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.
In June, we reported new data at the American Society of Clinical Oncology Annual Meeting on ongoing studies conducted by Cyclacel. In the Phase II randomized trial of all sapacitabine capsules in all the patients with MDS after treatment failure of frontline hypomethylating agents such as azacitidine or Victoza and/or decitabine Dacogen were reported median overall survival for all patients at 252 days or approximately 8.4 months. We will initiate regulatory discussions regarding an appropriate registration plan in this setting after dosing schedule MDS is selected.
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