Phase 2 study data shows Bioenvision's Evoltra as effective as chemotherapy in leukemia treatment

By Lisa Kerner

Charlotte, N.C., June 21 - Bioenvision said new data from its BIOV-121 non-randomized phase 2 clinical study suggests that single agent Evoltra (clofarabine) is as effective as intensive chemotherapy in elderly patients with adverse cytogenetics.

In addition, clofarabine, a next-generation purine nucleoside analog, did not cause the typical intensive treatment side affects of alopecia and mucositis.

All patients enrolled in Bioenvision's pivotal acute myelogenous leukemia (AML) study were greater than 65 years of age and 62% were over 70 years.

Overall response rate for patients over age 70 was 54% and the complete response rate was 49%.

The response rate was 53% and the complete response was 42% in patients with an adverse cytogenetic profile.

"These results show how Evoltra (clofarabine) could improve the lives of thousands of AML patients with adverse cytogenetics who are in desperate need of safe and effective first-line treatment," medical director Andrew Saunders said in a company news release.

"These pivotal data will be an integral part of the Marketing Authorization Application we plan to file in Europe in the coming months so we can make Evoltra available to these critically ill patients."

The BIOV-121 results were presented at the 11th Annual Congress of the European Hematology Association in Amsterdam.

New York-based Bioenvision acquires, develops, distributes and markets compounds and technologies for the treatment of cancer.

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