CTI BioPharma today announced findings from an investigator-sponsored Phase 2 trial investigating tosedostat in combination with low-dose cytarabine/Ara-C (LDAC) for the treatment of with either primary acute myeloid leukemia (AML) or AML that has evolved from myelodysplastic syndrome (MDS). Please inform us of your interest and availability to connect with CTI and the Hematology and Stem Cell Transplant Center at AORMN to discuss the data.
Available to speak about this news and the tosedostat program:
• Dr. Giuseppe Visani, Director of Hematology and Stem Cell Transplant Center at AORMN
• Dr. James Bianco, President and CEO of CTI Biopharma
The results were presented at the European Hematology Association (EHA) and the poster for Abstract #P564 is available at www.ctibiopharma.com. Results showed the combination of tosedostat with low dose cytarabine/Ara-C (LDAC) resulted in an overall response rate (ORR) of 54 percent in elderly patients with AML – with 45 percent of patients achieving durable complete responses (CR). Additional trial details:
• Final results presented show that responding patients had a significant improvement in overall survival based on response rates compared to non-responding patients (p=0.018).
• In the intent-to-treat population (ITT), the ORR was 54 percent – with CR observed in 45 percent of patients (n=15/33).
• In the responding patients, the median time for achieving best response was 74 days (range: 22-145 days) and 55 percent (n=10/18) were still in remission after a median follow-up of 319 days.
• A biomarker analysis identified differentially expressed genes between patients that responded to treatment with pacritinib and those that did not (CR vs no CR)
o This shows that achievement of a clinical response could be efficiently predicted by global gene expression profiling
• Safety analysis show that tosedostat in combination with LDAC was generally well tolerated. The primary adverse events observed were pneumonitis (12 percent), cardiac (6 percent), brain hemorrhage (3 percent), and asthenia (3 percent).
Link to news release: http://investors.ctibiopharma.com/phoenix.zhtml?c=92775&p=irol-newsArticle&ID=2059047
About Tosedostat
Tosedostat is an oral aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood-related cancers and solid tumors in Phase 1–2 clinical trials. Tosedostat is currently being evaluated in multiple Phase 2 clinical trials for the treatment of patients with AML or high-risk MDS, which are intended to inform the design for a Phase 3 registration study to support potential regulatory approval.
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