Catalyst Biosciences Announces Korean Ministry of Food and Drug Safety Approves Addition of Sixth Cohort to the Phase 1/2 Trial of CB 2679d/ISU304 in Individuals with Hemophilia B
Catalyst Biosciences, Inc. (CBIO)
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Source: GlobeNewswire
Initiation of Phase 2b Trial on Track for Q3 2018 SOUTH SAN FRANCISCO, Calif., April 12, 2018 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (Nasdaq:CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced that the Korean Ministry of Food and Drug Safety (MFDS) approved the addition of a sixth cohort to the Phase 1/2 trial of CB 2679d in individuals with severe hemophilia B following positive data from the multi-dose Cohort 5 that was disclosed on February 9. Cohort 6 will enroll up to five patients. Each individual will receive a single intravenous loading dose of 75 IU/kg, followed by nine daily subcutaneous doses of 150 IU/kg CB 2679d. The loading dose will be administered 30 minutes before the first subcutaneous dose. The study will be completed in South Korea in coordination with the Company’s collaborator ISU Abxis. “The addition of this sixth cohort will allow us to build on the progres
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