Bioenvision study finds Evoltra helps survival in elderly AML patients with adverse cytogenetics

New York, June 5 - Bioenvision announced that a pivotal, non-randomized phase 2 study of Evoltra (clofarabine) showed a substantially higher overall complete response rate and a longer median survival than the current standard of care in elderly, high risk patients with acute myeloid leukemia who were considered unsuitable for intensive treatment.

All patients in the study were over 65 years and had either intermediate (70%) or adverse (30%) cytogenetics. The complete response rates were 48% and 42%, respectively.

"These CR [complete response] rates for Evoltra are exceptional, for patients not considered fit for intensive chemotherapy, when you consider that, in our previous studies, none of the patients with adverse cytogenetics responded to our current standard of care, low-dose ara-C," said Alan Burnett, chairman of the U.K. National Cancer Research Institute Hematological Oncology Study Group, in a news release.

The findings were presented at the annual meeting of the American Society of Clinical Oncology in Atlanta.

"In addition," said Burnett, "the higher response rates were translated into a clear survival benefit for patients with the high risk cytogenetic profile. For patients with adverse cytogenetics treated with Evoltra the median survival is already over 6 months, with further follow up scheduled. In comparison patients who are treated with the current standard of care have a median survival of approximately one month."

Bioenvision said the data will form the basis of its filing of the Marketing Authorization Application in Europe.

Bioenvision is a New York biopharmaceutical company with a primary focus on acquisition, development, distribution and marketing of compounds and technologies for the treatment of cancer.

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