Bioenvision says Evoltra achieves high response rates in adult leukemia

By E. Janene Geiss

Philadelphia, April 5 - Bioenvision, Inc. announced Wednesday that an overall response had been achieved in 92% of patients over 60 year old with acute myeloid leukemia given a combination of Evoltra (clofarabine) and daunorubicin as first-line treatment.

The phase 1/2 dose-ranging study of Evoltra in combination with daunorubicin had been performed as part of the AML16 intensive trial conducted by the National Cancer Research Institute, according to a company news release.

A total of 30 patients in four cohorts have received daunorubicin (50 mg daily) plus Evoltra in doses ranging from 15 mg to 30 mg.

Response data have been analyzed on the first two dose cohorts, which took 15 mg and 20 mg. Of 12 patients, 92% achieved a response with 83% reaching complete remission, officials said.

The remaining dose cohorts have now been fully recruited and response data are being evaluated. The combination of daunorubacin and Evoltra at the various dose levels has been well-tolerated with only minimal toxicity observed, officials said.

These interim data were presented at the British Society of Hematology 46th annual scientific meeting in Edinburgh, Scotland.

The success of this study now enables a phase 3 study to be initiated, which will randomize patients to receive either the combination of Evoltra plus daunorubacin or the current standard of care, ara-C plus daunorubacin, officials said.

"We are pleased with the excellent responses we are seeing in these patients with Evoltra, and especially how well the patients tolerate the drug combination," Christopher Wood, chief executive officer and chairman of Bioenvision, said in the release.

On Feb. 23, the Committee for Medicinal Products for Human Use adopted a positive opinion for the use of Evoltra (clofarabine) in the treatment of acute lymphoblastic leukemia in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients less than or equal to 21 years old at initial diagnosis.

Bioenvision also is developing Evoltra for the treatment of adult acute myeloid leukemia as first-line therapy. The company said it has completed enrollment of its phase 2 clinical trial for the treatment of adult AML in elderly patients unfit for intensive chemotherapy and expects to file a Marketing Authorization Application in mid-2006 for the company's first label-extension for Evoltra, officials said.

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. The company also is developing anti-infective technologies, including the Oligon technology, an advanced biomaterial that has been incorporated into various FDA-approved medical devices.

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