In addition to SEAMLESS, we are working with collaborators in investigated sponsored studies to explore sapacitabine in other indications. These studies are where we supply drug product and the cost of the studies are borne by the investigators. These include the Phase II/III Pick a Winner or LI-1 low intensity trial run by the International Cooperative Leukemia Group chaired by Professor Alan Burnett. This is a randomized trial comparing sapacitabine to low-dose cytarabine in patients aged 60 years or older with previously untreated AML or high-risk myelodysplastic syndromes, MDS, who are unfit for intensive chemotherapy. The Phase II part of this study has been completed and over 100 patients have been enrolled. The principal investigator of LI-1 has verbally indicated that based on the observed number of events in the study, the study DSMB is expected to meet later this year to assess overall survival as per protocol.Another investigated sponsored Phase II study, evaluating sapacitabine, in combination with cyclophosphamide and rituximab is being conducted by the Department of Leukemia at the University of Texas and the Anderson Cancer Center. This study is enrolling patients with previously treated chronic lymphocytic leukemia or small lymphocytic leukemia who carry the 11q22-23 deletion. Deletion of chromosome 11q22-23 is associated with the ATM mutation, an important regulator of the HRR DNA repair pathway.
Cyclacel Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript
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