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BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040

Published: Thursday, April 11, 2013
Last Updated: Thursday, April 11, 2013
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Final results expected in H2 2014.

BioLineRx has announced that it has received all necessary regulatory approvals in the US to commence 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.

“This program is generating a lot of enthusiasm from our clinical research partners, and we are very pleased that several renowned and respected investigators will be leading our study in the U.S. and Israel,” said Kinneret Savitsky, PhD, CEO of BioLineRx.

Savitsky continued, “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.”

“We are honored to collaborate with BioLineRx on this exciting project,” said Dr. Gautam Borthakur, the principal investigator of the trial at the MD Anderson Cancer Center in Houston, Texas.

Dr. Borthakur continued, “BL-8040 has a unique mechanism of action and has shown very promising pre-clinical and clinical results. Specifically, in pre-clinical studies, BL-8040 showed a CXCR4-dependent, preferential anti-tumor effect against human-derived AML cells. Therefore, we are very pleased to be able to offer this novel therapeutic opportunity to our patients, particularly since AML is still such a big unmet medical need.”

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