BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) has received regulatory approval in the US to begin a Phase IIa trial for BL-8040, for the treatment of Acute Myeloid Leukemia (AML).
The study is a multicenter, open-label study under an IND, designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adult subjects with relapsed/refractory AML. The primary endpoints of the study are the safety and tolerability of the drug. Secondary endpoints will include the pharmacokinetic profile of the drug and an efficacy evaluation, as assessed by various parameters, such as the response rate by bone marrow biopsy.
The study is also designed in a way that will enable the investigators to evaluate the capabilities of BL-8040 in mobilizing cancer cells from the bone marrow to the peripheral blood, and in inducing their cell death. The study is expected to be conducted in the U.S. and Israel, and will enroll up to 50 patients.
BiolineRX CEO Dr. Kinneret Savitsky said, “AML is one of the most common types of leukemia in adults, yet survival rates continue to be low relative to other leukemias. In particular, treatment options for patients with relapsed or refractory AML are extremely limited, and in many cases, only palliative care is offered. We look forward to the partial results expected towards the end of this year, and have sincere hopes that BL-8040 will be a significant and efficient addition in the battle with this devastating disease.”
BiolineRX's share price rose 8% to NIS 0.70 on the TASE this afternoon.
Published by Globes [online], Israel business news - www.globes-online.com - on April 10, 2013
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