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Inspiration Biopharmaceuticals Announces Clinical Hold of Clinical Trials Evaluating IB1001 for the Treatment and Prevention of Bleeding in Hemophilia B
Date:7/9/2012

CAMBRIDGE, Mass., July 10, 2012 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the agency has placed a clinical hold on clinical trials evaluating the safety and efficacy of IB1001, an intravenous recombinant factor IX (rFIX) being investigated for the treatment and prevention of bleeding episodes in people with hemophilia B. 

The clinical hold impacts two ongoing IB1001 clinical trials – a phase 3 study evaluating the safety and efficacy of IB1001 to treat and prevent bleeding episodes in adults with hemophilia B, and a phase 3/3b study evaluating the safety and efficacy of IB1001 to treat and prevent bleeding episodes in previously treated pediatric subjects with hemophilia B. The adult study has completed its primary analysis period.

Inspiration recently reported to the FDA that, during the course of routine laboratory evaluations conducted as part of an ongoing phase 3 clinical trial, the Company discovered that a higher proportion of individuals treated with IB1001 have developed antibodies to proteins from the Chinese hamster ovary, or CHO, host cells used to manufacture the therapy than was expected based on earlier study data. Inspiration has notified clinical sites in the U.S. to hold treatment of patients with IB1001. Inspiration is also sharing the FDA directive with regulators in countries outside of the U.S. where the studies are being conducted.

Small amounts of host cell protein are expected and documented in recombinant therapeutic products of all types. Nevertheless, the higher than expected rate of anti-CHO antibody development in people treated with IB1001 has led Inspiration to initiate a thorough investigation.

A total of 86 people with hemophilia B have received IB1001 in clinical studies and, to date, no adverse events related to the development of antibodies to CHO protein ha
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SOURCE Inspiration Biopharmaceuticals, Inc.
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