CTI: UK's NCRI Advances Tosedostat To Next Stage Of AML/MDS Clinical Trial

(RTTNews) - CTI BioPharma Corp. (CTIC) Tuesday announced that its investigative oral aminopeptidase inhibitor, tosedostat, has been selected by the United Kingdom's National Cancer Research Institute or NCRI Haematological Oncology Clinical Studies Group to advance to the second stage of a randomized clinical trial.

The company said the trial is of low-dose cytarabine plus or minus tosedostat in older patients with Acute Myeloid Leukemia or AML or high risk Myelodysplastic Syndrome or MDS.

The AML Less Intensive or LI-1 trial is designed as a "Pick-a-Winner" trial to be able to simultaneously test a number of promising agents added to standard therapy with low-dose cytarabine in older patients with AML or MDS who are unfit for standard aggressive induction therapy.

The ultimate aim of the trial is to identify treatments that can double the 2-year survival of patients in this group. Based on the randomized Phase 2 interim analysis, the trial management group determined that tosedostat should proceed to the next stage of the study.

It is anticipated that an additional 110 patients will be required in such phase. A further evaluation will take place before the intended expansion to a 400 patient Phase 3 trial.

Tosedostat is a potential first-in-class selective inhibitor of aminopeptidases, which are enzymes required by some tumor cells, but not normal cells, to provide a source of amino acids necessary for growth and tumor cell survival.