CTI BioPharma Corp (NASDAQ:CTIC) reported that the United Kingdom’s NCRI“Haematological Oncology Clinical Studies” Group has finalized to advance tosedostatto the next stage of a randomized clinical study of low-dose cytarabine minus or plus tosedostat in older patients suffering with high risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). The AML LI-1 study is planned as a “Pick-a-Winner” study to be able to simultaneously evaluate numerous promising agents added to standard treatment with low-dose cytarabine in older subjects with MDS or AML who are not fit for standard aggressive induction treatment.
CTI BioPharma Corp (NASDAQ:CTIC) reported that nine therapies have been evaluated in the “Pick-a-Winner” study, of which only four, including tosedostat, have made through the initial obstacle for progression, which needs evidence of enhancement in remission rate with adequatesafety. The ultimate objective of the study is to identify regimens that can double the two-year survival of patients enrolled in this group. Depending on the randomized Phase II interim study, the trial management group decided that tosedostat should advance to the next stage of the trial. It is expected that an additional 110 subjects will be required in such stage. A further assessment will be done before the planned expansion to a 400 enrollments in Phase III trial.
The expert speaks
Jack Singer, M.D., the CSO of CTI BioPharma Corp (NASDAQ:CTIC), said that a large percentage of patients including older patients are poorly apt for traditional intensive chemotherapy following a high-rate of therapy-related mortality. For this group of patients, there is a considerable unmet need for well tolerated and effective alternate treatments. The management is delighted that Tosedostat has been permitted to continue in this study and is entering in the next phase. It has shown promising clinical activity in three previous Phase II trials in first line AML patients.