Pivotal Clinical Study of Innovative Hemophilia Therapy OBI-1
Date:11/27/2011

hilia A is caused by a factor VIII deficiency and the congenital form occurs in ~1 out of every 5,000 male births.  Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of every 30,000 male births.  Approximately 60% of persons with hemophilia have a severe condition, which results in frequent spontaneous bleeding episodes, in addition to serious bleeding after injuries.  The annual market for hemophilia treatments is estimated at $8 billion worldwide.

Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to human FVIII, and can no longer respond to replacement treatment with the coagulation factor.  Current therapies, specifically human factor VIIa (NovoSeven®) and FEIBA, work by bypassing the natural hemostatic pathway.

About OBI-1OBI-1, a recombinant form of porcine FVIII which may possess low cross reactivity to antihuman FVIII antibodies, is a replacement therapy, facilitating the intrinsic hemostatic pathway.  This should allow clinicians to correlate activity and efficacy with FVIII levels, a surrogate for efficacy in hemophilia, and therefore guide dosing to better monitor and predict treatment outcomes.  OBI-1 presents a unique and alternative approach to address the needs of individuals who have developed inhibitors to FVIII and is highly desired by the medical community.

For more information about enrolling in one of Inspiration's clinical trials, please visit www.hemophiliaregistry.com or call 1-800-361-3227.  For more information on the ongoing clinical studies, please visit http://www.clinicaltrials.gov.

About Inspiration BiopharmaceuticalsInspiration Biopharmaceuticals is dedicated exclusively to developing treatments for hemophilia, with a primary mission to broaden access to care, including prophylactic therapy, and to improve t
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SOURCE Inspiration Biopharmaceuticals, Inc.
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