Actinium Posts Positive DMC View On Lomab-B Phase III Trial
Zacks Investment Research | Dec 27, 2017 09:45PM ET
Actinium Pharmaceuticals, Inc. (NYSE:ATNM) announced positive recommendation by an Independent Data Monitoring Committee (“DMC”) for a pivotal phase III SIERRA study, evaluating its lead pipeline candidate, Iomab-B (apamistamab).
Notably, Lomab-B is being developed for conditioning patients prior to a bone marrow transplant (BMT) with relapsed or refractory acute myeloid leukemia (AML) aged 55 years and above.
The phase III study will enroll 150 patients in total with 75 heads per arm. The trial is evaluating the candidate in comparison to chemotherapy as per physician’s choice on AML patients followed by a BMT, also referred to as a hematopoietic stem cell transplant. While the primary endpoint of the study is durable Complete Remission (dCR) at six months post treatment, the secondary endpoint is overall survival at one year.
Additionally, the company stated that it may also request for two ad-hoc efficacy analyses after 70 and/or 110 patients receive the treatment and are given enough time to achieve the primary endpoint.
Significantly, DMC reviewed the initial safety data from the first 20 patients enrolled in the trial in late November. The DMC recommended to continue enrollment for the study. The company said that it expects completion of the trial enrollment by the end of 2018, in line with the prior forecast.
Actinium’s shares have underperformed the Original post
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