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Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B
Date:2/12/2009

IB1001, an Intravenous Recombinant Factor IX (rFIX) Product for the Treatment of Hemophilia B

LAGUNA NIGUEL, Calif., Feb. 12 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc., today announced the initiation of a Phase 1 clinical trial of IB1001, an intravenous (IV) recombinant Factor IX (rFIX) product for control and prevention of hemorrhagic episodes in patients with hemophilia B. It is estimated that the market for therapies to treat this disorder is in excess of $600 million.

The Phase 1 clinical trial is designed to assess the safety, tolerability and pharmacokinetics of IB1001 in patients with hemophilia B, compared with the commercially available rFIX product. Following the successful completion of this study, patients will then be followed for the six month Phase 2/3 trial either based on an on-demand or prophylaxis protocol.

"The initiation of this Phase 1 trial is an important milestone for the Company and for the hemophilia community," said John Taylor, Chairman and Co-founder, Inspiration Biopharmaceuticals. "This is the first therapy for hemophilia B patients in the past two decades. We continue to develop a Factor product portfolio in both IV and non-invasive dosage forms for hemophilia and other coagulation disorders."

About IB1001

IB1001 is an intravenous recombinant Factor IX product for the acute and preventative treatment of the bleeding disorder associated with hemophilia B. IB1001 is produced with Inspiration's proprietary recombinant protein manufacturing technology, which significantly increases cell-line productivity.

About Hemophilia

Hemophilia is a lifelong, inherited bleeding disorder caused by low levels or absence of a protein called a clotting factor, essential for blood clotting. This inability to clot results from an error in a person's genetic code, and occurs in approximately 1 in 10,000 male births.
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SOURCE Inspiration Biopharmaceuticals, Inc.
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