One set of interim results are from a phase II multi-center, international study designed to further evaluate clofarabine in older adult patients with acute myeloid leukemia (AML) who are unsuitable for intensive chemotherapy.
To date, a total of 23 patients have been enrolled in the study and, of the 12 evaluable patients, a complete response rate of 58% has been observed. An additional three patients achieved a partial response, giving a combined response rate of 83%.
The initial patients were enrolled mainly in the UK, but new centers have now been initiated in Ireland, Italy and France and enrollment is expected to increase rapidly.
The other interim results are from a European pediatric relapsed/refractory acute lymphoblastic leukemia (ALL) study. A total of 23 patients have been enrolled and, of the 12 evaluable patients, 42% achieved a complete response, as determined by the investigators.
“This is exciting news for clofarabine and for Bioenvision,” said Dr Christopher Wood, chairman and CEO of Bioenvision. “These clinical results will form an important part of our regulatory strategy in Europe.”