SECuRE trial advances: No dose limiting toxicities and strong preliminary efficacy data in first multi-dose cohort [Yahoo! Finance]
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Source: Yahoo! Finance
The Safety Review Committee (SRC) assessed early data from the first 3 participants in cohort 4 who received 2 doses of Cu-SAR-bisPSMA. Two of these participants had completed the dose limiting toxicity (DLT) period and 1 will complete the DLT period by the end of September. No DLTs were observed to date, in line with cohorts 1, 2 and 3. The safety profile of multiple doses of Cu-SAR-bisPSMA remains positive, with almost all adverse events (AEs) being mild or moderate. Furthermore, almost all AEs have either resolved or improved at the last assessment. Preliminary efficacy assessment from cohort 4 after 2 therapy cycles in 2 participants following completion of the DLT period showed that both participants exhibited greater than 60% drops in prostate-specific antigen (PSA) levels in weeks following their second dose. The SRC recommended, based on this early data, the SECuRE trial proceeds to enroll the last 3 participants of cohort 4, after which Phase II of the study will comme
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