BioLineRx gains orphan status for novel stem cell mobilization treatment

23 January 2014

Israeli drug developer BioLineRx (TASE: BLRX) has received notice from the US Food and Drug Administration confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the orphan status previously granted for the compound as a treatment for acute myeloid leukemia (AML).

The Orphan Drug Designation was granted for use of BL-8040, in combination with granulocyte colony-stimulating factor (G-CSF), to mobilize human stem cells from the bone marrow to the peripheral blood for collection for autologous or allogeneic (donor-based) transplantation.

"We are very pleased to have our second Orphan Drug Designation for BL-8040, in this case for stem cell mobilization treatment, after already having received the designation last year for the treatment of acute myeloid leukemia," stated Kinneret Savitsky, chief executive of BioLineRx.

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