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news.New York/Edinburgh company Bioenvision has received promising data from its initial clinical studies of leukemia treatment Evoltra.
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The study used a combination of Evoltra (clofarabine) with the traditional chemotherapy agent daunorubicin. Results showed an overall response had been achieved in 92% of patients over 60 years of age with acute myeloid leukemia (AML).
The phase I/II study involved a total of 30 patients in four cohorts who received different doses of the combined drugs. Initial analysis showed that 11 out of 12 patients in the two lowest dose cohorts achieved a significant response, with 10 of the 12 achieving complete remission.
The dose response data from the patient group taking larger quantities of the drug is still being evaluated. Bioenvision reports that the combination of daunorubacin and Evoltra at the various dose levels has been well tolerated with only minimal toxicity observed. The company now plans to take the drug into phase III testing.
Daunorubicin was sold by NeXstar Pharmaceuticals of California under the name DaunoXome. Since the merger of NeXstar with Gilead Sciences in 1999, the anticancer agent is marketed by the combined companies.