Lorus takes leukemia drug to Phase II

The proof of concept clinical trial demonstrated safety and appropriate dosing of the combination regimen and showed promising clinical responses in patients under 60 years of age. Complete results from the clinical trial are expected to be presented by the investigators in a scientific publication.

The advanced phase II clinical trial, which is now underway, includes both an efficacy study and a novel additional study to measure intracellular target activities and pharmacological synergies between the two agents. In the first stage of the 60 patient trial, the pharmacologic and target related activity of GTI-2040 and high dose Ara-C (HiDAC) will be evaluated in two groups, to determine the contribution of each agent alone and in combination.

Ara-C, including HiDAC, is a key component of nearly all AML regimens, for induction, consolidation or salvage treatment. However even with intensification of the Ara-C, response to treatment in refractory and relapsed disease is limited by development of increasing resistance to Ara-C with repeated exposures.

The second stage of the trial will provide efficacy evaluation in a larger patient population. Canadian biopharmaceutical firm Lorus expects the clinical trial to be completed by the end of 2008.