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news.Israeli biopharmaceutical firm BioLineRx has completed the dose escalation stage of its ongoing Phase II trial of BL-8040 and started the expansion stage at the optimal dose of this new treatment for acute myeloid leukemia (AML).
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BL-8040 is a clinical-stage drug candidate designed to treat AML, as well as other hematological indications. The company intends to report top-line results from the trial in the fourth quarter of this year.
Around 22 patients participated in this dose escalation stage of the trial and its results showed that all BL-8040 tested doses, up to 1.5mg/kg, were found to be safe and well tolerated when administered in combination with Ara-C (Cytarabine).
BioLineRx chief executive officer Dr Kinneret Savitsky said: "We are greatly encouraged by these interim results and are excited to commence the final stage of this important trial.
"We expect this stage to progress much more quickly than the dose-escalation stage of the trial, which required approval from the data safety monitoring committee before moving to the next dose level.
"We also expect to open additional sites for this stage of the trial. We look forward with much anticipation to announcing top-line results of the trial, which we expect in the fourth quarter of this year."
In an, open-label, dose escalation, safety and efficacy Phase I/II trial in 18 multiple myeloma patients, BL-8040, when combined with G-CSF, showed an excellent safety profile at all doses tested and was highly effective in the mobilization of hematopoietic stem cells and white blood cells from the bone marrow to the peripheral blood.