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BioLine Rx Ltd receives approval to commence phase 1 trial for novel stem cell mobilization treatment


Monday, 16 Jun 2014 07:00am EDT 

BioLine Rx Ltd:Receives approval from Israeli Ministry of Health to commence Phase 1 trial for BL-8040, atreatment for mobilization of stem cells from the bone marrow to the peripheral blood circulation.Study is expected to commence during the third quarter of 2014 at Hadassah Medical Center in Jerusalem.Phase 1 study consists of two parts, Part 1 is randomized, double-blind, placebo-controlled dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers.Secondary objectives include assessment of efficacy of BL-8040 in mobilizing stem cells as a stand-alone therapy, as well as determining the pharmacokinetic profile of the drug.This part will be performed in up to 4 cohorts, with 8 healthy volunteers in each cohort.Part 1 of the study will serve to select the optimal safe and efficacious dose of BL-8040 to be used as a stand-alone therapy in Part 2 of the study.Part 2 is an open-label study designed to assess BL-8040's stem cell mobilization capacity, as well as the yield of cells collected by apheresis.Secondary endpoints of the study include evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by apheresis.This part will be performed in a single cohort of 8 healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from Part 1. 

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