Clofarabine's Positive Results Confirmed at International Symposium

March 22, 2005

Bioenvision has announced interim results from the ongoing clinical studies of clofarabine in pediatric and adult acute leukemia trials that confirm clofarabine's outstanding profile observed in previous studies.

Alan Burnett and Varsha Ghandhi, world-renowned leukemia experts, recently presented data from clofarabine's ongoing clinical development program at the Sixth International Symposium and Expert Workshops on Leukemia and Lymphoma in Amsterdam, Netherlands.

Burnett, chairman of the UK National Cancer Research Institute Hematological Oncology Study Group, presented the first interim analysis of the Phase II, multicenter, international study designed to further evaluate clofarabine in older adult patients with acute myeloid leukemia 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 percent has been observed by the investigators. An additional three patients achieved a partial response giving a combined response rate of 83 percent.

Ghandhi of the M.D. Anderson Cancer Center, in Houston, shared the interim results from the European pediatric relapsed/refractory acute lymphoblastic leukemia multicenter study. A total of 23 patients have been enrolled and, of the 12 evaluable patients, 42 percent achieved a complete response, as determined by the investigators.

Clofarabine was recently approved by the FDA in the U.S. for the treatment of relapsed/refractory pediatric acute lymphocytic leukemia.