Company Update (NASDAQ:CTIC): CTI BioPharma Corp Announces United Kingdom NCRI AML Cooperative Group Advances Tosedostat to Next Stage of “Pick-a-Winner” LI-1 Trial for Older Patients with AML or High-Risk MDS

CTI BioPharma Corp (NASDAQ:CTIC) announced that the United Kingdom’s National Cancer Research Institute (NCRI) Haematological Oncology Clinical Studies Group has chosen to advance tosedostat, the Company’s investigative oral aminopeptidase inhibitor, to the second stage of a randomized clinical trial of low-dose cytarabine plus or minus tosedostat in older patients with Acute Myeloid Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS). The AML Less Intensive (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. Nine regimens have been tested in the Pick-a-Winner program, of which only 4, including tosedostat, have passed the initial hurdle for progression (which requires evidence of an improvement in remission rate with acceptable safety). 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.

“A large portion of older patients and patients with comorbid conditions are poorly suited for conventional intensive chemotherapy due to a high rate of treatment-related mortality. For these patients, there is a significant unmet need for effective and well tolerated alternative therapies,” said Jack Singer, M.D., Chief Scientific Officer of CTI BioPharma. “We are pleased that tosedostat has been selected to continue in this trial and is moving forward to the next stage. Tosedostat has demonstrated encouraging clinical activity in three prior Phase 2 studies in both first-line AML in older patients and in patients who relapsed following standard therapies. Tosedostat is an oral agent given once daily on an outpatient basis that has not been associated with drug-related blood count suppression.” (Original Source)

Shares of CTI BioPharma closed yesterday at $1.20, up $0.10 or 9.09%. CTIC has a 1-year high of $2.94 and a 1-year low of $1.07. The stock’s 50-day moving average is $1.44 and its 200-day moving average is $1.71.

On the ratings front, CTI BioPharma has been the subject of a number of recent research reports. In a report issued on November 9, WallachBeth Capital LLC analyst Bob Ai downgraded CTIC to Hold, with a price target of $1.60, which implies an upside of 33.3% from current levels. Separately, on November 2, Piper Jaffray’s Charles Duncan reiterated a Buy rating on the stock and has a price target of $8.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Bob Ai and Charles Duncan have a total average return of -6.2% and 9.9% respectively. Ai has a success rate of 33.3% and is ranked #2907 out of 3636 analysts, while Duncan has a success rate of 48.7% and is ranked #472.


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