2022-05-19 08:07:44 CLBS Caladrius
05/19/22 05/1908:07 05/19/2208:07 | Caladrius: IDMC recommends continuation of CLBS201 trial without modificationCaladrius Biosciences announced that the Independent Data Monitoring Committee overseeing the Phase 1b, open-label, proof-of-concept study of CLBS201 for the treatment of diabetic kidney disease has reviewed the initial safety and tolerability data from the first two, sequentially treated, patients. Based on their assessment of the data, the IDMC approved proceeding with the enrollment of the remaining four patients in the study without further review. "We are very pleased with the progress of the study and with the recommendations of the IDMC," stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Caladrius. "We find it encouraging that CLBS201 appeared to be well-tolerated based on the initial assessment of data. We look forward to continuing this study and hope to rapidly enroll the remaining patients, leading to top-line data by the first quarter of 2023." |
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