Bioenvision start AML cancer trial
Bioenvision has announced that the first adult patients have been dosed on a pivotal European Phase II study, to evaluate its lead leukemia compound, clofarabine, in the treatment of adults with Acute Myeloid Leukemia (AML).
Bioenvision has announced that the first adult patients have been dosed on a pivotal European Phase II study, to evaluate its lead leukemia compound, clofarabine, in the treatment of adults with Acute Myeloid Leukemia (AML).
The first patient, from Edinburgh, Scotland will be joined by a further 64 patients from up to 11 other UK hospitals. Many patients with adult acute leukemia are elderly and very unwell as a result of their disease and may, therefore, be unable to tolerate intensive courses of chemotherapy. Such patients are left with very few treatment options that offer hope of a meaningful outcome, and they represent a real unmet clinical need.
The Bioenvision trial of clofarabine is specifically designed to provide such patients with a viable choice of treatment. Accelerated enrolment in the new nine month program of research follows the encouraging results of a preliminary, investigator-led study evaluating clofarabine as a single agent in the same patient category. This closed ahead of time, with the primary objective of the study being exceeded, with a complete response rate of 64% observed in the interim analysis.
Dr Chris Wood, CEO of Bioenvision, commented: 'Enrolling the first patients in this pivotal adult leukemia study is a major milestone for Bioenvision and a further step towards exploiting clofarabine's potential for a wide range of therapeutic indications. The fact that investigators chose to close the preceding investigator-led study earlier than planned because of better than expected results, in favour of instigating this pivotal study is testimony to physician confidence in clofarabine and the encouraging results obtained.'
About Clofarabine
Clofarabine has been granted an 'Orphan Medicinal Product' designation by the European Agency for the Evaluation of Medicinal Products (EMEA) as a treatment for acute lymphoblastic leukemia (ALL) and acute myeloid leukemia. In April 2004, the New Drug Application (NDA) for clofarabine, for the treatment of refractory or relapsed acute leukemia in children was filed to the FDA. Clofarabine is a next-generation purine nucleoside antimetabolite. Nucleoside analogues are antimetabolites that affect DNA synthesis. Clofarabine was rationally designed to combine many of the favourable properties of the two most commonly used nucleoside analogs, fludarabine and cladribine, but is reported to have greater potency at damaging the DNA of Leukemia cells than these other agents.