Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.
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Amgen Inc. is spearheading a clinical study titled ‘A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants With Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)’. The study aims to evaluate the safety and efficacy of subcutaneous blinatumomab in children under 12 years old with these conditions, potentially offering a significant advancement in pediatric leukemia treatment.
The intervention being tested is the drug Blinatumomab, administered as a subcutaneous injection. It is designed to treat children with relapsed/refractory and minimal residual disease positive B-cell precursor acute lymphoblastic leukemia, focusing on determining the recommended Phase 2 dose for pediatric patients.
This interventional study is non-randomized and follows a sequential intervention model without masking, primarily aimed at treatment. It consists of Phase 1b and Phase 2 cohorts, where participants receive blinatumomab to assess its effectiveness and safety.
The study is set to begin recruitment on August 14, 2025, with the primary completion and estimated study completion dates yet to be announced. The last update to the study details was also on August 14, 2025, marking the start of this significant research initiative.
The outcome of this study could have substantial implications for Amgen’s stock performance, as successful results may enhance its market position in the pediatric oncology sector. Investors should watch for updates, as positive data could bolster investor confidence and influence market dynamics, especially in comparison to competitors in the leukemia treatment space.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.